Bennett Burr Power Grab

When politicians start talking about “bi-partisan cooperation,” smart citizens get nervous. It usually means another transfer of freedom and taxes to the federal government at the expense of individuals, families, localities, and states.

Case in point: a Denver Post op-ed by two U.S. Senators (or their staffs) on their latest “bipartisan” deal. The Senators are Michael Bennett (D.-Colo.) and Richard Burr (R.-N.C.). The op-ed is pure political blather, a haze of almost incomprehensible feel-good rhetoric. But the upshot is this: The two distinguished solons are very proud of themselves for managing yet another transfer of authority from the states to the federal government.

You can read the op-ed here. As you can see, it is filled with mind-deadening phrases refined by pollsters and focus group research: “we have worked with,” “bipartisan,” “ensure the safety,” “stakeholders,” “pragmatism and hard work,”  etc., etc.

As for the law itself, it has the kind of title we have come to expect from Congress in recent years: The Drug Quality and Security Act. (Doesn’t that title make you feel good?) Of course, many of these labels have about as much correspondence to the real world as the “Patient Protection and Affordable Care Act.”

The text of the measure is almost impossible for anyone without legal training to understand. (You can see for yourself here.)  Essentially, however, it transfers to the federal government areas of drug compounding and distribution traditionally controlled by the states. It imposes new obligations, licenses, and/or paperwork on manufacturers, repackagers, wholesalers, and your local pharmacy. It takes major steps toward federal control of our state pharmacy boards, and restricts state regulatory choices in the areas it covers.

The bill is also about revenue: It authorizes the federal government to collect various new “fees.” (I put the word in quotation marks because those “fees” are really taxes.)

Like the op-ed, the text of the law is filled with mind-numbing, and sometimes deceptive, language. Consider this provision:

Nothing in this section shall be construed to preempt State requirements related to the distribution of prescription drugs if such requirements are not related to product tracing as described in subsection (a) or wholesale distributor and third-party logistics provider licensure as described in subsection (b) applicable under section 503(e) (as amended by the Drug Supply Chain Security Act) or this subchapter (or regulations issued thereunder).

At first, you might think the bill leaves state regulations in effect. But look closer: The provision really is about where federal law does preempt: “requirements . . . related to product tracing . . .. [and] wholesale distributor and third-party logistics provider licensure.” Another passage makes it clear that much state flexibility is gone:

Beginning on the date of enactment of the Drug Supply Chain Security Act, no State or political subdivision of a State may establish or continue any standards, requirements, or regulations with respect to wholesale prescription drug distributor or third-party logistics provider licensure that are inconsistent with, less stringent than, directly related to, or covered by the standards and requirements applicable under section 503(e).

The measure does not set forth its constitutional justification. In other words, it does not cite any of Congress’s enumerated powers as the basis for the authority it claims. Occasional mentions of “commerce” suggest that it relies on the Constitution’s much-abused grant of power to “regulate Commerce . . . among the several States.” In fact, however, the bill sweeps deeply into in-state commerce and into activities that really are not “commerce” at all.

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The op-ed touts the bill’s “strong [meaning "intrusive"], uniform” [meaning "centralized"] standards. But the Constitution limited congressional powers precisely to protect us from too many centralized standards.The federalism created by our Constitution  is about local control, responsiveness to local preferences, better government, diversity, and the ability of each state to learn from the experience of others. Moreover, as the Supreme Court has pointed out repeatedly, federalism is also about fracturing power to preserve freedom.

Our Founders and generations of Americans have concluded that human freedom and the other benefits of federalism are worth the occasional inconvenience arising from lack of uniformity. This should be particularly true today, when technology has reduced both the benefits of uniformity and the costs of diversity.

“The Drug Quality and Security Act,” however, appears to have been the product of one of those classic deals among politicians and lobbyists. The two Senators assure us that all the “stakeholders” (i.e., groups with lobbyists) were consulted.

But were you?

http://tenthamendmentcenter.com/2013/12/30/bennett-burr-bipartisanship-yet-another-federal-power-grab/#.UsF8e1ko4eF

Easing a burden, keeping patients safe

Pharmacies in Colorado fill 60 million prescriptions every single year. In North Carolina, they fill 90 million a year. The families who take these drugs in Colorado and North Carolina, and the tens of millions more across the country, expect their medicine to be safe. For years, we haven't been able to ensure the safety of the supply chain through which prescription drugs have traveled.

We've made tremendous advances in medicine and innovation that have led to lifesaving drugs, yet we have failed to adapt to a global, complex and growing pharmaceutical drug supply chain.

In the last decade, this lack of oversight has allowed certain actors to manipulate market dynamics for their advantage, which has created uncertainty in the pricing and availability of various medications. As a result, hospitals are bombarded with calls offering them drugs on the FDA's drug shortage list that are unavailable through their contracted wholesaler. On average, they are offered these drugs at prices 650 percent higher than their contracted prices and there is no verifiable way to determine if these pharmaceuticals are even safe.

Furthermore, the FDA's repeated warnings of counterfeit drugs making their way into our prescription drug supply chain are the early warning signs of a potential and growing threat that could significantly compromise or endanger the health and well-being of patients across our country.

