| Introduced | Sep 27, 2013 |
| Referred to Committee | Sep 27, 2013 |
| Passed House | Sep 28, 2013 |
| Passed Senate | ... |
| Signed by the President | ... |
Monday, September 30, 2013
H.R. 3204 - 42% chance of being enacted
BGOV Bill Summary: H.R. 3204, Drug Compounding and Supply Safety
(Bloomberg)
-- The Food and Drug Administration’s oversight of compounded drugs would be
expanded and the U.S. for the first time would have uniform standards to
monitor drug distribution from factories to pharmacies under H.R. 3204.
The
bill, which reflects an informal House-Senate agreement on the issues, would
allow the FDA to collect and spend fees to cover the costs of inspecting drug
compounding sites and to license programs for providers of logistics services
for drugmakers, wholesalers and dispensers.
The
measure would impose handling and recordkeeping requirements on drug companies
and create notification rules for drugs that are potentially unsuitable for
distribution.
The bill
responds to regulatory gaps revealed by investigations into 50
meningitis-related deaths last year that resulted from tainted medications
linked to a compounding pharmacy. It would replace a patchwork of state laws
governing distribution of drugs through about 4 billion prescriptions a year
filled by compounding and traditional pharmacies, the Senate Health, Education, Labor and Pensions and House Energy and Commerce committees said in a joint statement.
Compounding
Provisions
The FDA
has cited conflicting legal decisions about its authority over compounders to
deflect criticism that the agency didn’t act quickly to close New England Compounding Pharmacy Inc.,
the company at the center of the meningitis outbreak in October 2012 that
killed more than 50 people. FDA Commissioner Margaret Hamburg has
called for legislation to clarify the agency’s role.
Compounding
pharmacies traditionally prepare personalized prescriptions, typically by
mixing ingredients together, that are sent directly to patients or hospitals
and are regulated by state health authorities. The meningitis outbreak revealed
that some companies go beyond that task to produce larger amounts of medicines
without or in advance of a prescription, acting more like a drugmaker that
would be overseen by the FDA.
“This
legislation will improve the safety of compounded drugs by clarifying the oversight
responsibilities of the FDA over large-volume compounders and by holding
facilities to high quality standards,” Iowa Democrat Tom Harkin, who heads the
Senate HELP committee, said in the statement. “This bill also calls for an unprecedented tracing
system that will track prescription drugs from manufacturing to distribution.”
Manufacturers
of traditional drugs that don’t go directly to customers would have to maintain
transaction information for at least six years, imprint a product identifier to
each package within four years of the bill’s enactment, use only authorized
trading partners and set up product verification systems within a year of
enactment.
Drugmakers
also would need to quarantine illegitimate products, and keep a sample for
further testing by the maker or government health officials. Distributors,
dispensers, repackagers and third-party logistics providers couldn’t accept
products without getting the full transaction history.
The
legislation would draw a distinction between traditional compounding, which
would still be regulated mainly by state pharmacy boards, and compounding
makers that produce sterile products without or ahead of receiving
prescriptions and which sell those products across state lines.
The
measure would permit drug compounders that practice outside the scope of
traditional pharmacy practice of making drugs to fill specific prescriptions to
register as outsourcing facilities subject to the FDA oversight. That would
enable the FDA to identify providers and products, get reports on adverse
reactions and make risk-based inspections.
Starting
on Oct. 1, 2014, the Health and Human Services Department would assess and
collect fees. Inspection fees for outsourcers would be $15,000 multiplied by an
inflation adjustment factor. Businesses with less than $1 million in annual
sales could apply to have their fees reduced to a third of the amount paid by
larger businesses.
Supply
Chain
The
measure would create a uniform federal standard for tracking drugs to replace
state laws that would result in electronic, interoperable unit-level drug
tracking for the country in 10 years.
A
unit-level system would require each bottle or vial to have an identifier;
that’s different than a lot-level approach in which each unit produced in the
same manufacturing lot would have the same identifier.
Drugmakers
would be required to imprint lot-level product identifiers on all drug packages
within four years of the bill becoming law. Within five years of the bill’s
enactment, repackagers would be prohibited from accepting a shipment that
doesn’t include identifiers.
Pharmacies
would be barred from accepting drug shipments that lack identifiers within
seven years of enactment.
An
existing California law set to go into effect in January 2015 has many of the
same requirements as the proposed national standard. The implementation of
strict traceability standards in the most populous state would make many
drugmakers and wholesalers act as if such a national standard were in place
anyway, according to Brian Rye, a Bloomberg Government senior health-care
analyst.
CBO
Estimate
The measure
would increase revenue and direct spending from criminal and civil penalties by
less than $500,000 per year, with “negligible net effects” on the deficit,
according to the Congressional Budget office cost estimate.
CBO said
that the bill would result in net discretionary outlays of $27 million from
fiscal 2014 through 2018.
Group
Positions
SUPPORTERS
include businesses such as United Parcel
Service Inc. and pharmaceutical maker Perrigo Co. that benefit
from prescriptions filled by mail, the 32-member Healthcare Distribution Management
Association and the National
Community Pharmacists Association trade groups, and more than a
dozen patient advocacy organizations such as the Susan G. Komen Advocacy Alliance,
the Prevent Cancer Foundation
and the Lymphoma Research Foundation.
The bill
“helps Perrigo, our Michigan-based manufacturing facilities and our employees
avoid millions of dollars’ worth of duplicative government regulation and red
tape by imposing a nationally uniform system for tracking and tracing prescription
drugs,” the company’s chief financial officer, Judy Brown, said in a
letter yesterday.
OPPONENTS
include the International
Academy of Compounding Pharmacists. The organization said the bill
won’t protect the American public, lacks key definitions to govern compounding
practice, and doesn’t take into account input from the compounding profession
provided to Congress during the past year.
Previous
Action
The
relevant House and Senate committee chairmen and ranking members announced
Sept. 26 they had reached agreement on the compounding and tracking-systems
legislation.
The
bill, which reflects the agreement, was introduced Sept. 27 by Fred Upton of Michigan,
the Republican chairman of the Energy and Commerce Committee.
On May
22, the Senate HELP Committee approved and combined by voice vote two bills: S. 959,
which focused on trying to improve compounding pharmacy quality and
accountability, and S. 957,
dealing with the drug supply chain. On July 24, the panel released an amended version
of the bill that modified a handful of provisions. The bill had five
co-sponsors, three Democrats and two Republicans, as of Sept. 26.
On June
3, the House passed, by voice vote, H.R. 1919,
which would direct the FDA to establish national standards for monitoring the
distribution of prescription drugs at the unit level. It was introduced by Ohio
Republican Bob Latta.
The bill doesn’t address compounding pharmacies.
Prospects
The
House is scheduled to consider the bill Sept. 28 under suspension of the rules,
which limits debate to 40 minutes, bars amendments, and requires a two-thirds
majority for passage.
If
passed by the House, the measure would go to the Senate for further action.
The
White House hasn’t issued a statement of administration policy on the measure.
Use of Propofol In Executions Could Result In Anesthetic Shortage, EU Sanctions
The state of Missouri plans to execute a death row inmate next month using for the first time a lethal dose of the widely-used anesthesia drug propofol. The European Union (EU), where most of the U.S. propofol supply is manufactured and capital punishment is banned, is warning that export sanctions may be imposed on the drug, which could cause shortages in the U.S. that may endanger patients’ lives.
Propofol made headlines recently for being the drug that claimed the life of Michael Jackson. In clinical practice, propofol is the anesthetic of choice, used in four out of five anesthetic procedures. Every year, 50 million vials of propofol are administered in 15,000 hospitals and clinics throughout the U.S, according to the Associated Press. Anesthesiologists prefer using propofol over other sedatives because it works quickly and patients wake up sooner with less side effects.
As for death by lethal injection, propofol has yet to be tested much less studied. Opponents to the death penalty and the drug's use point out that using the anesthetic does not guarantee that prisoners will die a pain-free death. Furthermore, it is unknown what dose of propofol is required to execute a person.
Allen Nicklasson, the prisoner on death row, is scheduled to die at 12:01 a.m. Oct. 23. He was convicted of killing a man who stopped on the side of the road to help him with his car in 1994. On Nov. 20, Joseph Franklin is scheduled to be executed, also by lethal injection. Franklin was convicted of a series of racially-motivated killings and the bombing of a synagogue.
About 85 percent of the U.S. supply of propofol is manufactured by Fresenius Kabi, a German company. The European Union (EU) not only opposes the death penalty, but also prohibits the trade of goods that could be used for capital punishment. The EU has expressed that the drug could be subject to tighter regulations if Missouri follows through with the execution as planned.
“It’s our belief they would be compelled to impose export controls,” said Matt Kuhn, spokesman for Fresenius Kabi USA, in an interview with the Associated Press. “How soon it would be after an execution is not clear.”
The regulations would not be a complete ban. Instead manufacturers would have to apply to export authorities in Europe for each shipment, which can be a 3-6 month process. The delay could lead to widespread propofol shortages nationwide. Propofol shortages have occurred in the past due to manufacturing level issues such as recalls, but have been resolved. The American Society of Anesthesiologists has stated that interruptions in the propofol supply caused longer recovery times for patients and even deaths.
“We do consider this a critical need,” said Erica Jefferson of the FDA. “Without the drug we’re concerned that surgeries would be delayed and patients would be at risk.”
Prison officials have turned to propofol after manufacturers of sodium thiopental, the drug traditionally used for lethal injections, stopped selling the drug to prisons in opposition to their use in executions.
http://www.medicaldaily.com/use-propofol-executions-could-result-anesthetic-shortage-eu-sanctions-258461
Propofol made headlines recently for being the drug that claimed the life of Michael Jackson. In clinical practice, propofol is the anesthetic of choice, used in four out of five anesthetic procedures. Every year, 50 million vials of propofol are administered in 15,000 hospitals and clinics throughout the U.S, according to the Associated Press. Anesthesiologists prefer using propofol over other sedatives because it works quickly and patients wake up sooner with less side effects.
As for death by lethal injection, propofol has yet to be tested much less studied. Opponents to the death penalty and the drug's use point out that using the anesthetic does not guarantee that prisoners will die a pain-free death. Furthermore, it is unknown what dose of propofol is required to execute a person.
Allen Nicklasson, the prisoner on death row, is scheduled to die at 12:01 a.m. Oct. 23. He was convicted of killing a man who stopped on the side of the road to help him with his car in 1994. On Nov. 20, Joseph Franklin is scheduled to be executed, also by lethal injection. Franklin was convicted of a series of racially-motivated killings and the bombing of a synagogue.
About 85 percent of the U.S. supply of propofol is manufactured by Fresenius Kabi, a German company. The European Union (EU) not only opposes the death penalty, but also prohibits the trade of goods that could be used for capital punishment. The EU has expressed that the drug could be subject to tighter regulations if Missouri follows through with the execution as planned.
“It’s our belief they would be compelled to impose export controls,” said Matt Kuhn, spokesman for Fresenius Kabi USA, in an interview with the Associated Press. “How soon it would be after an execution is not clear.”
The regulations would not be a complete ban. Instead manufacturers would have to apply to export authorities in Europe for each shipment, which can be a 3-6 month process. The delay could lead to widespread propofol shortages nationwide. Propofol shortages have occurred in the past due to manufacturing level issues such as recalls, but have been resolved. The American Society of Anesthesiologists has stated that interruptions in the propofol supply caused longer recovery times for patients and even deaths.
“We do consider this a critical need,” said Erica Jefferson of the FDA. “Without the drug we’re concerned that surgeries would be delayed and patients would be at risk.”
Prison officials have turned to propofol after manufacturers of sodium thiopental, the drug traditionally used for lethal injections, stopped selling the drug to prisons in opposition to their use in executions.
http://www.medicaldaily.com/use-propofol-executions-could-result-anesthetic-shortage-eu-sanctions-258461
House OKs bill aimed at improving drug safety
WASHINGTON (AP) — The House easily approved bipartisan legislation Saturday aimed at improving the safety of drugs produced by compounding pharmacies that mix customized pharmaceuticals.
The measure, approved on a voice vote, comes almost a year after a meningitis outbreak that killed 64 people and sickened hundreds more was traced to a compounding company in Framingham, Mass. Inspectors later found unsanitary conditions at the New England Compounding Center, which has since closed.
The measure, aimed at improving how drugs are tracked from production until they are purchased at a drug store, would clarify what sponsors said was confusion over the Food and Drug Administration's authority over compounded drugs. It would also require the agency to coordinate its oversight of compounded-drug safety with states.
Compounders could voluntarily register as outsourcing facilities, which would bring them under FDA authority. Registering will let the agency identify who these companies are and what they produce, and allow the FDA to receive reports about any problems.
Companies that remain traditional pharmacies would continue to be overseen mostly by state pharmacy boards.
The Senate is working on similar legislation.
"We are near the resolution of last year's deadly outbreak," said Rep. Fred Upton, R-Mich., chairman of the House Energy and Commerce Committee and an author of the legislation.
That panel's top Democrat, Rep. Henry Waxman of California, said, "There is no question that this bill represents a step forward."
Rep. Rosa DeLauro, D-Conn., criticized the legislation, saying its voluntary registration for compounding companies "is not strong enough to ensure the public safety."
http://health.usnews.com/health-news/news/articles/2013/09/28/house-oks-bill-aimed-at-improving-drug-safety
The measure, approved on a voice vote, comes almost a year after a meningitis outbreak that killed 64 people and sickened hundreds more was traced to a compounding company in Framingham, Mass. Inspectors later found unsanitary conditions at the New England Compounding Center, which has since closed.
The measure, aimed at improving how drugs are tracked from production until they are purchased at a drug store, would clarify what sponsors said was confusion over the Food and Drug Administration's authority over compounded drugs. It would also require the agency to coordinate its oversight of compounded-drug safety with states.
Compounders could voluntarily register as outsourcing facilities, which would bring them under FDA authority. Registering will let the agency identify who these companies are and what they produce, and allow the FDA to receive reports about any problems.
Companies that remain traditional pharmacies would continue to be overseen mostly by state pharmacy boards.
The Senate is working on similar legislation.
"We are near the resolution of last year's deadly outbreak," said Rep. Fred Upton, R-Mich., chairman of the House Energy and Commerce Committee and an author of the legislation.
That panel's top Democrat, Rep. Henry Waxman of California, said, "There is no question that this bill represents a step forward."
Rep. Rosa DeLauro, D-Conn., criticized the legislation, saying its voluntary registration for compounding companies "is not strong enough to ensure the public safety."
http://health.usnews.com/health-news/news/articles/2013/09/28/house-oks-bill-aimed-at-improving-drug-safety
House Passes Bill That Would Give Drug Makers More FDA Scrutiny
The U.S. House passed legislation that would give the government its first uniform rules to help identify stolen or counterfeit drugs and would put manufacturers under greater regulatory scrutiny.
The voice vote on H.R. 3204, which was written in response to dozens of deaths linked to contaminated medicines, sends the measure to the Senate.
“Bad actors concerned more with profit than public health will not be able to operate with impunity again,” said Representative Gene Green, a Texas Democrat.
The bill would let the Food and Drug Administration collect and spend fees to cover costs of inspections and licensing, impose handling and record-keeping requirements, and create notification rules for drugs that are potentially unsuitable for distribution.
The legislation was introduced in response to regulatory gaps revealed by investigations into meningitis-related deaths last year that resulted from tainted medications linked to a compounding pharmacy. Its provisions would replace a patchwork of state laws governing distribution of drugs through about 4 billion prescriptions a year filled by compounding and traditional pharmacies, the Senate Health, Education, Labor and Pensions and House Energy and Commerce committees said in approving the measure Sept. 26.
“How we got here is a tragedy,” said Representative Timothy Murphy, a Republican from Pennsylvania, said during today’s debate.
The FDA came under criticism from Congress for failing to close New England Compounding Pharmacy Inc. before the Framingham, Massachusetts-based company shipped fungus-tainted medications to customers across the U.S. in last year’s meningitis outbreak. The company subsequently filed for bankruptcy.
The FDA told lawmakers that its legal authority over compounding pharmacies needed to be clarified, which the lawmakers said would happen if this bill becomes law.
The FDA reported last year that it had discovered counterfeit versions of Roche Holding AG (RHHBY:US)’s cancer medicine Avastin -- containing no active ingredient -- in boxes identifying the contents as Altuzan, the version of the drug that is sold in Turkey and hasn’t been approved for use in the U.S. In 2008 the FDA recalled Baxter International Inc. (BAX:US)’s blood thinner heparin due to contamination of an ingredient imported from China; during the crisis, neither the FDA nor Baxter was able to re-create the supply chain, taking weeks to get close to the source, according to a report last year by the Institute of Medicine, part of the Washington-based National Academies of Sciences.
Under the legislation, manufacturers, repackagers, wholesale distributors and dispensers would, within seven years, be maintaining and sharing records of key information about each drug’s distribution history.
The measure would let larger drug compounders that produce pharmaceuticals by the batch, rather than one prescription at a time, register as outsourcing facilities subject to FDA oversight. That would enable the FDA to identify providers and products, get reports on adverse reactions and make risk-based inspections.
Compounding pharmacies prepare personalized prescriptions and are regulated by state health authorities. Some companies also produce larger amounts of blended medicines.
A Senate committee staff report released in May found that in the eight months after last year’s meningitis outbreak caused by contaminated compounded drugs, at least 48 compounding companies were found to be producing and selling drugs contaminated or created in unsafe conditions. In at least three cases, visible contamination was spotted in widely distributed sterile compound drugs.
The report also found that according to FDA documents between 2001 and 2011, at least 25 deaths and 36 serious injuries, including hospitalizations, were linked to large-scale drug compounding companies, including 13 deaths in 2011. The figures may understate the actual number of adverse events because current law doesn’t require reporting of those events.
http://www.businessweek.com/news/2013-09-28/house-passes-bill-that-would-give-drug-makers-more-fda-scrutiny
The voice vote on H.R. 3204, which was written in response to dozens of deaths linked to contaminated medicines, sends the measure to the Senate.
“Bad actors concerned more with profit than public health will not be able to operate with impunity again,” said Representative Gene Green, a Texas Democrat.
The bill would let the Food and Drug Administration collect and spend fees to cover costs of inspections and licensing, impose handling and record-keeping requirements, and create notification rules for drugs that are potentially unsuitable for distribution.
The legislation was introduced in response to regulatory gaps revealed by investigations into meningitis-related deaths last year that resulted from tainted medications linked to a compounding pharmacy. Its provisions would replace a patchwork of state laws governing distribution of drugs through about 4 billion prescriptions a year filled by compounding and traditional pharmacies, the Senate Health, Education, Labor and Pensions and House Energy and Commerce committees said in approving the measure Sept. 26.
“How we got here is a tragedy,” said Representative Timothy Murphy, a Republican from Pennsylvania, said during today’s debate.
The FDA came under criticism from Congress for failing to close New England Compounding Pharmacy Inc. before the Framingham, Massachusetts-based company shipped fungus-tainted medications to customers across the U.S. in last year’s meningitis outbreak. The company subsequently filed for bankruptcy.
The FDA told lawmakers that its legal authority over compounding pharmacies needed to be clarified, which the lawmakers said would happen if this bill becomes law.
The FDA reported last year that it had discovered counterfeit versions of Roche Holding AG (RHHBY:US)’s cancer medicine Avastin -- containing no active ingredient -- in boxes identifying the contents as Altuzan, the version of the drug that is sold in Turkey and hasn’t been approved for use in the U.S. In 2008 the FDA recalled Baxter International Inc. (BAX:US)’s blood thinner heparin due to contamination of an ingredient imported from China; during the crisis, neither the FDA nor Baxter was able to re-create the supply chain, taking weeks to get close to the source, according to a report last year by the Institute of Medicine, part of the Washington-based National Academies of Sciences.
Under the legislation, manufacturers, repackagers, wholesale distributors and dispensers would, within seven years, be maintaining and sharing records of key information about each drug’s distribution history.
The measure would let larger drug compounders that produce pharmaceuticals by the batch, rather than one prescription at a time, register as outsourcing facilities subject to FDA oversight. That would enable the FDA to identify providers and products, get reports on adverse reactions and make risk-based inspections.
Compounding pharmacies prepare personalized prescriptions and are regulated by state health authorities. Some companies also produce larger amounts of blended medicines.
A Senate committee staff report released in May found that in the eight months after last year’s meningitis outbreak caused by contaminated compounded drugs, at least 48 compounding companies were found to be producing and selling drugs contaminated or created in unsafe conditions. In at least three cases, visible contamination was spotted in widely distributed sterile compound drugs.
The report also found that according to FDA documents between 2001 and 2011, at least 25 deaths and 36 serious injuries, including hospitalizations, were linked to large-scale drug compounding companies, including 13 deaths in 2011. The figures may understate the actual number of adverse events because current law doesn’t require reporting of those events.
http://www.businessweek.com/news/2013-09-28/house-passes-bill-that-would-give-drug-makers-more-fda-scrutiny
'Brinksmanship' kept Congress from addressing issue
U.S. Sen. Debbie Stabenow said “political brinksmanship” has kept Congress from addressing real and important issues like the need for stronger oversight of large compounding pharmacies.
The Lansing Democrat said the fungal meningitis outbreak that began a year ago as a result of tainted steroids has not received proper attention in Congress.
“That is why I am continuing to fight for the Pharmaceutical Compounding Quality and Accountability Act that the Senate Health, Education, Labor and Pensions Committee has put forward in this effort to protect families,” Stabenow said in a statement emailed to the Daily Press & Argus.
She said she wants immediate passage of the compounding pharmacy bill.
Stabenow; U.S. Rep. Mike Rogers, R-Howell; and U.S. Sen. Carl Levin, D-Detroit, declined to be interviewed for this series. Their offices each issued statements.
Michigan was the hardest-hit of the 20 states where fungal meningitis cases occurred and were linked to injections of tainted steroids.
Nationwide, 750 cases of fungal infection were reported, resulting in 64 deaths, according to the latest statistics issued by the federal Centers for Disease Control and Prevention.
In Michigan, 264 cases resulted in 19 deaths.
Eight deaths occurred in Livingston County and one in Ingham County, which make up much of Rogers’ congressional district.
Kelsey Knight, Rogers’ spokeswoman, issued this statement: “Congressman Rogers is a senior member of the Energy and Commerce Committee, which has jurisdiction over federal health agencies including (the Food and Drug Administration), CDC, and (the National Institutes of Health). He continues to work with his colleagues to investigate this tragedy and ensure it never happens again. This ongoing investigation has thus far determined that a sole manufacturer — the New England Compounding Center in Framingham, Massachusetts — was responsible for tainted steroids which caused the outbreak.
“Unfortunately, hearings at the Energy and Commerce Committee have also found that FDA and Massachusetts regulators failed to do their jobs and did not take action even after knowing NECC was jeopardizing the safety of patients. This regulatory breakdown is unacceptable, and Congressman Rogers continues to examine all options for ensuring it does not happen again. One piece of bipartisan legislation currently being reviewed is H.R. 3089, the Compounding Clarity Act, which would provide FDA new authorities to oversee compounding pharmacies.”
Rogers was not a co-sponsor of the bill, but Knight said he supports it.
Levin’s office said he is pushing leadership to act quickly on a new compounding pharmacy bill.
“There has been a yearlong, high-priority effort in both houses of Congress to strengthen federal authority to regulate mass compounding facilities and lay the groundwork for a nationwide system to track prescription drugs so we can prevent future tragedies like this one,” Levin said by email in a statement issued Friday. “Earlier this week, a bipartisan group from the House and Senate reached agreement on legislation aimed at meeting those goals,” he added.
Stabenow said she led questioning of the Center for Medicare and Medicaid Services about the oversight of payments for compounded medications in the wake of the outbreak.
“This forced CMS to shed light on their process for responding when a pharmacy has received an FDA violation, and made it clear that more FDA oversight of large scale compounding pharmacies is needed to ensure that concerns are brought to the attention of CMS and medical providers,” she said.
http://www.livingstondaily.com/article/20130929/NEWS01/309290020
The Lansing Democrat said the fungal meningitis outbreak that began a year ago as a result of tainted steroids has not received proper attention in Congress.
“That is why I am continuing to fight for the Pharmaceutical Compounding Quality and Accountability Act that the Senate Health, Education, Labor and Pensions Committee has put forward in this effort to protect families,” Stabenow said in a statement emailed to the Daily Press & Argus.
She said she wants immediate passage of the compounding pharmacy bill.
Stabenow; U.S. Rep. Mike Rogers, R-Howell; and U.S. Sen. Carl Levin, D-Detroit, declined to be interviewed for this series. Their offices each issued statements.
Michigan was the hardest-hit of the 20 states where fungal meningitis cases occurred and were linked to injections of tainted steroids.
Nationwide, 750 cases of fungal infection were reported, resulting in 64 deaths, according to the latest statistics issued by the federal Centers for Disease Control and Prevention.
In Michigan, 264 cases resulted in 19 deaths.
Eight deaths occurred in Livingston County and one in Ingham County, which make up much of Rogers’ congressional district.
Kelsey Knight, Rogers’ spokeswoman, issued this statement: “Congressman Rogers is a senior member of the Energy and Commerce Committee, which has jurisdiction over federal health agencies including (the Food and Drug Administration), CDC, and (the National Institutes of Health). He continues to work with his colleagues to investigate this tragedy and ensure it never happens again. This ongoing investigation has thus far determined that a sole manufacturer — the New England Compounding Center in Framingham, Massachusetts — was responsible for tainted steroids which caused the outbreak.
“Unfortunately, hearings at the Energy and Commerce Committee have also found that FDA and Massachusetts regulators failed to do their jobs and did not take action even after knowing NECC was jeopardizing the safety of patients. This regulatory breakdown is unacceptable, and Congressman Rogers continues to examine all options for ensuring it does not happen again. One piece of bipartisan legislation currently being reviewed is H.R. 3089, the Compounding Clarity Act, which would provide FDA new authorities to oversee compounding pharmacies.”
Rogers was not a co-sponsor of the bill, but Knight said he supports it.
Levin’s office said he is pushing leadership to act quickly on a new compounding pharmacy bill.
“There has been a yearlong, high-priority effort in both houses of Congress to strengthen federal authority to regulate mass compounding facilities and lay the groundwork for a nationwide system to track prescription drugs so we can prevent future tragedies like this one,” Levin said by email in a statement issued Friday. “Earlier this week, a bipartisan group from the House and Senate reached agreement on legislation aimed at meeting those goals,” he added.
Stabenow said she led questioning of the Center for Medicare and Medicaid Services about the oversight of payments for compounded medications in the wake of the outbreak.