Establishing a strong, uniform prescription drug tracing standard will not only help prevent criminals from taking advantage of the states with the lowest supply chain security requirements, but will also save unnecessary, burdensome compliance costs that can impede economic growth.

It is for these reasons that for the past two and a half years, we have worked with drug manufacturers, wholesalers, distributors, pharmacies, patients and consumers to determine how we can create a system that will restore confidence in the safety and security of our supply chain. After countless hours of meetings and negotiations, Congress passed the Drug Quality and Security Act that was signed into law and takes effect in January. Our bipartisan bill is the first to update and establish new safeguards within the pharmaceutical drug distribution supply chain in a quarter century.

Over the next decade, manufacturers, repackagers, wholesale distributors, and pharmacies will work together to establish an interoperable electronic, unit-level system that will provide greater accountability for those along the supply chain who handle the medicine we take and which we give our children. Establishing these uniform standards will allow stakeholders greater regulatory certainty and give doctors and patients the confidence they deserve. We'll be able to more quickly address many drug shortages and recalls. Everyone along the supply chain will know that these drugs have been properly handled and kept safe for patients.

This bill is a model of what can be accomplished through hard work and pragmatism in Congress. The bipartisan effort earned the support of business groups, consumer groups, and many others. Most importantly, it will provide the tools to appropriately respond in the event of a crisis that can affect patients across the country and hopefully save lives in the process.

Sen. Michael Bennet is a Democrat from Colorado. Sen. Richard Burr is a Republican from North Carolina.


Read more: Easing a burden, keeping patients safe - The Denver Post http://www.denverpost.com/opinion/ci_24798288/easing-burden-keeping-patients-safe#ixzz2oxzEcANW

Critics: State Inspectors at Root of Pharmacy Errors

The deaths of 64 people injected with contaminated drugs created by New England Compounding Center last year drew wide public attention because of the scale of the tragedy and the mistakes uncovered after the fact, but the incident was by no means isolated.

In 2007, three people died after being injected with a compounded drug made in a Texas pharmacy. Inspectors discovered that drugs' were six times as potent as the labels indicated. Tougher state oversight would have prevented the deaths, critics say.

In 2005, a compounded medicine produced by a Maryland pharmacy for use in open-heart surgery caused severe infections and three deaths. Afterward, inspectors determined the drugs were contaminated.

In 2002, two died after being injected with tainted steroids produced by a South Carolina pharmacy. After the fact, South Carolina inspectors found the pharmacy unsanitary and its sterilization practices falling abysmally short.

A year before the NECC deaths, nine people died when they received contaminated intravenous solutions from an Alabama pharmacy. The contaminating bacteria were typically found in water and sometimes bathrooms. Investigators after the fact found the same kind of bacteria at the pharmacy, including at a faucet that dispensed tap water.

In 2012, Franck's Compounding Lab in Ocala made sterile compounds it shipped to doctors in seven states for use during eye surgeries. The drugs were contaminated with mold. Thirty-three people lost some of their sight or needed additional surgeries to try and fix what the infections destroyed.

The common theme among these episodes was that, while investigations of the deadly mishaps revealed unsanitary or unsterile conditions, each compounding pharmacy had passed inspection by its state pharmacy board prior to the mishaps.

Florida Pharmacy Board inspectors had visited Franck's before the incident, for example, and given it passing marks. After the incident, federal inspectors found extensive sterility problems at the business. The Florida Department of Health, which oversees the pharmacy board, refused to release information about the issue to the Star-Banner, claiming it would violate privacy rules. It was Franck's second serious violation in three years.

State health officials would not say why their inspectors missed violations that federal inspectors later found.

And that, critics say, is the root of so many of the mistakes made by compounding pharmacies nationwide: State pharmacy regulators in Florida and elsewhere have long lacked the expertise, training and tools to do proper inspections of compounders who produce drugs from scratch and in large quantities.

Paul Doering, professor emeritus at the University of Florida School of Pharmacy and one of the leading pharmacy experts in the state, claims flatly that Florida and other states are simply not up to the task of ensuring the safety of compounded medications.

"NECC was the wake-up call ... and now the (Florida) Board of Pharmacy is being asked to do something at a level it's never been asked to do before," he said. "The states haven't done a very good job, don't have the technical know-how, the resources, and frankly, I don't think they have the motivation to do it."

LITTLE SCRUTINY

A study by the U.S. House of Representatives this year reported that no state pharmacy board required its pharmacies to disclose how many sterile compounded drugs they made nor how much they shipped to other states; 37 states didn't even require pharmacies to report whether they made sterile compounds.

The study found that almost half of state pharmacy boards did not even maintain inspection record well enough to identify which pharmacies had repeated violations.

After the NECC debacle some states, including Florida, began taking a look at what their drug-making pharmacies were doing. The picture wasn't pretty.

Nearly one in every five Florida pharmacy making sterile compounds had serious violations.
It was the first time pharmacy board inspectors even created a separate databank for pharmacies making riskier sterile products. Before that, inspectors treated neighborhood pharmacies and compounders the same.

The Florida Pharmacy board's inspection form was a single, one-side sheet of paper. Until 2012, inspectors used the same inspection forms for non-compounding pharmacies as they did for pharmacies making complex, sterile compounds.

But it wasn't just the paperwork. Pharmacy owners say the inspections themselves were cursory.
Sam Pratt, owner of Altamonte Springs Pharmacy Specialists, said before NECC, inspectors did little more than show up "and ask how are you doing today and then leave. Before (NECC) an inspection was a joke."

Pratt also said inspections rarely took more than two hours.

Another problem is that Florida has never performed random sampling of sterile compounded drugs. Two studies by the U.S. Food and Drug Administration suggest Florida compounded drugs may not be as safe as people think.About a third of the compounded drug samples taken from various pharmacies across the country and studied by the FDA failed potency tests.

Michele Weizer, a Florida Pharmacy Board member, acknowledged that some of the oversight problems were the state's fault.

"Another part of our failure was we didn't enforce our rules," she said.

A Florida pharmacy inspector said so much of the information inspectors gather depends upon the honesty of the pharmacies.

"If they wanted to get it by me, I might not catch it," said inspector John Taylor.

And even if inspectors did enforce the rules strictly, Weizer said during a Pharmacy Board meeting this summer, they couldn't assure that the compounds created by pharmacies outside Florida were safe when they were shipped here.

A FRAGMENTED APPROACH

Howard Sklamberg, director of FDA's office of compliance, said that pharmacy problems leading up to the NECC debacle were not surprising. They were bound to happen as pharmacies made more complex sterile compounds vulnerable to contamination, made them in bulk and shipped them across state lines.

Sklamberg says a significant problem is that the compounding industry is overseen by 50 state pharmacy boards, each with different compounding rules and no coordination or universal oversight.
Those pharmacy boards were never designed to regulate businesses making the kinds of complex sterile drugs they do now.

Nor were pharmacy boards ever meant to regulate pharmacies that make large volumes of sterile compounds, sometimes in the thousands of doses, he said.

"States do not have the expertise and resources to inspect" (sterile compounding pharmacies)," he said.

Congress reached a similar conclusion in a study this year. The study revealed that 37 of the nation's 50 pharmacy boards failed to inspect all of their pharmacies during the previous 12 months. Some failed to even track the number of their inspections and many failed to keep track of out-of-state pharmacies doing business in their states.

And, like Florida, most did not know until recently which pharmacies even compounded drugs, much less made complex, risky sterile compounds.

Ken Baker, an Arizona pharmacy lawyer and former executive at Pharmacists Mutual Companies, a company that insures pharmacies, said the sheer volume of drugs being compounded without strict oversight poses a problem.

There is no shortage of pharmacies making sterile drugs.

Among the 8,000 pharmacies in Florida, 946 reported producing sterile drugs. About a third of those are out-of-state pharmacies that are also licensed here in Florida but follow their own state production rules.

Of Florida's pharmacies, 314 reported that they produce sterile compounds in bulk and 95 say they make sterile drugs in bulk to sell to doctor's offices and other health care facilities.

What is driving the surge in compounding pharmacies is money.

Pratt, the owner of Altamonte Springs Pharmacy Specialists, said doctors contribute to the problem by pushing for lower prices and are willing to go to compounding pharmacists offering the lowest prices without regard for the safety of the items being produced.

Chris Schulte is the owner of Apothecary Chris compounding pharmacy in Pensacola. He is a member of the board of International Academy of Compounding Pharmacists.

Schulte said he had the same problem making sterile drugs at prices that could compete with other pharmacies that cut corners or did shoddy work.

"I lost several accounts in this area" when NECC offered the steroid "at roughly half the price." Schulte said.

Schulte said it was common for doctors' offices to ask for compounded, sterile drugs only to complain about the price and then buy it from pharmacies at cut-rate prices. Between 20 percent and 25 percent of Apothecary's prescriptions are for sterile compounds but those prescriptions account for only about 2 percent of its revenue.

The pharmacy is accredited by the Pharmacy Compounding Accreditation Board. The organization also created the U.S. Pharmacopeia Standards for sterile compounded products referred to as USP 797.

Only about 2 percent of pharmacies are accredited by the board, and Schulte said they are at a competitive disadvantage against pharmacies which cut corners for profits. In addition, pharmacies following accreditation procedures have seen their costs to make safer drugs rise considerably, he said.

"It's hard to compete against non-accredited labs," he said.

Brian Kahan, a Boca Raton lawyer representing about 100 pharmacies, defends compounding as a necessary service.

The need for customized, compounded medicines grew because patients wanted and needed them, he said.

Kahan thinks that one of the reasons companies like NECC grew wasn't because regulators allowed them to produce drugs unchecked but because they filled a niche when FDA-regulated manufacturers stopped making unprofitable drugs.

Pratt and Isler disagree. They said that about the time NECC was making its contaminated steroid batches, the steroid was readily available through FDA manufacturers.

Dr. Allan Vrable, who owns 13 pain clinics in North Florida, said he never ordered drugs from NECC and found all he needed for his pain clinics through commercial manufacturers.
Chris Schulte thinks that the problems that led to NECC and the 64 deaths isn't such an isolated incident. Much of the process and regulatory infrastructure that saw it happen is still in place.
Asked about the potential for a disaster like NECC in Florida, Schulte said only, "I wish I could say no," and shrugged.

http://www.theledger.com/article/20131227/NEWS/131229329/0/PHOTOS52?template=printart

Drug shortage update

ORLANDO, Fla. (Ivanhoe Newswire) -- There has been increasingly frequent drug shortages in the U.S. during the past decade—and the problem has hit almost every drug class.