“This forced CMS to shed light on their process for responding when a pharmacy has received an FDA violation, and made it clear that more FDA oversight of large scale compounding pharmacies is needed to ensure that concerns are brought to the attention of CMS and medical providers,” she said.
http://www.livingstondaily.com/article/20130929/NEWS01/309290020
Congress, FDA playing blame game on outbreak
A year of finger-pointing Congress and the U.S. Food and Drug Administration culminated last week in the introduction of legislation that would give the FDA greater oversight over larger compounding pharmacies.
The bill was negotiated between the House and Senate and was announced Wednesday, a year after the first cases of fungal meningitis linked to tainted steroids from the New England Compounding Center were announced.
The final proposal followed hearings on the meningitis outbreak and investigations into both NECC and the FDA.
The focal point of the hearings was the November appearance of Barry Cadden, president and co-owner of the now-defunct NECC. Cadden pleaded the Fifth Amendment when he refused to comment before the U.S. House Energy and Commerce Committee.
Some members of Congress, including U.S. Rep. Mike Rogers, R-Howell, who sits on the committee, repeatedly said the FDA and state of Massachusetts were to blame for the meningitis outbreak because they knew about prior problems but did not act.
Former U.S. Rep. Cliff Stearns, R-Fla., in a hearing said a timeline of events suggests the FDA and Massachusetts Board of Pharmacy failed to prevent the meningitis outbreak. Stearns said the FDA conducted a series of inspections three times at NECC prior to the outbreak, each based on a separate complaints or events.
Stearns said the Massachusetts Board of Pharmacy had investigated at least 12 complaints against NECC or Cadden since the pharmacy opened in 1998.
“Over the course of these inspections, regulators noted the same kinds of problems at issue in the current outbreak — problems with sterility and violations of its license,” Stearns said in November.
For example, Stearns said, several “adverse events” were reported to the FDA in 2002 regarding steroid injections produced by NECC. He said the FDA inspected the pharmacy, and that six months after the inspections, patients were hospitalized after receiving NECC injections and displaying meningitis-type symptoms.
Stearns said the steroid product at issue in the 2002 hospitalizations was the same steroid that caused last year’s meningitis outbreak.
The FDA maintains it didn’t fall down on the job because Congress didn’t give it the job to begin with. Regular oversight of compounding pharmacies, under law, is left to individual state boards of pharmacy, not the FDA.
If Congress wanted more FDA oversight of compounding pharmacies, the government would have to give it to the FDA, agency officials said.
The debate on the regulation of compounding pharmacies dates back to the early 1990s, when pharmacy compounding was at an all-time high in the country, FDA officials said.
In November 1997, the FDA Modernization Act was enacted, exempting compounding pharmacies from FDA drug approvals in exchange for the drug producers not promoting or advertising their compounded products.
In testimony in July, Dr. Janet Woodcock of the FDA told the Energy and Commerce Committee that the FDA first became concerned with compounding pharmacies in the early 1990s, when it realized compounding was rapidly growing.
In response, the FDA in 1992 issued a series of guidelines on compounding procedures that was met with objection from the pharmaceutical industry, Woodcock said.
She said the next major event was passage of the FDA Modernization Act of 1997 that exempted compounded drugs from FDA approval.
Federal law exempts certain compounding pharmacies from registration and the requirement to permit access to records during an inspection, she added.
“As a result, FDA has limited knowledge of pharmacy compounders and compounding practices and limited ability to oversee their activities,” Woodcock said.
Eight months after the FDA Modernization Act became law, the New England Compounding Center was issued its pharmacy license.
In April 2002, the U.S. Supreme Court ruled that prohibiting advertising or promoting of compounded drugs under the FDA Modernization Act was unconstitutional. That ruling left in place pharmacies’ exemption from FDA drug approvals, however.
Massachusetts previously inspected NECC in 2011. It again inspected the facility last year just after news of the outbreak, and NECC surrendered its license Oct. 3 and recalled all of its products three days later.
The fact that Congress, not state legislatures, has the power to regulate across state lines compounded drugs distribution hasn’t fazed some state lawmakers, including state Sen. Joe Hune, R-Hamburg Township.
On Sept. 19, Hune announced legislation that would require every compounding pharmacy in Michigan to have a “pharmacist in charge” who would be responsible for all activity at the location.
Michigan compounding pharmacists would be required to maintain records detailing all compounding drugs, including the product’s name, strength, formula and the name of the pharmacist who approved the compound.
Also under Hune’s forthcoming bills, all those engaged in compounding medications would be required to submit to state inspections at least once during every two-year licensing cycle.
“Let’s get people to act. Let’s get some penalties out there,” Hune said.
“We’re working on a solution to go forward. I don’t think it’s just a federal issue,” he added.
But the state measures would not have prevented last year’s meningitis outbreak.
The outbreak was caused by batches of tainted pain injections produced in Massachusetts and distributed across the country, including to Michigan.
Still, U.S. Sen Carl Levin, D-Detroit, in a statement agreed the state should have a role in tightening oversight of compounding pharmacies and preventing another tragedy.
The stepmother of state Rep. Bill Rogers, R-Genoa Township, was infected with tainted steroids from NECC.
Bill Rogers said it appears the FDA, more so than Michigan, will be able to regulate the reach of out-of-state compounding pharmacies and prevent another outbreak.
He said the Legislature should prevent compounding pharmacies with violations in other states from opening up shop in Michigan under different names.
http://www.livingstondaily.com/article/20130929/NEWS01/309290008/Congress-FDA-playing-blame-game-outbreak
The bill was negotiated between the House and Senate and was announced Wednesday, a year after the first cases of fungal meningitis linked to tainted steroids from the New England Compounding Center were announced.
The final proposal followed hearings on the meningitis outbreak and investigations into both NECC and the FDA.
The focal point of the hearings was the November appearance of Barry Cadden, president and co-owner of the now-defunct NECC. Cadden pleaded the Fifth Amendment when he refused to comment before the U.S. House Energy and Commerce Committee.
Some members of Congress, including U.S. Rep. Mike Rogers, R-Howell, who sits on the committee, repeatedly said the FDA and state of Massachusetts were to blame for the meningitis outbreak because they knew about prior problems but did not act.
Former U.S. Rep. Cliff Stearns, R-Fla., in a hearing said a timeline of events suggests the FDA and Massachusetts Board of Pharmacy failed to prevent the meningitis outbreak. Stearns said the FDA conducted a series of inspections three times at NECC prior to the outbreak, each based on a separate complaints or events.
Stearns said the Massachusetts Board of Pharmacy had investigated at least 12 complaints against NECC or Cadden since the pharmacy opened in 1998.
“Over the course of these inspections, regulators noted the same kinds of problems at issue in the current outbreak — problems with sterility and violations of its license,” Stearns said in November.
For example, Stearns said, several “adverse events” were reported to the FDA in 2002 regarding steroid injections produced by NECC. He said the FDA inspected the pharmacy, and that six months after the inspections, patients were hospitalized after receiving NECC injections and displaying meningitis-type symptoms.
Stearns said the steroid product at issue in the 2002 hospitalizations was the same steroid that caused last year’s meningitis outbreak.
The FDA maintains it didn’t fall down on the job because Congress didn’t give it the job to begin with. Regular oversight of compounding pharmacies, under law, is left to individual state boards of pharmacy, not the FDA.
If Congress wanted more FDA oversight of compounding pharmacies, the government would have to give it to the FDA, agency officials said.
The debate on the regulation of compounding pharmacies dates back to the early 1990s, when pharmacy compounding was at an all-time high in the country, FDA officials said.
In November 1997, the FDA Modernization Act was enacted, exempting compounding pharmacies from FDA drug approvals in exchange for the drug producers not promoting or advertising their compounded products.
In testimony in July, Dr. Janet Woodcock of the FDA told the Energy and Commerce Committee that the FDA first became concerned with compounding pharmacies in the early 1990s, when it realized compounding was rapidly growing.
In response, the FDA in 1992 issued a series of guidelines on compounding procedures that was met with objection from the pharmaceutical industry, Woodcock said.
She said the next major event was passage of the FDA Modernization Act of 1997 that exempted compounded drugs from FDA approval.
Federal law exempts certain compounding pharmacies from registration and the requirement to permit access to records during an inspection, she added.
“As a result, FDA has limited knowledge of pharmacy compounders and compounding practices and limited ability to oversee their activities,” Woodcock said.
Eight months after the FDA Modernization Act became law, the New England Compounding Center was issued its pharmacy license.
In April 2002, the U.S. Supreme Court ruled that prohibiting advertising or promoting of compounded drugs under the FDA Modernization Act was unconstitutional. That ruling left in place pharmacies’ exemption from FDA drug approvals, however.
Massachusetts previously inspected NECC in 2011. It again inspected the facility last year just after news of the outbreak, and NECC surrendered its license Oct. 3 and recalled all of its products three days later.
The fact that Congress, not state legislatures, has the power to regulate across state lines compounded drugs distribution hasn’t fazed some state lawmakers, including state Sen. Joe Hune, R-Hamburg Township.
On Sept. 19, Hune announced legislation that would require every compounding pharmacy in Michigan to have a “pharmacist in charge” who would be responsible for all activity at the location.
Michigan compounding pharmacists would be required to maintain records detailing all compounding drugs, including the product’s name, strength, formula and the name of the pharmacist who approved the compound.
Also under Hune’s forthcoming bills, all those engaged in compounding medications would be required to submit to state inspections at least once during every two-year licensing cycle.
“Let’s get people to act. Let’s get some penalties out there,” Hune said.
“We’re working on a solution to go forward. I don’t think it’s just a federal issue,” he added.
But the state measures would not have prevented last year’s meningitis outbreak.
The outbreak was caused by batches of tainted pain injections produced in Massachusetts and distributed across the country, including to Michigan.
Still, U.S. Sen Carl Levin, D-Detroit, in a statement agreed the state should have a role in tightening oversight of compounding pharmacies and preventing another tragedy.
The stepmother of state Rep. Bill Rogers, R-Genoa Township, was infected with tainted steroids from NECC.
Bill Rogers said it appears the FDA, more so than Michigan, will be able to regulate the reach of out-of-state compounding pharmacies and prevent another outbreak.
He said the Legislature should prevent compounding pharmacies with violations in other states from opening up shop in Michigan under different names.
http://www.livingstondaily.com/article/20130929/NEWS01/309290008/Congress-FDA-playing-blame-game-outbreak
Today's Shortages
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Sunday, September 29, 2013
Drug Safety Bill Approved By House In Bipartisan Fashion
WASHINGTON — The House easily approved bipartisan legislation Saturday aimed at improving the safety of drugs produced by compounding pharmacies that mix customized pharmaceuticals.
The measure, approved on a voice vote, comes almost a year after a meningitis outbreak that killed 64 people and sickened hundreds more was traced to a compounding company in Framingham, Mass. Inspectors later found unsanitary conditions at the New England Compounding Center, which has since closed.
The measure, aimed at improving how drugs are tracked from production until they are purchased at a drug store, would clarify what sponsors said was confusion over the Food and Drug Administration's authority over compounded drugs. It would also require the agency to coordinate its oversight of compounded-drug safety with states.
Compounders could voluntarily register as outsourcing facilities, which would bring them under FDA authority. Registering will let the agency identify who these companies are and what they produce, and allow the FDA to receive reports about any problems.
Companies that remain traditional pharmacies would continue to be overseen mostly by state pharmacy boards.
The Senate is working on similar legislation.
"We are near the resolution of last year's deadly outbreak," said Rep. Fred Upton, R-Mich., chairman of the House Energy and Commerce Committee and an author of the legislation.
That panel's top Democrat, Rep. Henry Waxman of California, said, "There is no question that this bill represents a step forward."
Rep. Rosa DeLauro, D-Conn., criticized the legislation, saying its voluntary registration for compounding companies "is not strong enough to ensure the public safety."
http://www.huffingtonpost.com/2013/09/28/drug-safety-bill_n_4009794.html
The measure, approved on a voice vote, comes almost a year after a meningitis outbreak that killed 64 people and sickened hundreds more was traced to a compounding company in Framingham, Mass. Inspectors later found unsanitary conditions at the New England Compounding Center, which has since closed.
The measure, aimed at improving how drugs are tracked from production until they are purchased at a drug store, would clarify what sponsors said was confusion over the Food and Drug Administration's authority over compounded drugs. It would also require the agency to coordinate its oversight of compounded-drug safety with states.
Compounders could voluntarily register as outsourcing facilities, which would bring them under FDA authority. Registering will let the agency identify who these companies are and what they produce, and allow the FDA to receive reports about any problems.
Companies that remain traditional pharmacies would continue to be overseen mostly by state pharmacy boards.
The Senate is working on similar legislation.
"We are near the resolution of last year's deadly outbreak," said Rep. Fred Upton, R-Mich., chairman of the House Energy and Commerce Committee and an author of the legislation.
That panel's top Democrat, Rep. Henry Waxman of California, said, "There is no question that this bill represents a step forward."
Rep. Rosa DeLauro, D-Conn., criticized the legislation, saying its voluntary registration for compounding companies "is not strong enough to ensure the public safety."
http://www.huffingtonpost.com/2013/09/28/drug-safety-bill_n_4009794.html
Bill calls for tracing compounded drugs to prevent contamination, Pallone says
A new U.S. Congressional bill that would help ensure the safety of compounded drugs and the nation’s pharmaceutical supply chain deserves support, said U.S. Rep. Frank J. Pallone Jr., D-N.J., the top Democrat on the House Energy and Commerce Health Subcommittee.
Pallone co-authored the bipartisan Drug Quality and Security Act or H.R. 3204, which was developed partly in response to last year’s meningitis outbreak in Massachusetts caused by contaminated compounded drugs mixed at the New England Compounding Center, which killed 64 people and sickened 750 more, said Pallone in a release.
He called those events “tragic.”
“Today, we are taking a critical step forward in securing the safety of our drug supply chain by creating a product tracing system and improving the quality of compounded drugs, which unfortunately have operated in the past under a faulty law,” Pallone said. “This legislation will allow (U.S. Food and Drug Administration) to require higher standards for certain drugs and better protect the public health.”
Compounding pharmacies mix drugs tailored to specific patient needs. This legislation clarifies current federal law regarding traditional pharmacy compounding to apply a uniform standard nationwide, according to the release.
Compounders will have the opportunity to register as outsourcing facilities subject to oversight by the U.S. Food and Drug Administration in much the same way as traditional manufacturers are monitored. FDA will know who these outsourcers are and what they are making, receive adverse event reports about compounded drugs and have the authority and resources to conduct risk-based inspections.
The bill also would create a uniform framework for tracking drugs from the manufacturer to the pharmacy. There is currently no system for tracking the drugs that make up some four billion prescriptions per year in the U.S. which means drugs that are stolen or counterfeit may not be discovered before reaching consumers, Pallone said.
http://www.app.com/article/20130928/NJNEWS/309280057/Bill-calls-tracing-compounded-drugs-prevent-contamination-Pallone-says?nclick_check=1
Pallone co-authored the bipartisan Drug Quality and Security Act or H.R. 3204, which was developed partly in response to last year’s meningitis outbreak in Massachusetts caused by contaminated compounded drugs mixed at the New England Compounding Center, which killed 64 people and sickened 750 more, said Pallone in a release.
He called those events “tragic.”
“Today, we are taking a critical step forward in securing the safety of our drug supply chain by creating a product tracing system and improving the quality of compounded drugs, which unfortunately have operated in the past under a faulty law,” Pallone said. “This legislation will allow (U.S. Food and Drug Administration) to require higher standards for certain drugs and better protect the public health.”
Compounding pharmacies mix drugs tailored to specific patient needs. This legislation clarifies current federal law regarding traditional pharmacy compounding to apply a uniform standard nationwide, according to the release.
Compounders will have the opportunity to register as outsourcing facilities subject to oversight by the U.S. Food and Drug Administration in much the same way as traditional manufacturers are monitored. FDA will know who these outsourcers are and what they are making, receive adverse event reports about compounded drugs and have the authority and resources to conduct risk-based inspections.
The bill also would create a uniform framework for tracking drugs from the manufacturer to the pharmacy. There is currently no system for tracking the drugs that make up some four billion prescriptions per year in the U.S. which means drugs that are stolen or counterfeit may not be discovered before reaching consumers, Pallone said.
http://www.app.com/article/20130928/NJNEWS/309280057/Bill-calls-tracing-compounded-drugs-prevent-contamination-Pallone-says?nclick_check=1
House Passes Bipartisan Compounding Bill
Federal efforts to remedy the regulatory failures that led to last fall's deadly fungal meningitis outbreak moved a step closer to reality on Sept. 28 as the U.S. House of Representatives passed the Drug Quality and Security Act.
The legislation would strengthen the FDA's authority over larger compounding pharmacies that manufacture customized medicines in bulk quantities for intra- and interstate distribution. The bill also establishes a "track and trace" system to monitor the distribution of prescription medicines from manufacture to end user. The measure seeks to prevent counterfeit drugs from entering the pharmaceutical supply chain.
The new legislation, which was finalized by House and Senate committee members earlier this week, focuses largely on correcting the regulatory no-man's land between traditional compounders and pharmaceutical manufacturers by creating a new class of nontraditional compounders, called "outsourcing facilities." Under the bill, outsourcing facilities would have to register annually with the FDA and submit twice-yearly reports identifying the drug products compounded during the previous six months. However, registration would be voluntary. Outsourcers with annual revenues exceeding $1 million would have to shell out substantial registration and inspection fees that would go to pay for oversight costs.
While regulation of traditional compounders would remain under state pharmacy board jurisdiction, the bills would demand much greater communication and cooperation between the FDA and state boards.
Paul W. Abramowitz, PharmD, ScD (Hon.), chief executive of the American Society of Health-System Pharmacists, said in a statement that "overall, ASHP is supportive of this proposal. The addition of the outsourcing facility category will help promote the safety of products that health care providers and the public receive from compounding outsourcers." Dr. Abramowitz added, however, that the organization was "disappointed that the bill did not go further to require compounding outsourcing facilities to register with the FDA, and create clearer risk-based criteria to help the FDA identify outsourcers that are operating outside the scope of traditional pharmacy compounding."
Outsourcing facilities could also elect to remain classified as traditional compounders. Dr. Abramowitz said that loophole "leaves the door open for large-scale compounding pharmacies to potentially behave like manufacturers without the oversight of the FDA."
The bill does not specifically address one concern of health system and hospital pharmacies. That is, they want to maintain their status as state-regulated traditional compounders, with the freedom to prepare medicines and nutritional supplements for both individual patients and in larger quantities for anticipated needs based on historical demand, without the additional federal regulatory burden imposed on outsourcing facilities.
The Senate's original version of the compounding legislation issued last May contained clear language granting them that status, but it is not included in the new Senate-House bill.
The central thrust of the new bill is ensuring medication safety. Lawmakers want to avoid another public health disaster like last fall's meningitis crisis, which ultimately claimed 64 lives among 760 individuals with confirmed fungal infections attributed to contaminated methylprednisolone injections made by the now-shuttered New England Compounding Center. Stepped-up inspections by the FDA and state pharmacy boards over the last year have uncovered many more instances of pharmacies in violation of sterility standards, most of them larger compounders that make and distribute products to doctors' offices, health systems and hospitals across the country.
Under the new bill, pharmacies would be prevented from compounding complex, difficult-to-manufacture products. The new bill doesn't specify which products, but the original House version issued earlier this month cited examples such as biologic drugs, metered dose inhalers, transdermal patches and sterile liposomal products.
The new bill also requires that any pharmacy compounding a drug subject to a risk evaluation and mitigation strategy (REMS) would have to demonstrate prior to compounding that the pharmacist or physician is using controls comparable to those applicable under the REMS.
It would also prevent compounders from making copycat versions of patented and approved drugs, but would grant leeway for drugs in short supply.
The National Community Pharmacists Associating strongly endorsed the bill. "This compromise legislation appropriately addresses the issues that led to the NECC tragedy, protects the physician-patient-pharmacist relationship, maintains critical patient access to compounded medications, and strengthens the pharmaceutical supply chain," said R. Douglas Hoey, RPh, MBA, chief executive officer of NCPA.
Not everyone expressed support for the new bill, which now goes to the Senate for a vote. Michael A. Carome, MD, deputy director of Public Citizen's Health Research Group, said the bill would "make it easier for companies like the NECC to manufacture substandard drugs like the one that caused the outbreak" without FDA approval "under the guise of pharmacy compounding." Dr. Carome said the agency already has the authority to take action against pharmacies "that engage in illegal compounding, but the agency has failed to fully exercise this authority."
He also said the creation of the new category of outsourcing pharmacies would allow companies, registering under this designation, to "mass-produce standardized drug products without seeking FDA premarket approval, particularly during drug shortages. This kind of large-scale production is not compounding, it is manufacturing."
http://www.pharmacypracticenews.com/ViewArticle.aspx?d=Policy&d_id=51&i=September+2013&i_id=992&a_id=24156
The legislation would strengthen the FDA's authority over larger compounding pharmacies that manufacture customized medicines in bulk quantities for intra- and interstate distribution. The bill also establishes a "track and trace" system to monitor the distribution of prescription medicines from manufacture to end user. The measure seeks to prevent counterfeit drugs from entering the pharmaceutical supply chain.
The new legislation, which was finalized by House and Senate committee members earlier this week, focuses largely on correcting the regulatory no-man's land between traditional compounders and pharmaceutical manufacturers by creating a new class of nontraditional compounders, called "outsourcing facilities." Under the bill, outsourcing facilities would have to register annually with the FDA and submit twice-yearly reports identifying the drug products compounded during the previous six months. However, registration would be voluntary. Outsourcers with annual revenues exceeding $1 million would have to shell out substantial registration and inspection fees that would go to pay for oversight costs.
While regulation of traditional compounders would remain under state pharmacy board jurisdiction, the bills would demand much greater communication and cooperation between the FDA and state boards.
Paul W. Abramowitz, PharmD, ScD (Hon.), chief executive of the American Society of Health-System Pharmacists, said in a statement that "overall, ASHP is supportive of this proposal. The addition of the outsourcing facility category will help promote the safety of products that health care providers and the public receive from compounding outsourcers." Dr. Abramowitz added, however, that the organization was "disappointed that the bill did not go further to require compounding outsourcing facilities to register with the FDA, and create clearer risk-based criteria to help the FDA identify outsourcers that are operating outside the scope of traditional pharmacy compounding."
Outsourcing facilities could also elect to remain classified as traditional compounders. Dr. Abramowitz said that loophole "leaves the door open for large-scale compounding pharmacies to potentially behave like manufacturers without the oversight of the FDA."
The bill does not specifically address one concern of health system and hospital pharmacies. That is, they want to maintain their status as state-regulated traditional compounders, with the freedom to prepare medicines and nutritional supplements for both individual patients and in larger quantities for anticipated needs based on historical demand, without the additional federal regulatory burden imposed on outsourcing facilities.
The Senate's original version of the compounding legislation issued last May contained clear language granting them that status, but it is not included in the new Senate-House bill.
The central thrust of the new bill is ensuring medication safety. Lawmakers want to avoid another public health disaster like last fall's meningitis crisis, which ultimately claimed 64 lives among 760 individuals with confirmed fungal infections attributed to contaminated methylprednisolone injections made by the now-shuttered New England Compounding Center. Stepped-up inspections by the FDA and state pharmacy boards over the last year have uncovered many more instances of pharmacies in violation of sterility standards, most of them larger compounders that make and distribute products to doctors' offices, health systems and hospitals across the country.
Under the new bill, pharmacies would be prevented from compounding complex, difficult-to-manufacture products. The new bill doesn't specify which products, but the original House version issued earlier this month cited examples such as biologic drugs, metered dose inhalers, transdermal patches and sterile liposomal products.
The new bill also requires that any pharmacy compounding a drug subject to a risk evaluation and mitigation strategy (REMS) would have to demonstrate prior to compounding that the pharmacist or physician is using controls comparable to those applicable under the REMS.
It would also prevent compounders from making copycat versions of patented and approved drugs, but would grant leeway for drugs in short supply.
The National Community Pharmacists Associating strongly endorsed the bill. "This compromise legislation appropriately addresses the issues that led to the NECC tragedy, protects the physician-patient-pharmacist relationship, maintains critical patient access to compounded medications, and strengthens the pharmaceutical supply chain," said R. Douglas Hoey, RPh, MBA, chief executive officer of NCPA.
Not everyone expressed support for the new bill, which now goes to the Senate for a vote. Michael A. Carome, MD, deputy director of Public Citizen's Health Research Group, said the bill would "make it easier for companies like the NECC to manufacture substandard drugs like the one that caused the outbreak" without FDA approval "under the guise of pharmacy compounding." Dr. Carome said the agency already has the authority to take action against pharmacies "that engage in illegal compounding, but the agency has failed to fully exercise this authority."
He also said the creation of the new category of outsourcing pharmacies would allow companies, registering under this designation, to "mass-produce standardized drug products without seeking FDA premarket approval, particularly during drug shortages. This kind of large-scale production is not compounding, it is manufacturing."
http://www.pharmacypracticenews.com/ViewArticle.aspx?d=Policy&d_id=51&i=September+2013&i_id=992&a_id=24156
Global Penicillin Shortage Reduces Rheumatic Fever Treatment Rates
Penicillin is one of the most popular antibiotics that doctors use when treating bacterial infections, such as ear infections or strep throat. Even though this drug might be easily accessible in first world countries, a new report found that in other regions of the world, there is a penicillin shortage.
According to this report, due to the global fight against HIV/AIDS, getting antiretroviral therapy for HIV/AIDS in certain parts of the world is easier than getting penicillin to treat for rheumatic fever.
The global team of rheumatologists revealed that over 15 million people in the world suffer from rheumatic fever with at least 233,000 deaths per year. Rheumatic fever is an inflammatory disease that can manifest after the body has been infected with group A Streptococcus bacteria. When left untreated, rheumatic fever can negatively affect the heart, joints, skin and brain. The scientists of the report stated that fewer than 20 percent of people who need penicillin to treat their rheumatic fever actually get them. On the other hand, 30 percent of the 35 million people infected with HIV receive medical treatment.
"Considerable effort goes into purchasing, procuring and supplying antiretroviral drugs for HIC," commented co-author Dr. Rosemary Wyber from the University of Western Australia reported by NPR.
Due to the focus on HIV/AIDS, clinics often do not have penicillin to treat people with rheumatic fever. If clinics do carry some treatment option, Wyber explained that they are usually of poor quality. The authors stressed that the penicillin shortage must be addressed. People who get rheumatic fever are more likely to get it again. In order to reduce their risk, giving them a slow-release antibiotic, such as benzathine penicillin, is highly effective.
"There's been a lot of penicillin made in unregulated drug labs around the world, and its purity has been in question," Kathryn Taubert of the World Heart Federation. "We need to get more manufacturers to make high-quality penicillin."