In a recent report from the International Society for Pharmaceutical Engineering, quality problems—like contamination—account for 46 percent of all drug shortages.


Only 54 percent of the members surveyed said they did have a drug shortage prevention program and only half of those said that prevented a shortage.

So, what is being done to help manage the problem?

Last year, Duke Medical Center adopted an approach based on models used in organ donations. For example, key drugs for cancer are distributed to patients with the greatest need and to those who could benefit most.

To help avoid shortages, Vanderbilt has increased their budget by half-a-million dollars to build up their drug supply on hand.

A South Texas Hospital System has opened its own multi-million dollar distribution center that allows it to buy drugs in bulk.

Healthcare professionals say that as of now, the shortages that are the most concerning include electrolytes, like potassium phosphate, and oncology medications. For a complete list of drug shortages, go to: http://www.fda.gov/drugs/drugsafety/drugshortages/ucm050792.htm.

There do seem to be fewer shortages because in 2012, there were 117 compared to 251 in 2011, but the focus now is on the types of medicines.

In late October, the FDA announced a new proposal to try and head off more shortages of crucial medications. Under the proposed rule, companies that make medically important prescription medicines would have to notify the FDA six months ahead of any changes that could disrupt the U.S. supply, including plans to discontinue a product or manufacturing changes that could slow production.

http://www.mysuncoast.com/health/news/drug-shortage-update/article_2d2848b6-68d6-11e3-967a-0019bb30f31a.html

Shortage in flu medication worries pharmacists

LITTLE ROCK, Ark. (KTHV) - "We can't find the regular adult dose anywhere right now," Dr. Ray Turnage explained.

Turnage is one of many pharmacists dealing with a shortage of Tamiflu. He said, "There's only one manufacturer for that drug and nationwide all the wholesalers are saying it's a manufacture delay."
Tamiflu is the only medication on the market used to treat the flu and with a shortage in the drug, it could create problems for patients needing it. "Probably the demand is exceeding their supply. So that's the problem is we can't even get adult doses right now," Turnage continued.

Although there have been very minimal cases of the flu this year in Little Rock, with 3 to 4 months left in the flu season, that could change pretty quickly. If it does, Tamiflu in stock could disappear. Turnage said, "That's part of the situation is a few families can, if they can find it, can take all that the pharmacy may have."

http://www.thv11.com/news/article/292401/2/Shortage-in-flu-medication-worry-pharmacists

Hospira Issues Recall

Hospira Issues a Voluntary Nationwide Recall of One Lot of Lidocaine HCl Injection, USP, 2%, 5 Ml in 5 Ml Vial, Due to Presence of Particulate Matter

http://www.fda.gov/Safety/Recalls/ucm379739.htm

Settlement reached over deadly U.S. meningitis outbreak

Owners and insurers of a now-bankrupt Massachusetts pharmacy linked to a deadly meningitis outbreak have agreed to pay more than $100 million to compensate victims, families of victims and creditors.

The preliminary settlement announced on Monday, which requires court approval, would resolve many claims arising from tainted steroid injections linked to New England Compounding Pharmacy Inc of Framingham, Massachusetts.

According to the Centers for Disease Control and Prevention, at least 64 people died and 751 were sickened in 20 U.S. states by injections of methylprednisolone acetate, a drug typically used to ease back pain.

The outbreak occurred after NECC shipped tainted vials of the steroid to medical facilities throughout the United States.

NECC filed for bankruptcy protection Dec. 21, 2012, two months after shutting down as the outbreak began.

Thomas Sobol, a partner at Hagens Berman Sobol Shapiro representing a plaintiffs' steering committee, called the accord "a big step forward in getting justice for victims."

Kristen Johnson Parker, another Hagens Berman partner, in a phone interview said, "All victims of the NECC tragedy should be able to share in the funds."

NECC's owners, bankruptcy trustee Paul Moore and lawyers for a committee of unsecured NECC creditors also confirmed the settlement in a joint statement. The owners denied liability or wrongdoing.

Settlement funds are expected to come from the owners, insurers, tax refunds and proceeds from the sale of a related business.

"We are pleased that a significant amount of funds will become available for distribution to victims and their families as compensation for the deaths, injuries and suffering they endured as a result of this tragic meningitis outbreak," said Moore, a partner at Duane Morris.

The accord requires final documentation and does not cover claims against various clinics that sold the tainted steroid or various vendors used by NECC.

According to NECC's bankruptcy filing, the company's equity shareholders were Carla Conigliaro with a 55 percent stake, Barry Cadden and Lisa Conigliaro Cadden each with a 17.5 percent stake, and Gregory Conigliaro with a 10 percent stake.

A lawyer for the owners did not immediately respond to a request for comment.

The case is In re: New England Compounding Pharmacy Inc, U.S. Bankruptcy Court, District of Massachusetts, No. 12-19882. (Reporting by Jonathan Stempel in New York; Editing by Bill Trott)

http://www.reuters.com/article/2013/12/24/necc-meningitis-settlement-idUSL2N0K21IM20131224

$100 million agreement close in tainted drug case

The owners and insurers of the bankrupt Framingham pharmacy blamed for an outbreak of fungal meningitis that killed dozens of people last year have tentatively agreed to contribute more than $100 million to compensate victims and creditors of the firm.