Based on the findings from a recent survey of 24 countries, researchers found that 40 percent of health care facilities reported having difficulty getting access to benzathine penicillin supplies. Around 10 percent reported the drug's quality was questionable. The importance of getting hands on this relatively cheap drug needs to be addressed.
http://www.counselheal.com/articles/6895/20130927/global-penicillin-shortage-reduces-rheumatic-fever-treatment-rates.htm
According to this report, due to the global fight against HIV/AIDS, getting antiretroviral therapy for HIV/AIDS in certain parts of the world is easier than getting penicillin to treat for rheumatic fever.
The global team of rheumatologists revealed that over 15 million people in the world suffer from rheumatic fever with at least 233,000 deaths per year. Rheumatic fever is an inflammatory disease that can manifest after the body has been infected with group A Streptococcus bacteria. When left untreated, rheumatic fever can negatively affect the heart, joints, skin and brain. The scientists of the report stated that fewer than 20 percent of people who need penicillin to treat their rheumatic fever actually get them. On the other hand, 30 percent of the 35 million people infected with HIV receive medical treatment.
"Considerable effort goes into purchasing, procuring and supplying antiretroviral drugs for HIC," commented co-author Dr. Rosemary Wyber from the University of Western Australia reported by NPR.
Due to the focus on HIV/AIDS, clinics often do not have penicillin to treat people with rheumatic fever. If clinics do carry some treatment option, Wyber explained that they are usually of poor quality. The authors stressed that the penicillin shortage must be addressed. People who get rheumatic fever are more likely to get it again. In order to reduce their risk, giving them a slow-release antibiotic, such as benzathine penicillin, is highly effective.
"There's been a lot of penicillin made in unregulated drug labs around the world, and its purity has been in question," Kathryn Taubert of the World Heart Federation. "We need to get more manufacturers to make high-quality penicillin."
Based on the findings from a recent survey of 24 countries, researchers found that 40 percent of health care facilities reported having difficulty getting access to benzathine penicillin supplies. Around 10 percent reported the drug's quality was questionable. The importance of getting hands on this relatively cheap drug needs to be addressed.
http://www.counselheal.com/articles/6895/20130927/global-penicillin-shortage-reduces-rheumatic-fever-treatment-rates.htm
Tennessee moves to single-drug executions despite pentobarbital shortage
The state will use the single-drug lethal injection method instead of the three-drug method it has used in the past, according to Tennessee Department of Correction spokeswoman Dorinda Carter.
"The Department of Correction had been unable to obtain the chemicals necessary to carry out an execution since 2011 due to a widespread shortage" of sodium thiopental, a drug used in the three-drug method, Carter said.
Sodium thiopental puts the prisoner to sleep, with another drug administered to paralyze the prisoner and a third to stop the heart.
In April 2011, Tennessee was among the states that turned over its supplies of sodium thiopental to authorities after concerns arose about how the supply of the drug was imported.
That move came after the company that produced sodium thiopental had bowed to European Union pressure to stop making the drug, creating a shortage. The death penalty has been abolished in all EU nations.
The sodium thiopental shortage forced U.S. states to switch to pentobarbital.
Seven states currently use pentobarbital alone for executions and more are planning to use it, according to Richard Dieter, executive director of the Death Penalty Information Center, a non-profit organization that provides information on capital punishment. Other states use it as part of the three-stage execution process.
Pentobarbital also is commonly used during surgeries and by veterinarians to euthanize animals.
"Given it's used by veterinarians and on humans for other purposes, there's probably a lot out there. But if you have to make a new order, it's hard to get for prisons," Dieter said.
Danish manufacturer Lundbeck and its American subsidiary, Akorn, are controlling the distribution of pentobarbital "and are not allowing its distribution if it is to be used for executions," Dieter said.
Dieter said some states that had been using pentobarbital were having to switch to other drugs or find new sources because of the shortage.
"Everybody that used (sodium thiopental) has switched and now they may have to switch again (from pentobarbital)," Dieter said.
http://www.reuters.com/article/2013/09/28/us-usa-execution-tennessee-idUSBRE98R01720130928
"The Department of Correction had been unable to obtain the chemicals necessary to carry out an execution since 2011 due to a widespread shortage" of sodium thiopental, a drug used in the three-drug method, Carter said.
Sodium thiopental puts the prisoner to sleep, with another drug administered to paralyze the prisoner and a third to stop the heart.
In April 2011, Tennessee was among the states that turned over its supplies of sodium thiopental to authorities after concerns arose about how the supply of the drug was imported.
That move came after the company that produced sodium thiopental had bowed to European Union pressure to stop making the drug, creating a shortage. The death penalty has been abolished in all EU nations.
The sodium thiopental shortage forced U.S. states to switch to pentobarbital.
Seven states currently use pentobarbital alone for executions and more are planning to use it, according to Richard Dieter, executive director of the Death Penalty Information Center, a non-profit organization that provides information on capital punishment. Other states use it as part of the three-stage execution process.
Pentobarbital also is commonly used during surgeries and by veterinarians to euthanize animals.
"Given it's used by veterinarians and on humans for other purposes, there's probably a lot out there. But if you have to make a new order, it's hard to get for prisons," Dieter said.
Danish manufacturer Lundbeck and its American subsidiary, Akorn, are controlling the distribution of pentobarbital "and are not allowing its distribution if it is to be used for executions," Dieter said.
Dieter said some states that had been using pentobarbital were having to switch to other drugs or find new sources because of the shortage.
"Everybody that used (sodium thiopental) has switched and now they may have to switch again (from pentobarbital)," Dieter said.
http://www.reuters.com/article/2013/09/28/us-usa-execution-tennessee-idUSBRE98R01720130928
NCPA Urges Passage of Compounding Reform, Drug Security Bill
The National Community Pharmacists Association (NCPA) today endorsed The Drug Quality and Security Act in letters to House and Senate leaders urging approval of the measure.
The bill has two major provisions. First, it would preserve patient access to customized medications prepared by independent community pharmacies while taking steps to enhance protections against a recurrence of the meningitis outbreak linked to the New England Compounding Center (NECC) and exacerbated by the lack of oversight by the Food and Drug Administration (FDA) and Massachusetts state health officials. Second, it would establish a uniform standard for securing the nation's pharmaceutical supply chain.
The legislation would accomplish both goals by preserving current law and creating a voluntary "outsourcing facility" registration, and reflects a bipartisan, House and Senate agreement announced earlier this week by U.S. House Energy & Commerce Committee Chair Fred Upton (R-Mich.) and Ranking Member Henry Waxman (D-Calif.) and U.S. Senate Health, Education, Labor and Pensions Committee Chair Tom Harkin (D-Iowa) and Ranking Member Lamar Alexander (R-Tenn.). The efforts of Reps. Morgan Griffith (R-Va.), Gene Green (D-Texas), Diana DeGette (D-Colo.), and Sen. Pat Roberts (R-Kan.) also proved critical to reaching a final compromise.
"This compromise proposal provides a balanced and effective approach to address critical and complex issues surrounding compounded medications, as well as strengthening our nation's pharmaceutical supply chain," NCPA CEO B. Douglas Hoey, RPh, MBA wrote in his letter to lawmakers. "When off-the-shelf manufactured drugs are not an option, community pharmacists prepare or compound customized medications for individual patients. NCPA commends Congress for crafting bipartisan legislation that addresses the New England Compounding Center (NECC) tragedy, ensures quality standards for all compounded pharmaceuticals, and maintains patient access to vital compounded medications."
Throughout the process, NCPA was heavily engaged in advocating for common-sense solutions that promoted safety, preserved access for patients, and protected small business community pharmacies from burdensome, unfunded mandates. Some of those efforts were highly visible such as when a NCPA official and a NCPA member and pharmacy owner delivered expert testimony before Congressional hearings or when NCPA articulated these views in the media. In other instances, NCPA members and staff lent their expertise and technical advice through countless meetings and other interactions with policymakers.
As a result, in The Drug Quality and Security Act, Congress developed balanced legislation to address critical needs while avoiding provisions in previous legislation that, while well-intended, was problematic for community pharmacists.
"Independent pharmacies have a long and successful history of protecting patient safety while preserving patient access to vital medications," Hoey concluded. "This compromise legislation appropriately addresses the issues that led to the NECC tragedy, protects the physician-patient-pharmacist relationship, maintains critical patient access to compounded medications, and strengthens the pharmaceutical supply chain."
http://www.sacbee.com/2013/09/27/5773891/ncpa-urges-passage-of-compounding.html
The bill has two major provisions. First, it would preserve patient access to customized medications prepared by independent community pharmacies while taking steps to enhance protections against a recurrence of the meningitis outbreak linked to the New England Compounding Center (NECC) and exacerbated by the lack of oversight by the Food and Drug Administration (FDA) and Massachusetts state health officials. Second, it would establish a uniform standard for securing the nation's pharmaceutical supply chain.
The legislation would accomplish both goals by preserving current law and creating a voluntary "outsourcing facility" registration, and reflects a bipartisan, House and Senate agreement announced earlier this week by U.S. House Energy & Commerce Committee Chair Fred Upton (R-Mich.) and Ranking Member Henry Waxman (D-Calif.) and U.S. Senate Health, Education, Labor and Pensions Committee Chair Tom Harkin (D-Iowa) and Ranking Member Lamar Alexander (R-Tenn.). The efforts of Reps. Morgan Griffith (R-Va.), Gene Green (D-Texas), Diana DeGette (D-Colo.), and Sen. Pat Roberts (R-Kan.) also proved critical to reaching a final compromise.
"This compromise proposal provides a balanced and effective approach to address critical and complex issues surrounding compounded medications, as well as strengthening our nation's pharmaceutical supply chain," NCPA CEO B. Douglas Hoey, RPh, MBA wrote in his letter to lawmakers. "When off-the-shelf manufactured drugs are not an option, community pharmacists prepare or compound customized medications for individual patients. NCPA commends Congress for crafting bipartisan legislation that addresses the New England Compounding Center (NECC) tragedy, ensures quality standards for all compounded pharmaceuticals, and maintains patient access to vital compounded medications."
Throughout the process, NCPA was heavily engaged in advocating for common-sense solutions that promoted safety, preserved access for patients, and protected small business community pharmacies from burdensome, unfunded mandates. Some of those efforts were highly visible such as when a NCPA official and a NCPA member and pharmacy owner delivered expert testimony before Congressional hearings or when NCPA articulated these views in the media. In other instances, NCPA members and staff lent their expertise and technical advice through countless meetings and other interactions with policymakers.
As a result, in The Drug Quality and Security Act, Congress developed balanced legislation to address critical needs while avoiding provisions in previous legislation that, while well-intended, was problematic for community pharmacists.
"Independent pharmacies have a long and successful history of protecting patient safety while preserving patient access to vital medications," Hoey concluded. "This compromise legislation appropriately addresses the issues that led to the NECC tragedy, protects the physician-patient-pharmacist relationship, maintains critical patient access to compounded medications, and strengthens the pharmaceutical supply chain."
http://www.sacbee.com/2013/09/27/5773891/ncpa-urges-passage-of-compounding.html
IACP: Compromise Compounding Bill Will Not Advance Quality, Safety
WASHINGTON — The International Academy of Compounding Pharmacists (IACP) believes that the compromise compounding bill that has emerged from Congress will not protect the American public; contains significant gaps because it does not provide key definitions to govern compounding practice; and does not take into account any of the input from the compounding profession provided to Congress over the last year.
“This bill, in its failure to recognize the very real problems in the draft legislation that we have identified over many meetings, will without question result in patients’ inability to obtain access to needed medications,” said David G. Miller, R.Ph, Executive Vice President and CEO of the International Academy of Compounding Pharmacists. “This bill will not further the safety of compounded medication, which was its only purpose.”
Below are some of the serious concerns that IACP has with the bill:
The current bill does not recognize the need for “office use” for patients that have an emergent and vital need for medical treatment by physicians who have long relied upon having these drugs available, such as a patient at risk of vision loss if not treated immediately.
Anticipatory compounding, the practice of making medication available in adequate supply ahead of expected needs (such as a compounder preparing a batch of poison ivy cream at the beginning of summer) is not defined or provided for in this bill.
While the bill creates a new category of outsourcing facilities, which we have previously supported, it does not adequately define these entities, which will lead to more confusion about federal authority and legal challenges.
Although states have long had sufficient authority to regulate compounding, the bill grants the FDA sweeping, unprecedented authority in determining what pharmacies can compound.
“IACP has made every effort and done its due diligence in working on a regular basis with House and Senate staff members and with the FDA, and thus it is unfortunate that the very businesses that help your local communities – through health care, employment and serving patient and practitioner needs – are being ignored in this ‘compromise,’” said Wade Siefert, RPh, President of IACP. “For these reasons, IACP regretfully must strongly oppose this bill.”
http://www.heraldonline.com/2013/09/27/5252349/iacp-compromise-compounding-bill.html
“This bill, in its failure to recognize the very real problems in the draft legislation that we have identified over many meetings, will without question result in patients’ inability to obtain access to needed medications,” said David G. Miller, R.Ph, Executive Vice President and CEO of the International Academy of Compounding Pharmacists. “This bill will not further the safety of compounded medication, which was its only purpose.”
Below are some of the serious concerns that IACP has with the bill:
The current bill does not recognize the need for “office use” for patients that have an emergent and vital need for medical treatment by physicians who have long relied upon having these drugs available, such as a patient at risk of vision loss if not treated immediately.
Anticipatory compounding, the practice of making medication available in adequate supply ahead of expected needs (such as a compounder preparing a batch of poison ivy cream at the beginning of summer) is not defined or provided for in this bill.
While the bill creates a new category of outsourcing facilities, which we have previously supported, it does not adequately define these entities, which will lead to more confusion about federal authority and legal challenges.