The proposed settlement, which needs to be finalized and approved by the US Bankruptcy Court, provides hope that people across the country who received tainted steroid injections made by New England Compounding Center could begin receiving initial payments for their pain and medical expenses as early as next year.

“We are working very hard to expedite this process and get money to victims as quickly as possible,” said Paul D. Moore, the bankruptcy trustee who took the lead in negotiating the deal. “This is a first step, although a significant one.”

The US Centers for Disease Control and Prevention estimate that at least 751 people contracted meningitis or other infections from the pain shots, including 64 who died in 20 states, making it one of the largest cases of tainted drugs in US history. Overall, as many as 14,000 patients received the tainted injections, and, beyond those diagnosed with meningitis, some reported suffering fatigue or other symptoms.

It is still not clear how much victims and their families would each receive from the deal, since people have until Jan. 15 to file claims with the US Bankruptcy Court. But it will probably amount to at least tens of thousands of dollars, or more, on average.

Roughly one-quarter of the settlement is expected to come from insurance companies, with the rest coming in cash and assets from five members of the Massachusetts families that founded and operated New England Compounding and its sister companies: Barry and Lisa Cadden and Douglas, Carla, and Greg Conigliaro, according to three lawyers who asked not to be named because the details of the settlement have not yet been announced.

The $100 million also includes tax refunds the owners are expected to receive because of business losses resulting from the closing of the companies, as well as the estimated proceeds from selling Ameridose, a Westborough drug maker with ties to the Framingham drug company.

Ameridose, which suspended its operations last year, is already in the process of being sold.

The pharmacy’s spokesman and lawyers representing the owners of New England Compounding and insurers could not be reached late Monday for comment on the deal.

One of the lead lawyers representing victims said the $100 million figure is a compromise but will avoid lengthy and costly litigation.

“This proposal makes it possible for victims to potentially receive funds in 2014,” said Thomas Sobol, managing partner of Hagens Berman’s Boston office. “It’s a realistic amount that could be achieved now.”

The settlement comes as the deadline fast approaches for victims to file claims.

Even if the court approves the settlement, as is expected, a judge must still decide how to divide the money among victims and creditors, as well as how much will go toward fees for the bankruptcy trustee and other professionals involved in the case.

That means checks to victims won’t go out right away.

And there could be multiple rounds of payments. In addition to the initial $100 million, plaintiffs lawyers hope to win tens of millions more by pursuing additional claims against anyone else who could potentially be liable — from hospitals that administered the injections to the companies that designed and maintained the company’s clean room, the dust-free space at the pharmacy where lab workers made sterile drugs.

Federal inspectors found dirty mats, black specks floating in vials, and other signs the room was contaminated.

A few of those parties have already agreed to mediation, but the process could take years to be resolved in court, lawyers cautioned. And victims’ lawyers said they doubt they can ever recover enough money to fully compensate victims, given the extent of deaths and injuries, and the fact that New England Compounding had scant assets.

“By no means is anyone going to say this is enough,” said William R. Baldiga, a partner at the Boston law firm Brown Rudnick who is representing the committee of unsecured creditors owed money by the company. “It’s a matter of personal tragedy.”

The situation is not unprecedented. Within a year after a 2011 listeria outbreak that killed 33 people was traced to tainted cantaloupes from Jensen Farms, lawyers collected only $4 million from the bankrupt company’s estate and insurers. But lawyers are still pursuing claims against other companies that could be liable, such as grocery stores that sold the fruit, in hopes of securing additional compensation.

New England Compounding’s owners and employees still face potential criminal charges in the case.

Carmen Ortiz, the US attorney for Massachusetts, said last month that a yearlong federal investigation in the case was “moving forward” but could not say when indictments might be issued.

Michigan, where many of the victims lived, has said it might pursue criminal charges if it finds state laws were broken.

The episode inspired federal legislation, which President Obama signed into law last month, aimed at increasing federal oversight of compounding pharmacies to avoid similar cases.

Critics say compounding pharmacies, which custom-make medications for individuals who need speciality drugs not available elsewhere, have not traditionally received enough scrutiny because they are mainly overseen by states, rather than the US Food and Drug Administration, even when companies ship large volumes of drugs across state lines like bigger manufacturers. But some watchdogs and industry observers disagree about whether the law will have much impact.

http://www.bostonglobe.com/metro/2013/12/23/meningitis/E97yWKhnC2LyIHRek4KjKJ/story.html?rss_id=Top-GNP

Massachusetts Pharmacy in Settlement Over Tainted Injections

The Massachusetts pharmacy whose tainted steroid injections were blamed for a deadly outbreak of fungal meningitis has agreed to pay more than $100 million to victims and their families, according to lawyers involved in a tentative settlement.

The tentative deal is part of an effort to compensate victims and their families for injuries they suffered after receiving the injections for back pain. The plaintiffs are seeking additional money from the dozens of medical clinics that administered the tainted injections, said Thomas Sobol, lead lawyer for the victims.

"This is the first step in the process that we hope will generate more funds from others involved," said Paul Moore, the court-appointed bankruptcy trustee for the pharmacy, New England Compounding Center, of Framingham, Mass. The center suspended operations last year.

Of the 14,000 who received the tainted injections last year, 64 died and about 700 others fell ill, according to the Centers for Disease Control and Prevention. The outbreak raised concerns about the regulation of compounding pharmacies, which custom-mix large batches of medications generally not available from pharmaceutical companies.

The tentative settlement, announced Monday, would create a fund of more than $100 million to pay for the pain and suffering and wrongful deaths of victims, according to lawyers involved in the litigation. Hundreds of victims have sued New England Compounding in state and federal courts. The pharmacy also has a small number of other creditors, like suppliers and utilities.

Victims or their families could begin receiving checks sometime next year, Mr. Sobol said. First, lawyers must work out how much they will take in fees and expenses. "Although this pot is a good amount, it's still going to fall far short of compensating victims, so we're hoping lawyers will be frugal in what they ask for," said Mr. Sobol, a lawyer at Hagens Berman Sobol Shapiro LLP in Boston.

A federal bankruptcy court in Boston must also sign off on the agreement, which it could do as early as January, said Mr. Moore, of Duane Morris LLP in Boston.

Treatment of the infections is still perplexing doctors and health authorities. Late last month, President Barack Obama signed a bill aiming to strengthen oversight of compounding pharmacies, either by the U.S. Food and Drug Administration or by state pharmacy boards.

http://online.wsj.com/news/articles/SB10001424052702304244904579276820914851760

Drug shortage list climbs to 300+. What are hospitals, politicians, manufacturers doing about it?

The prescription drug Dopamine is so valuable to Dayton Children's Hospital that what is left of its dwindling supply is kept in a vault, accessible only by the medical center's pharmacists.
The drug isn't the only one proving difficult to keep in stock; it is one of hundreds in short supply nationwide.

"When you start hearing about life-saving medications not being available, that gets really scary," said Nancy Severt, pharmacy operations manager at Dayton Children's.

Drug shortages have been commonplace for years, but the problem has grown more serious at hospitals and Emergency Medical Service agencies. According to the U.S. Food and Drug Administration, 56 drug shortages were reported in 2006; by 2011, the number had climbed to 251. The FDA's list includes drugs that have "the greatest impact on public health."


Reasons for increased shortages include fewer manufacturers as some exit the market; quality-control issues and scrutiny by the FDA, which can shut down production; product recalls; increased demand; and a lack of raw materials.

The vast majority of drugs deemed to be in short supply are produced by generic drug companies. For example, 64 entries were logged on the American Society of Health-System Pharmacists web site the week of Dec. 9. Thirty of the hard-to-get drugs were made by drug giant Hospira, a suburban Chicago company that recently pledged to invest $1 billion in its operation.

The ASHP site currently has more than 300 entries listed under "current shortages." Updated daily, the list includes recognizable names such as heparin, DTaP vaccine, dextrose and caffeine. It also includes exotics such as the black widow anti-venom.

"Do we have a shortage of stuff that matters? Yes, we do. There's some stuff (on the list) that scares the hell out of me," said Ernest Boyd, executive director of the Ohio Pharmacists Association.
Dan Gueth, director of pharmacy at Miami Valley Hospital, said he grapples with drug shortages virtually every day.

"It's been a nightmare over the last two years," said Gueth, who has been on the job since 1985. "I might have 10 products on my list, but it's likely I'm going to be told about another back order and we have to scramble."

Scramble mode
Hospitals have buyers who search for additional supplies from drug manufacturers, wholesalers and other medical centers when shortages persist.

But sometimes, as with the dwindling supply of Dopamine at Dayton Children's, extreme measures are put in place.

"We have vials of it and make up drips specifically for that patient," Servert said of the drug which sustains blood pressure in critically ill patients. "We're down to probably five vials of Dopomine. We were able to get the adult version of premix bags, so just to make sure it doesn't get intermixed with anything else I've got it locked up in a vault that only the pharmacists can access."

The hospital also worries about electrolytes and other injectables used to make formula to feed babies. It also faces decisions on what patients get certain pain medications when they are not in abundant supply.

Sometimes, care-givers have to pivot when a drug is discontinued. That was the case in the spring when the supply of the popular sedative chloral hydrate ran out after two drug companies stopped making it in the past five years.

"The doctors liked the way it acted, they liked the way it didn't linger for hours and hours," Severt said. "The drug companies were making it, but the demand wasn't very high so they decided, 'We're not selling enough to make any money.' Our institution was very reliant on it.

"We had to start ordering it as a raw powder, so our doctors had to find alternatives. Now ... we do our own testing, compounding and make sure we have a viable shelf life for it."

Propofol, the anesthetic made famous in the investigation of the death of pop icon Michael Jackson, currently is produced by a single company. It is a drug Severt says is in "critical shortage" nationwide and at Dayton Children's, which has to administer the drug in smaller doses required for kids.
"We might use 5-to-10 milliliters out of a 20-milliliter vial. So we'd have a vial that we'd barely use and we'd have to remind our anesthesiologists to throw it out. We can't reuse it.

"(The shortage) has been going on so long it seems like common practice now."