Although states have long had sufficient authority to regulate compounding, the bill grants the FDA sweeping, unprecedented authority in determining what pharmacies can compound.
“IACP has made every effort and done its due diligence in working on a regular basis with House and Senate staff members and with the FDA, and thus it is unfortunate that the very businesses that help your local communities – through health care, employment and serving patient and practitioner needs – are being ignored in this ‘compromise,’” said Wade Siefert, RPh, President of IACP. “For these reasons, IACP regretfully must strongly oppose this bill.”
http://www.heraldonline.com/2013/09/27/5252349/iacp-compromise-compounding-bill.html
Friday, September 27, 2013
A Penicillin Shortage Hinders Treatment For Rheumatic Fever
We often take antibiotics for granted. If you catch strep throat, a round of penicillin can clear it up in a few days.
But because of a curious drug shortage, in many parts of the world it’s now easier to get HIV drugs than an old-fashioned form of penicillin that prevents heart damage from rheumatic fever.
Fewer than 20 percent of people who need cheap penicillin shots for rheumatic fever are receiving them, scientists say. In contrast, nearly 30 percent of the 35 million people with HIV are on treatment.
More than 15 million people worldwide have rheumatic fever, an international team of rheumatologists wrote in the journal Global Health. The disease kills at least 233,000 people annually. Kids are often hit the hardest.
“Considerable effort goes into purchasing, procuring and supplying anti-retroviral drugs for HIV,” says Dr. Rosemary Wyber of the University of Western Australia, who co-authored the commentary. By comparison, stocking clinics with the most effective antibiotic for rheumatic fever tends to be ad hoc. That leaves many places with no drugs at all or ones of poor quality, she says.
Rheumatic fever is rare in the U.S. But most of us are well acquainted with the culprit. It’s the same critter that causes strep throat: the bacterium Streptococcus.
Left untreated, a strep infection can trigger a dangerous autoimmune disease.
“They say that rheumatic fever bites at the heart and licks at the joints,” says Dr. Edward Kaplan, of the University of Minnesota, who co-authored the commentary. “There is a painful arthritis that goes with it. But it’s not chronic. The heart damage can be.”
People who get rheumatic fever are at a much higher risk of getting it again. So doctors give patients a slow-release antibiotic that stops flare-ups. The go-to drug for that is benzathine penicillin, a formulation of the antibiotic invented in back in the ‘50s.
Here’s the problem. Thanks to the development of new antibiotics — and the decline of other infectious diseases treated with benzathine penicillin — the world’s supply of the medicine has dwindled
A recent survey of 24 countries found that about 40 percent of health care facilities were having problems maintaining their benzathine penicillin supplies. About 10 percent of them complained that the drug’s quality was shoddy.
“There’s been a lot of penicillin made in unregulated drug labs around the world, and its purity has been in question,” Kathryn Taubert of the World Heart Federation, tells Shots. “We need to get more manufacturers to make high-quality penicillin.”
If Pepsi and Coca-Cola can get soda to rural Mozambique, Taubert says, we should also be able to get penicillin there, too.
http://www.opb.org/news/article/npr-a-penicillin-shortage-hinders-treatment-for-rheumatic-fever/
But because of a curious drug shortage, in many parts of the world it’s now easier to get HIV drugs than an old-fashioned form of penicillin that prevents heart damage from rheumatic fever.
Fewer than 20 percent of people who need cheap penicillin shots for rheumatic fever are receiving them, scientists say. In contrast, nearly 30 percent of the 35 million people with HIV are on treatment.
More than 15 million people worldwide have rheumatic fever, an international team of rheumatologists wrote in the journal Global Health. The disease kills at least 233,000 people annually. Kids are often hit the hardest.
“Considerable effort goes into purchasing, procuring and supplying anti-retroviral drugs for HIV,” says Dr. Rosemary Wyber of the University of Western Australia, who co-authored the commentary. By comparison, stocking clinics with the most effective antibiotic for rheumatic fever tends to be ad hoc. That leaves many places with no drugs at all or ones of poor quality, she says.
Rheumatic fever is rare in the U.S. But most of us are well acquainted with the culprit. It’s the same critter that causes strep throat: the bacterium Streptococcus.
Left untreated, a strep infection can trigger a dangerous autoimmune disease.
“They say that rheumatic fever bites at the heart and licks at the joints,” says Dr. Edward Kaplan, of the University of Minnesota, who co-authored the commentary. “There is a painful arthritis that goes with it. But it’s not chronic. The heart damage can be.”
People who get rheumatic fever are at a much higher risk of getting it again. So doctors give patients a slow-release antibiotic that stops flare-ups. The go-to drug for that is benzathine penicillin, a formulation of the antibiotic invented in back in the ‘50s.
Here’s the problem. Thanks to the development of new antibiotics — and the decline of other infectious diseases treated with benzathine penicillin — the world’s supply of the medicine has dwindled
A recent survey of 24 countries found that about 40 percent of health care facilities were having problems maintaining their benzathine penicillin supplies. About 10 percent of them complained that the drug’s quality was shoddy.
“There’s been a lot of penicillin made in unregulated drug labs around the world, and its purity has been in question,” Kathryn Taubert of the World Heart Federation, tells Shots. “We need to get more manufacturers to make high-quality penicillin.”
If Pepsi and Coca-Cola can get soda to rural Mozambique, Taubert says, we should also be able to get penicillin there, too.
http://www.opb.org/news/article/npr-a-penicillin-shortage-hinders-treatment-for-rheumatic-fever/
Bill would regulate large-scale compounding pharmacies
A bipartisan group of federal lawmakers has unveiled a pharmacy bill in response to a yearlong meningitis outbreak that has killed 64 patients throughout the United States.
The legislation, called the Drug Quality and Security Act, would clarify the U.S. Food and Drug Administration’s authority to regulate the practice of pharmacy compounding and establish a nationwide system to track and trace prescription drugs along the pharmaceutical supply chain, proponents said.
Compounding is the traditional pharmacy practice of mixing medications from scratch to meet the medical needs of individual patients. But compounding pharmacists, who now are regulated by state boards of pharmacy, do not have to adhere to the same safety and quality standards that large pharmaceutical manufacturers must meet.
A large batch of contaminated steroid medicine used in spinal injections, produced last year at a Massachusetts compounding pharmacy, sickened more than 700 patients in 20 states, prompting renewed congressional efforts to strengthen safeguards.
The Kansas City Star first reported such concerns in a series more than a decade ago.
The legislation, unveiled Wednesday night, would create a category of large-scale drug producers, called “outsourcing facilities,” that would have to meet safety standards set by the FDA. Traditional compounders would continue to be regulated by state boards.
U.S. Sen. Pat Roberts of Kansas, who has worked to improve pharmacy safety since the Robert Courtney drug-dilution scandal in 2001, said the bill strikes the right balance between federal regulation and state oversight of small compounders.
“This legislation protects traditional pharmacy while giving patients more confidence in the quality and safety of their compounded drugs,” Roberts, a Republican, said in a written statement.
Allan Coukell, senior director for drug and medical devices for the Pew Charitable Trusts, said his group supported the bill, which he described in a letter to Congress on Thursday as “a major advance for the security of U.S. drug distribution and a step toward regulatory clarity and higher quality standards for compounded medicines.”
The largest trade group representing compounders, the International Academy of Compounding Pharmacists, reacted with caution in an online statement to its members.
“IACP is meeting with (Capitol) Hill staff today to communicate our many concerns with this compromise bill,” the statement read. http://www.kansascity.com/2013/09/26/4509659/bill-would-regulate-large-scale.html
Compounding is the traditional pharmacy practice of mixing medications from scratch to meet the medical needs of individual patients. But compounding pharmacists, who now are regulated by state boards of pharmacy, do not have to adhere to the same safety and quality standards that large pharmaceutical manufacturers must meet.
A large batch of contaminated steroid medicine used in spinal injections, produced last year at a Massachusetts compounding pharmacy, sickened more than 700 patients in 20 states, prompting renewed congressional efforts to strengthen safeguards.
The Kansas City Star first reported such concerns in a series more than a decade ago.
The legislation, unveiled Wednesday night, would create a category of large-scale drug producers, called “outsourcing facilities,” that would have to meet safety standards set by the FDA. Traditional compounders would continue to be regulated by state boards.
U.S. Sen. Pat Roberts of Kansas, who has worked to improve pharmacy safety since the Robert Courtney drug-dilution scandal in 2001, said the bill strikes the right balance between federal regulation and state oversight of small compounders.
“This legislation protects traditional pharmacy while giving patients more confidence in the quality and safety of their compounded drugs,” Roberts, a Republican, said in a written statement.
Allan Coukell, senior director for drug and medical devices for the Pew Charitable Trusts, said his group supported the bill, which he described in a letter to Congress on Thursday as “a major advance for the security of U.S. drug distribution and a step toward regulatory clarity and higher quality standards for compounded medicines.”
The largest trade group representing compounders, the International Academy of Compounding Pharmacists, reacted with caution in an online statement to its members.
“IACP is meeting with (Capitol) Hill staff today to communicate our many concerns with this compromise bill,” the statement read. http://www.kansascity.com/2013/09/26/4509659/bill-would-regulate-large-scale.html
Bill makes compounders' participation in oversight voluntary
A bipartisan bill in Congress aimed at strengthening oversight of compounding pharmacies and preventing harm to patients would make drug compounders' participation in a new regulatory category voluntary rather than mandatory, a significant change from previous bills addressing the issue.
The bill is a response to the quality lapses such as the recent multistate outbreak of meningitis caused by contaminated vials of steroid injections, involving more than 60 deaths. But it's not clear whether the voluntary provision will gain the support of provider and patient safety groups.
http://www.modernhealthcare.com/article/20130926/NEWS/309269944/bill-makes-compounders-participation-in-oversight-voluntary
The bill is a response to the quality lapses such as the recent multistate outbreak of meningitis caused by contaminated vials of steroid injections, involving more than 60 deaths. But it's not clear whether the voluntary provision will gain the support of provider and patient safety groups.
The bicameral Drug Quality and Safety Act, announced Wednesday night, would allow compounders that mix sterile drugs without a prescription and ship across state lines to choose whether to register as outsourcing facilities. Those pharmacies then would be regulated by the Food and Drug Administration rather than by state boards of pharmacy. It also seeks to clarify the FDA's oversight role, permitting the agency to follow a national standard while regulating facilities making adulterated, misbranded or unapproved products and allowing the FDA to establish a list of drugs that may not be compounded for safety reasons. In addition, the bill also mandates the formation of a national drug-tracking system.
“This legislation will improve the safety of compounded drugs by clarifying the oversight responsibilities of the FDA over large-volume compounders and by holding facilities to high quality standards,” said Senate HELP Committee Chairman Tom Harkin (D-Iowa) in a written statement.
But some patient safety advocates expressed reservations about the bill.
“Because it's voluntary, it's not going to create a sweeping change immediately in how these facilities operate,” said Allan Coukell, senior director of drugs and medical devices for the Pew Charitable Trusts, which supports the bill but not the voluntary provision.
What the bill is likely to do is create a market where hospitals and clinics choose to buy drugs from registered compounders because they would be expected to have higher quality standards, Coukell said. “Many compounders may continue to produce large volumes of sterile products primarily under state oversight, which is highly variable,” she wrote in a Sept. 26 letter to lawmakers.
The practice of drug compounding has received intense scrutiny in the year since a multistate meningitis outbreak was first reported. More than 60 people have died and another 750 were sickened from the contaminated injections.
The New England Compounding Center, the Framingham, Mass.-based compounding pharmacy that mixed and distributed the contaminated drugs, is now in bankruptcy protection and is facing hundreds of lawsuits. In the year since the outbreak was first reported, lawmakers and patient groups have called for a new regulatory framework that would put oversight of large, high-risk compounders under the purview of the FDA.
Congress had been grappling over how best to define this class of compounders, many of which ship thousands of drugs to multiple states. Issues included where to draw lines between state and federal authorities and how to balance questions about patient access to medications against the safety of compounded drugs.
In an e-mail, a spokeswoman for the American Hospital Association, which had supported the earlier Senate bill, said: “We are still talking with our members and we are discussing the bill and have questions that we will work with Congress on but we support the goal of the bill and are hopeful a good bill can pass.”
“This legislation will improve the safety of compounded drugs by clarifying the oversight responsibilities of the FDA over large-volume compounders and by holding facilities to high quality standards,” said Senate HELP Committee Chairman Tom Harkin (D-Iowa) in a written statement.
But some patient safety advocates expressed reservations about the bill.
“Because it's voluntary, it's not going to create a sweeping change immediately in how these facilities operate,” said Allan Coukell, senior director of drugs and medical devices for the Pew Charitable Trusts, which supports the bill but not the voluntary provision.
What the bill is likely to do is create a market where hospitals and clinics choose to buy drugs from registered compounders because they would be expected to have higher quality standards, Coukell said. “Many compounders may continue to produce large volumes of sterile products primarily under state oversight, which is highly variable,” she wrote in a Sept. 26 letter to lawmakers.
The practice of drug compounding has received intense scrutiny in the year since a multistate meningitis outbreak was first reported. More than 60 people have died and another 750 were sickened from the contaminated injections.
The New England Compounding Center, the Framingham, Mass.-based compounding pharmacy that mixed and distributed the contaminated drugs, is now in bankruptcy protection and is facing hundreds of lawsuits. In the year since the outbreak was first reported, lawmakers and patient groups have called for a new regulatory framework that would put oversight of large, high-risk compounders under the purview of the FDA.