At Miami Valley, Gueth can rattle off a handful of drugs whose availability concern him, despite his pharmacy's buying power as part of Premier Health. For hospitals, shortages can mean extra cost.
"We have a national contract with our GPO (group purchasing organization) to keep our costs low, but when a product becomes unavailable I might have to pay a higher cost," he said.

Dayton Children's is part of a network of more than 30 hospitals that work together to monitor shortages and make timely purchases.

"As soon as I know it's short in Dallas, I start shopping for that product," said Kevin Myers, the hospital's pharmacy purchasing manager.

Experts say the so-called "gray market" is one of the factors that is driving up prices. Manufacturers generally sell their products to wholesalers, which then sell to hospitals. But secondary wholesalers also buy drugs and charge higher prices 0n the drugs they buy.

"The gray market, in which companies are charging up to 1,704 percent more for a product than what a facility would have to pay, definitely needs to be monitored and price-gouging eliminated," said Donna Smith of Arizona-based Avella Specialty Pharmacy.

A bill designed to clamp down on the gray market is pending before a House subcommittee.
First-responders

Hospitals aren't the only ones being squeezed by drug shortages. First-responders have fought shortages for years.

Pain-killers such as Morphine and Fentanyl are staples in ambulances and medical helicopters. But there's no guarantee the drugs will always be available.

"If you've got the biggest bone in your body, the femur, broken in a car crash, and we're taking you down the road and there are a couple of potholes, you want something for pain -- you deserve something for pain," said David Gerstner, president of the Greater Miami Valley Emergency Medical Services Council. "There have been times where we might not have it."

Gerstner said 23 hospitals supply drugs to 118 member agencies in the region through the Drug Bag Exchange Program. After first-responders administer a drug, they take their bags to a hospital for refills.

But sometimes they can't get there fast enough.

"We had some drug bags with no drug to treat seizures," Gerstner said. "So the saying became that the only drug we could use to treat seizures was diesel fuel. Put them in the back of the medic and run like hell to the hospital."

Dr. Carol Cunningham has served for nearly 10 years as state medical director for the Ohio Department of Public Safety Division -- EMS. She constantly worries about running out of injectables used to care for cardiac resuscitation, pain control and the management of seizures.

"It happens every week, there is something short," she said.

Closing down
Manufacturers leaving the business reduces the supply of some drugs. The Ben Venue Laboratory in suburban Cleveland ceased production and is shutting down due to quality-control issues. Its closing will not only cost the small town of Bedford more than 1,000 jobs, it will mean one fewer big player in the drug business.

One of the drugs previously made at Ben Venue was Doxil, a popular cancer-fighting injectable. Ben Venue was the only plant in the U.S. that made the drug, but an ongoing shortage was softened when a company in India gained FDA approval earlier this year to produce a brand-name substitute and a generic version of the drug.

"For a while, (Doxil) was restricted by the manufacturer," Miami Valley's Gueth said. "The company would only ship it if you had a patient that had already been started on the product. Oncologists in the area that may have wanted to start a patient on Doxil but couldn't had to use alternative chemotherapy agents."

Quality-control issues are the most prevalent reason for drug shortages. According to the FDA, manufacturing issues and delays or capacity issues accounted for 77 percent of sterile injectable shortages in 2012. Increased demand triggered 7 percent of shortages, as did discontinuation of products.

"The economic downturn in 2008 precipitated the issue. Manufacturers cut back on spending and some drugs that didn't make money were discontinued, and as a result the production shortages became exaggerated," said Robert Weber, Administrator for Pharmacy Services at the Ohio State

University Wexner Medical Center and Assistant Dean in the College of Pharmacy.

Generics and savings
Generic drugs save consumers big money -- $1.3 trillion in the past decade according to the Generic Pharmaceutical Association. But they also undercut brand-name drugs, which can lead to shortages if the brand-name drug companies cut production.

Drug patents expire after 20 years, but exclusive marketing rights can expire much sooner, leaving a small window for brand-name products to reap big profits to fund research and development.

Exclusivity, according to the FDA, was "designed to promote a balance between new drug innovation and generic drug competition."

"Generic companies -- Bedford, American Regent -- jump in and start making a product when it comes off patent," Dayton Children's Myers said. "That reduces the price, and all the sudden they have problems manufacturing it. It just disappears."

Generic companies also undercut each other, which leads to lower profit margins. Still, some think they should see past the bottom line.

"I believe that manufacturers have a moral and ethical responsibility to continue making lifesaving drugs or drugs that can medically alleviate a severe disease, and to make them affordable for patients and payers when possible," Smith said. "However, many times the shortage is out of their control, and any negative economic impacts cannot be dismissed."

Generic drug-makers contacted for this story would not make executives available to answer questions. A Hospira spokesman said the company is "investing hundreds of millions of dollars to help prevent future shortages," and is working to increase capacity at existing facilities, build additional capacity (Hospira is adding a plant in India), and strengthen its supply chain.

More production would be good news for Myers, who used to see a couple drug reps every day. Now he sees that many in a week.

"I had a Bedford sales rep that came in every week and she's gone. American Regent, she's gone. They have nothing to sell," he said. "They're keeping a low profile because they don't like to get pounded. When they come in here, we're all over them because we need the product."