Congress had been grappling over how best to define this class of compounders, many of which ship thousands of drugs to multiple states. Issues included where to draw lines between state and federal authorities and how to balance questions about patient access to medications against the safety of compounded drugs.
In an e-mail, a spokeswoman for the American Hospital Association, which had supported the earlier Senate bill, said: “We are still talking with our members and we are discussing the bill and have questions that we will work with Congress on but we support the goal of the bill and are hopeful a good bill can pass.”
http://www.modernhealthcare.com/article/20130926/NEWS/309269944/bill-makes-compounders-participation-in-oversight-voluntary
Congressional panels agree on bill to regulate drug compounding
House and Senate committees have agreed on legislation that would give the FDA greater authority to regulate companies that compound sterile drugs and ship them across state lines.
The legislation would also create a national set of standards to track pharmaceuticals through the distribution chain to help thwart the introduction of fake medication into the drug supply.
The bill, called the Drug Quality and Security Act, comes in response to a deadly outbreak last year of fungal meningitis that killed more than 50 people and was traced to a tainted steroid sold by the New England Compounding Center in Framingham, Mass.
The legislation is expected to pass quickly through the full House and Senate.
Traditionally, pharmacists who compound medication mix tailored doses for individual patients in response to specific prescriptions. Over the last decade the practice has mushroomed, with some pharmacies selling thousands of doses of regularly used mixtures without prescriptions for physicians to keep for future use.
The legislation would draw a distinction between traditional compounding pharmacies and those such as NECC that ship sterile products across state lines. These larger organizations, to be known as "outsourcing facilities," would be regulated by the FDA but be exempt from the full spectrum of regulations that apply to traditional pharmaceutical companies.
Traditional compounding pharmacies would continue to be regulated by state boards of pharmacy.
Previous attempts to create national standards to track and trace drugs have foundered amid complaints from companies that they would be too costly to implement.
But concerns over counterfeit drugs have been growing. Last year, fake vials of Roche Holding AG's cancer drug Avastin appeared in the United States from Britain where it was purchased from a Turkish wholesaler.
The World Health Organization estimates that less than 1 percent of medicines available in the developed world are likely to be counterfeit. Globally, that number is around 10 percent.
In the United States, dozens of states have some type of regulation designed to track a drug's pedigree, but the rules are inconsistent. The bill is designed to resolve the current patchwork of federal regulation by applying a uniform standard nationwide.
http://www.nbcnews.com/health/congressional-panels-agree-bill-regulate-drug-compounding-8C11264610
The legislation would also create a national set of standards to track pharmaceuticals through the distribution chain to help thwart the introduction of fake medication into the drug supply.
The bill, called the Drug Quality and Security Act, comes in response to a deadly outbreak last year of fungal meningitis that killed more than 50 people and was traced to a tainted steroid sold by the New England Compounding Center in Framingham, Mass.
The legislation is expected to pass quickly through the full House and Senate.
Traditionally, pharmacists who compound medication mix tailored doses for individual patients in response to specific prescriptions. Over the last decade the practice has mushroomed, with some pharmacies selling thousands of doses of regularly used mixtures without prescriptions for physicians to keep for future use.
The legislation would draw a distinction between traditional compounding pharmacies and those such as NECC that ship sterile products across state lines. These larger organizations, to be known as "outsourcing facilities," would be regulated by the FDA but be exempt from the full spectrum of regulations that apply to traditional pharmaceutical companies.
Traditional compounding pharmacies would continue to be regulated by state boards of pharmacy.
Previous attempts to create national standards to track and trace drugs have foundered amid complaints from companies that they would be too costly to implement.
But concerns over counterfeit drugs have been growing. Last year, fake vials of Roche Holding AG's cancer drug Avastin appeared in the United States from Britain where it was purchased from a Turkish wholesaler.
The World Health Organization estimates that less than 1 percent of medicines available in the developed world are likely to be counterfeit. Globally, that number is around 10 percent.
In the United States, dozens of states have some type of regulation designed to track a drug's pedigree, but the rules are inconsistent. The bill is designed to resolve the current patchwork of federal regulation by applying a uniform standard nationwide.
http://www.nbcnews.com/health/congressional-panels-agree-bill-regulate-drug-compounding-8C11264610
Drugmakers would get more FDA scrutiny under draft bill
The U.S. for the first time would have uniform regulations to help identify stolen or fake drugs, and makers would get more scrutiny, under a draft bill from the Senate and House committees that oversee pharmaceutical safety.
The measure would let the Food and Drug Administration collect and spend fees to cover costs of inspections and licensing. It also would impose handling and record-keeping requirements and create notification rules for drugs that are potentially unsuitable for distribution.
The measure responds to regulatory gaps revealed by investigations into 50 meningitis-related deaths last year that resulted from tainted medications linked to a compounding pharmacy. It would replace a patchwork of state laws governing distribution of drugs through about 4 billion prescriptions a year filled by compounding and traditional pharmacies, the Senate Health, Education, Labor and Pensions and House Energy and Commerce committees said in a statement.
"This legislation will improve the safety of compounded drugs by clarifying the oversight responsibilities of the FDA over large-volume compounders and by holding facilities to high quality standards," Iowa Democrat Tom Harkin, who heads the Senate committee, said in a statement. "This bill also calls for an unprecedented tracing system that will track prescription drugs from manufacturing to distribution."
Counterfeit Imports
The FDA said last year that it had discovered counterfeit versions of Roche Holding AG's cancer medicine Avastin -- with no active ingredient -- in boxes identifying the contents as Altuzan, Turkey's version of Avastin, which hasn't been approved for use in the U.S. In 2008 the FDA recalled Baxter International Inc.'s blood thinner heparin; during the crisis, neither the FDA nor Baxter was able to re-create the supply chain, taking weeks to get close to the source, according to a report last year by the Institute of Medicine, part of the Washington-based National Academies of Sciences.
Under the proposed legislation, manufacturers, repackagers, wholesale distributors and dispensers would, within seven years, be maintaining and sharing records of key information about each drug's distribution history.
The measure would let drug compounders register as outsourcing facilities subject to the same FDA oversight as traditional pharmacies. That would enable the FDA to identify providers and products, get reports on adverse reactions and make risk-based inspections.
FDA Criticized
The FDA came under criticism from Congress for failing to close New England Compounding Pharmacy Inc. before the company shipped fungus-tainted medications to customers across the U.S. in last year's meningitis outbreak. The company subsequently filed for bankruptcy. The FDA told lawmakers that its legal authority over compounding pharmacies needed to be clarified.
The relevant committee chairmen and the panels' top minority members reached a rare bipartisan accord yesterday after the Republican-controlled House passed a supply-chain bill, H.R. 1919, and the Democratic-majority Senate panel approved compounding pharmacy legislation, S. 959.
Compounding pharmacies prepare personalized prescriptions and are regulated by state health authorities. Some companies also produce larger amounts of blended medicines.
A Senate committee staff report released in May found that in the eight months after the meningitis outbreak caused by contaminated compounded drugs, at least 48 compounding companies were found to be producing and selling drugs contaminated or created in unsafe conditions. In at least three cases, visible contamination was spotted in widely distributed sterile compound drugs.
Documented Deaths
The report also found that according to FDA documents between 2001 and 2011, at least 25 deaths and 36 serious injuries, including hospitalizations, were linked to large-scale drug compounding companies, including 13 deaths in 2011. The figures may understate the actual number of adverse events because current law doesn't require reporting of those events.
A separate account of adverse events and complaints linked to drug compounding companies from 1988 to 2005 showed at least 38 deaths, including six infants or children, and 210 injuries came from drugs that were contaminated, mislabeled or caused lethal overdoses because they contained more of the active pharmaceutical ingredient than indicated.
The Senate report concluded that "to reduce the risk to the public health from compounded drug products, it is essential that a clear statutory framework be enacted -- one that requires compounding manufacturers to engage in good manufacturing practices, to better ensure the drugs produced are sterile and contain the correct amount of the active pharmaceutical ingredient."
http://www.telegram.com/article/20130926/NEWS/309269646/1002/business
The measure would let the Food and Drug Administration collect and spend fees to cover costs of inspections and licensing. It also would impose handling and record-keeping requirements and create notification rules for drugs that are potentially unsuitable for distribution.
The measure responds to regulatory gaps revealed by investigations into 50 meningitis-related deaths last year that resulted from tainted medications linked to a compounding pharmacy. It would replace a patchwork of state laws governing distribution of drugs through about 4 billion prescriptions a year filled by compounding and traditional pharmacies, the Senate Health, Education, Labor and Pensions and House Energy and Commerce committees said in a statement.
"This legislation will improve the safety of compounded drugs by clarifying the oversight responsibilities of the FDA over large-volume compounders and by holding facilities to high quality standards," Iowa Democrat Tom Harkin, who heads the Senate committee, said in a statement. "This bill also calls for an unprecedented tracing system that will track prescription drugs from manufacturing to distribution."
Counterfeit Imports
The FDA said last year that it had discovered counterfeit versions of Roche Holding AG's cancer medicine Avastin -- with no active ingredient -- in boxes identifying the contents as Altuzan, Turkey's version of Avastin, which hasn't been approved for use in the U.S. In 2008 the FDA recalled Baxter International Inc.'s blood thinner heparin; during the crisis, neither the FDA nor Baxter was able to re-create the supply chain, taking weeks to get close to the source, according to a report last year by the Institute of Medicine, part of the Washington-based National Academies of Sciences.
Under the proposed legislation, manufacturers, repackagers, wholesale distributors and dispensers would, within seven years, be maintaining and sharing records of key information about each drug's distribution history.
The measure would let drug compounders register as outsourcing facilities subject to the same FDA oversight as traditional pharmacies. That would enable the FDA to identify providers and products, get reports on adverse reactions and make risk-based inspections.
FDA Criticized
The FDA came under criticism from Congress for failing to close New England Compounding Pharmacy Inc. before the company shipped fungus-tainted medications to customers across the U.S. in last year's meningitis outbreak. The company subsequently filed for bankruptcy. The FDA told lawmakers that its legal authority over compounding pharmacies needed to be clarified.
The relevant committee chairmen and the panels' top minority members reached a rare bipartisan accord yesterday after the Republican-controlled House passed a supply-chain bill, H.R. 1919, and the Democratic-majority Senate panel approved compounding pharmacy legislation, S. 959.
Compounding pharmacies prepare personalized prescriptions and are regulated by state health authorities. Some companies also produce larger amounts of blended medicines.
A Senate committee staff report released in May found that in the eight months after the meningitis outbreak caused by contaminated compounded drugs, at least 48 compounding companies were found to be producing and selling drugs contaminated or created in unsafe conditions. In at least three cases, visible contamination was spotted in widely distributed sterile compound drugs.
Documented Deaths
The report also found that according to FDA documents between 2001 and 2011, at least 25 deaths and 36 serious injuries, including hospitalizations, were linked to large-scale drug compounding companies, including 13 deaths in 2011. The figures may understate the actual number of adverse events because current law doesn't require reporting of those events.
A separate account of adverse events and complaints linked to drug compounding companies from 1988 to 2005 showed at least 38 deaths, including six infants or children, and 210 injuries came from drugs that were contaminated, mislabeled or caused lethal overdoses because they contained more of the active pharmaceutical ingredient than indicated.
The Senate report concluded that "to reduce the risk to the public health from compounded drug products, it is essential that a clear statutory framework be enacted -- one that requires compounding manufacturers to engage in good manufacturing practices, to better ensure the drugs produced are sterile and contain the correct amount of the active pharmaceutical ingredient."
http://www.telegram.com/article/20130926/NEWS/309269646/1002/business
Congress strikes deal to crack down on pharmacies in meningitis scare
WASHINGTON — Leaders of key U.S. Senate and House committees have agreed in principle on legislation to strengthen safeguards on so-called compounding pharmacies in the wake of a meningitis outbreak that killed 19 people in Michigan and injured hundreds of others a year ago.
Earlier this month, the Free Press reported on a House bill being introduced that sought to clarify federal authority over certain pharmaceutical providers and how it differed from the Senate version — potentially setting up a battle between the two chambers.
But in a news release Wednesday, a bipartisan group of leaders from the House Energy and Commerce Committee and the Senate Committee on Health, Education, Labor & Pensions signaled agreement on legislation that “clarifies current federal law regarding pharmacy compounding and resolves the patchwork of current federal regulation.”
Compounding pharmacies — a term traditionally applied to businesses that mix drugs for specific needs of a patient, but more recently applied to larger producers supplying compounds to hospitals and other health care practitioners — came under scrutiny after the meningitis outbreak last fall that affected 750 people nationwide, killing 64.
Linked to fungal contamination of injectable steroids from a Massachusetts center, the outbreak hit hardest in Michigan with 264 total cases. In Congress, the issue has revolved around how best to clarify when a pharmacy falls under Food and Drug Administration purview. States generally have oversight of traditional compounding pharmacies.
Energy and Commerce Committee Chairman Fred Upton, R-St. Joseph, on Thursday called the legislation “a major step forward” toward clarifying federal law. The exact legislative wording, however, was not immediately available for review.
A second part of the bill is expected to replace the various prescription-drug tracing laws at the state level by creating a new uniform framework for tracking drugs from the manufacturer to the pharmacy nationwide.
http://www.freep.com/article/20130926/NEWS06/309260169/1008/news06/Congressional-accord-reached-pharmacy-legislation-wake-meningitis-outbreak
Earlier this month, the Free Press reported on a House bill being introduced that sought to clarify federal authority over certain pharmaceutical providers and how it differed from the Senate version — potentially setting up a battle between the two chambers.
But in a news release Wednesday, a bipartisan group of leaders from the House Energy and Commerce Committee and the Senate Committee on Health, Education, Labor & Pensions signaled agreement on legislation that “clarifies current federal law regarding pharmacy compounding and resolves the patchwork of current federal regulation.”
Compounding pharmacies — a term traditionally applied to businesses that mix drugs for specific needs of a patient, but more recently applied to larger producers supplying compounds to hospitals and other health care practitioners — came under scrutiny after the meningitis outbreak last fall that affected 750 people nationwide, killing 64.
Linked to fungal contamination of injectable steroids from a Massachusetts center, the outbreak hit hardest in Michigan with 264 total cases. In Congress, the issue has revolved around how best to clarify when a pharmacy falls under Food and Drug Administration purview. States generally have oversight of traditional compounding pharmacies.
Energy and Commerce Committee Chairman Fred Upton, R-St. Joseph, on Thursday called the legislation “a major step forward” toward clarifying federal law. The exact legislative wording, however, was not immediately available for review.
A second part of the bill is expected to replace the various prescription-drug tracing laws at the state level by creating a new uniform framework for tracking drugs from the manufacturer to the pharmacy nationwide.
http://www.freep.com/article/20130926/NEWS06/309260169/1008/news06/Congressional-accord-reached-pharmacy-legislation-wake-meningitis-outbreak
FDA Inspections Put Compounding Pharmacies In Regulatory Gray Zone
Now, a follow-up on a series we aired earlier this year on drug shortages in hospitals. We called it Critical Supply, and we found that compounding pharmacies help hospitals fill the gap with some chemotherapy treatments, emergency crash-cart injections and even basic vitamins that go in IV fluids.
A compounding pharmacy that served many hospitals in the Carolinas remains shut down months after its state board of pharmacy said it could get back to work. That's because the Food and Drug Administration has effectively kept it shut down. But whether the FDA has the authority to do that is unclear. Today, WFAE’s Michael Tomsic reports on the challenges of meeting the FDA’s standards.
From the front, Medi-Fare Drug Center in Blacksburg, SC, looks like your traditional mom-and-pop, small-town pharmacy. Owner Pat Stephens even works the cash register on occasion
"Six, seven, eight, nine, ten, and ten is $20," Stephens said as she gave change to a young man who bought an ointment to treat poison ivy about two months ago.
But in the back of Medi-Fare, it’s a different world.
Air roars through the clean room. This is where technicians are supposed to mix and customize prescription drug cocktails that aren’t commercially available.
It was a test day for a new air filtration system in mid August. The air has to flow to a certain way to meet FDA standards. Jesse Gillikin is a consultant working with Medi-Fare.
"We're preparing to do some smoke testing over the newly installed HEPA filters," Gillikin said.
Gillikin broke a glass vial, and white smoke began pouring out. He held it near the vents, which pushed the smoke straight down over the area where technicians will compound. The idea is to have clean air flowing over a drug mix.
"You can see that the smoke is getting below where the top of the tables would be," Gillikin said. "I think the tables are 40 inches. It's a big improvement from the last design."
It’s been a long 9 months for Medi-Fare's owner. FDA inspectors have come several times since December, telling Stephens her clean room isn't up to par. She's trying to comply. And in the meantime, the biggest part of her business is shut down.
"We've laid off 23 people," Stephens said. And that's out of a staff of close to 30.
It's also meant that about two dozen hospitals in the Carolinas are forced to go elsewhere to get some drugs in short supply. That includes hospitals in Carolinas HealthCare System.
But whether the FDA has the authority to effectively shut down Medi-Fare, or other compounders, is unclear. Sheldon Bradshaw was the FDA's chief counsel from 2005 to 2007.
"The FDA has the authority to regulate drug manufacturing," Bradshaw said. "The FDA does not regulate the practice of pharmacy. That's regulated by the states."
Bradshaw said the line between manufacturers and compounding pharmacies used to be clear. Compounders mixed drugs for specific patients in their communities, while manufacturers created drugs in bulk and often shipped them across the country.
But that line blurred as some compounders grew into big businesses.
"They're going out and creating an entire line of drug products," he said. "They're hiring a sales force. They're going out and marketing these products to doctors like a drug manufacturer would."
An example is the compounder in New England linked to a deadly meningitis outbreak that started a year ago. There were hundreds of infections across the country, and more than 60 people died.
In response, the FDA has increased inspections of compounders, arguing they're more like manufacturers. But Bradshaw said that can be a tough argument.
"Where you have a gray area is in these cases where you have a smaller mom and pop pharmacy like the one in South Carolina that’s engaged in some compounding, perhaps even in bulk, in response to a request from a hospital for products that aren't commercially available," he said.
Hospitals have made more of those requests to Medi-Fare and other compounders as drug shortages have intensified in the past few years.
The FDA has inspected about 70 compounding firms in the past year, said Howard Sklamberg, the director of the FDA Office of Compliance. Sklamberg acknowledged the FDA's authority over compounders is unclear. But he said, "We don't send into a firm lawyers with law books."
"We send scientists and trained professionals who know how sterile drugs are supposed to be made," Sklamberg continued. He said inspectors have found startling conditions, like pharmacists using a coffee filter to filter drugs.
"We inspect and we look at the conditions in a firm, then we come back to FDA, and if there's an emergency, we take care of it," he said. "But when we think of using the law, we then consult our lawyers."
So it's inspect first, figure out the law later. Sklamberg said that's the way it has to be because compounders don't have to register with the FDA.
"Until we walk in the door, we may not know what products they're making," he said. "We may not know whether they're getting prescriptions. We may not know the size of their operation. We may not know a whole bunch of facts that would be relevant to what law applies.
At least 19 pharmacies have shut down their compounding operations in the past year, and at least 17 have recalled drugs, according to the FDA.
Very few of the compounders inspected have met the FDA's manufacturer standards. That's no surprise to David Miller, the CEO of the International Academy of Compounding Pharmacists.
"The federal government has changed the rules and inspected with a different rule book, and then told them that they can't do business unless they follow rules that were never designed for a pharmacy in the first place," Miller said.
The manufacturer standards are much stricter and more expensive to meet than state standards governing compounders under current law.
Here's one example: manufacturers have to wear biohazard suits that cover their entire bodies when they're making drugs. Compounders don't, and can leave parts of their face, forehead and neck exposed.
Congress is working on a new law to govern big compounders.
"We want to clarify the FDA's authority in this realm, particularly in regard to compounders who try to pretend that they're not manufacturers," Rep. Morgan Griffith of Virginia said during a hearing this summer. "And that's sometimes difficult, and I understand that."
But until a new law makes the distinction clearer, the FDA has decided that doing nothing isn't an option.
"We're looking to see whether the procedures a firm uses are safe for the products it's making," said Sklamberg, the FDA compliance director. "When products are sterile products that are going to be injected into the human body, they have to be made very carefully because when you inject a bacteria or a fungus into someone's blood stream, they could get sick, they could die."
Back at Medi-Fare, Pat Stephens is aiming to meet the manufacturer standards by mid October.
"This is the choice I've made," she said. "And I'm certainly not going to sit here and tell you that my fellow compounders should follow the same path."
That's because of cost and time. Medi-Fare's consultant says it costs an average facility about $35,000 dollars to comply. And even once Medi-Fare gets there, the FDA hasn't promised Stephens that she'll be able to compound again.
http://wfae.org/post/fda-inspections-put-compounding-pharmacies-regulatory-gray-zone
A compounding pharmacy that served many hospitals in the Carolinas remains shut down months after its state board of pharmacy said it could get back to work. That's because the Food and Drug Administration has effectively kept it shut down. But whether the FDA has the authority to do that is unclear. Today, WFAE’s Michael Tomsic reports on the challenges of meeting the FDA’s standards.
From the front, Medi-Fare Drug Center in Blacksburg, SC, looks like your traditional mom-and-pop, small-town pharmacy. Owner Pat Stephens even works the cash register on occasion
"Six, seven, eight, nine, ten, and ten is $20," Stephens said as she gave change to a young man who bought an ointment to treat poison ivy about two months ago.
But in the back of Medi-Fare, it’s a different world.
Air roars through the clean room. This is where technicians are supposed to mix and customize prescription drug cocktails that aren’t commercially available.
It was a test day for a new air filtration system in mid August. The air has to flow to a certain way to meet FDA standards. Jesse Gillikin is a consultant working with Medi-Fare.
"We're preparing to do some smoke testing over the newly installed HEPA filters," Gillikin said.
Gillikin broke a glass vial, and white smoke began pouring out. He held it near the vents, which pushed the smoke straight down over the area where technicians will compound. The idea is to have clean air flowing over a drug mix.
"You can see that the smoke is getting below where the top of the tables would be," Gillikin said. "I think the tables are 40 inches. It's a big improvement from the last design."
It’s been a long 9 months for Medi-Fare's owner. FDA inspectors have come several times since December, telling Stephens her clean room isn't up to par. She's trying to comply. And in the meantime, the biggest part of her business is shut down.
"We've laid off 23 people," Stephens said. And that's out of a staff of close to 30.
It's also meant that about two dozen hospitals in the Carolinas are forced to go elsewhere to get some drugs in short supply. That includes hospitals in Carolinas HealthCare System.
But whether the FDA has the authority to effectively shut down Medi-Fare, or other compounders, is unclear. Sheldon Bradshaw was the FDA's chief counsel from 2005 to 2007.
"The FDA has the authority to regulate drug manufacturing," Bradshaw said. "The FDA does not regulate the practice of pharmacy. That's regulated by the states."
Bradshaw said the line between manufacturers and compounding pharmacies used to be clear. Compounders mixed drugs for specific patients in their communities, while manufacturers created drugs in bulk and often shipped them across the country.
But that line blurred as some compounders grew into big businesses.
"They're going out and creating an entire line of drug products," he said. "They're hiring a sales force. They're going out and marketing these products to doctors like a drug manufacturer would."
An example is the compounder in New England linked to a deadly meningitis outbreak that started a year ago. There were hundreds of infections across the country, and more than 60 people died.
In response, the FDA has increased inspections of compounders, arguing they're more like manufacturers. But Bradshaw said that can be a tough argument.
"Where you have a gray area is in these cases where you have a smaller mom and pop pharmacy like the one in South Carolina that’s engaged in some compounding, perhaps even in bulk, in response to a request from a hospital for products that aren't commercially available," he said.
Hospitals have made more of those requests to Medi-Fare and other compounders as drug shortages have intensified in the past few years.
The FDA has inspected about 70 compounding firms in the past year, said Howard Sklamberg, the director of the FDA Office of Compliance. Sklamberg acknowledged the FDA's authority over compounders is unclear. But he said, "We don't send into a firm lawyers with law books."
"We send scientists and trained professionals who know how sterile drugs are supposed to be made," Sklamberg continued. He said inspectors have found startling conditions, like pharmacists using a coffee filter to filter drugs.
"We inspect and we look at the conditions in a firm, then we come back to FDA, and if there's an emergency, we take care of it," he said. "But when we think of using the law, we then consult our lawyers."
So it's inspect first, figure out the law later. Sklamberg said that's the way it has to be because compounders don't have to register with the FDA.
"Until we walk in the door, we may not know what products they're making," he said. "We may not know whether they're getting prescriptions. We may not know the size of their operation. We may not know a whole bunch of facts that would be relevant to what law applies.
At least 19 pharmacies have shut down their compounding operations in the past year, and at least 17 have recalled drugs, according to the FDA.
Very few of the compounders inspected have met the FDA's manufacturer standards. That's no surprise to David Miller, the CEO of the International Academy of Compounding Pharmacists.
"The federal government has changed the rules and inspected with a different rule book, and then told them that they can't do business unless they follow rules that were never designed for a pharmacy in the first place," Miller said.
The manufacturer standards are much stricter and more expensive to meet than state standards governing compounders under current law.
Here's one example: manufacturers have to wear biohazard suits that cover their entire bodies when they're making drugs. Compounders don't, and can leave parts of their face, forehead and neck exposed.
Congress is working on a new law to govern big compounders.
"We want to clarify the FDA's authority in this realm, particularly in regard to compounders who try to pretend that they're not manufacturers," Rep. Morgan Griffith of Virginia said during a hearing this summer. "And that's sometimes difficult, and I understand that."
But until a new law makes the distinction clearer, the FDA has decided that doing nothing isn't an option.
"We're looking to see whether the procedures a firm uses are safe for the products it's making," said Sklamberg, the FDA compliance director. "When products are sterile products that are going to be injected into the human body, they have to be made very carefully because when you inject a bacteria or a fungus into someone's blood stream, they could get sick, they could die."
Back at Medi-Fare, Pat Stephens is aiming to meet the manufacturer standards by mid October.
"This is the choice I've made," she said. "And I'm certainly not going to sit here and tell you that my fellow compounders should follow the same path."
That's because of cost and time. Medi-Fare's consultant says it costs an average facility about $35,000 dollars to comply. And even once Medi-Fare gets there, the FDA hasn't promised Stephens that she'll be able to compound again.
http://wfae.org/post/fda-inspections-put-compounding-pharmacies-regulatory-gray-zone
Today's Shortages
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ASHP/FDA
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Aminophylline Injection
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Benztropine Injection
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Chromium (Chromic Chloride)
Injection
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Leuprolide Acetate 14-Day Kit
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Methylene Blue Injection
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Methylprednisolone Acetate
Injection
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Metronidazole Injection
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Pantoprazole Tablets
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Potassium Chloride Injection
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Prednisone Tablets
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Verapamil Injection
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Zinc Injection
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