Expiration dates
One solution that could ease the drug shortage problem is more lenient expiration dates. The dates are set by the drug companies, but some health districts around the country have extended them on some products. That could only happen in Ohio if all medical agencies agreed.

Proponents of such a policy say there is no harm in using drugs that are nearly full strength.

"I've always felt the expiration dates are for the benefit of the companies," Boyd said. "Does sugar become cheese after three years? If it's packaged properly, it's not going to deteriorate. I wouldn't do it with insulin or anything that has to be refrigerated, but the majority of the stuff we put in tablets is not."

There is a program already in place that allows for the use of expired drugs. The U.S. Department of Defense's Shelf Life Extension Program, launched in 1986, extends the dates on some drugs in the federal stockpile. Those drugs must be tested periodically by the FDA, a cost most public agencies could not stomach.

The Ohio Department of Health distributed a survey this fall to all EMS agencies asking for a list of drugs critical for medical care, with an eye on pushing for more flexible expiration dates.

"The frustrating thing for us as physicians is the manufacturers determine the expiration date, not the FDA," Cunningham said.

"Even if they're 95 percent effective, if that's the only thing out there and if you have one of those conditions -- you're in cardiac arrest or you're having a seizure or real pain -- do you really care if it's 95 percent, as long as it's not contaminated?"

Effective drugs taken off shelves when they hit their expiration dateraise medical center costs.
"You can't flush them down the toilet or throw them in the trash, so we're paying to get rid of something we'd like to keep that's still good and useful, and in some places we don't have a replacement for it," Gerstner said. "This makes sense how?"
FDA policy
The FDA wants d
rug companies to give earlier notice when production lags. The Food and Drug Administration Safety and Innovation Act, signed into law in July 2012, requires manufacturers to report drug stoppages or delays at least six months in advance of the action.

The agency is taking comments until Jan. 4 on a rule that would expand the list of drugs that fall under that reporting law.

The FDA does not have the power to order companies to make drugs, but it says it works with firms that manufacture similar drugs, asking them to increase production to prevent or reduce the impact of shortages.

Meanwhile, hospitals and first-responders search for alternatives if their first choice is not an option, at times putting patients in harm's way.

"I've heard in the past few years of surgeries being postponed or cancelled because of certain meds not being available," Boyd said. "I wouldn't be scared to ask your hospital in advance if they have the meds you need."

Drugs that stop bleeding, check cancer and sedate patients are not the only products pharmacists worry about. Basic formulas are in short supply, too.

"Sodium bicarbonate was a huge one," Dayton Children's Severt said. "That's baking soda. We just can't get it in a sterile injectable form because the company decided to stop making it."

-- Drugs in short supply
The American Society of Health-System Pharmacists lists more than 300 drugs on its drug shortage bulletin. Here are some of the drugs on the list, with their uses and comments from Miami Valley Hospital Director of Pharmacy Dan Gueth:

Atropine: Used to stabilize heart rate after heart attack or during surgery.
Status: Currently an anticipated shortage through 2015; getting allocations, repackage multi-dose vials into single-dose syringes to preserve supply at times.

Caffeine & Ergotamine Tartrate: Caffeine injectable formulation for headache.
Status: Has been unavailable for two years; have been using alternative agents.

Epinephrine injection: Emergency treatment for severe allergic reactions.
Status: Very limited supply; constantly scrambling to find product to meet our needs; MVH has never run out.

Dextrose 50% injection: Pure form of sugar often used to help diabetics.
Status: Currently available again; previously, shortage required MVH to repackage from large-volume solutions to smaller 50-ml syringe.

Glycopyrrolate: Treats peptic ulcers, dries mouth for surgery.
Status: Currently an anticipated shortage through 1st quarter 2014; atropine being used as alternative agent although it is in short supply, also.

Heparin infusion bags: Blood thinner that prevents clots in blood vessels.
Status: MVH has switched vendors and formulation multiple times to address shortages over the past two years.

Methylergonovine: Used to stop hemorrhaging post-delivery.
Status: Getting limited supply; will utilize oxytocin if supplies exhausted.

Nicardipine: Used for hypertension and for neuro-critical care patients.
Status: Supply issues have forced us to bounce back and forth between premix bag and vials that require mixing components; requires more staff time when we mix the components.

Prochlorperazine: Used for severe headache in ER, although caffeine was original agent of choice.
Status: Unavailable for a long period of time; recently available again but very limited supply.

Propofol: Sedative for surgery and other procedures.
Status: Currently only manufactured by one company; Hospira's inability to supply (plant shutdown) creating pressure on one vendor to meet demand; currently meeting our demand with allocations.
Watch our exclusive video of how staff at Miami Valley Hospital uses technology to better monitor drug supplies at mydaytondailynews.com

"It's been a nightmare over the last two years. I might have 10 products on my list, but it's likely I'm going to be told about another back order and we have to scramble."

Dan Gueth, director of pharmacy, Miami Valley Hospital

"It's been a nightmare over the last two years. I might have 10 products on my list, but it's likely I'm going to be told about another back order and we have to scramble."


Read more: http://medcitynews.com/2013/12/theres-short-supply-300-drugs-hospitals-politicians-generic-producers-handling-drug-shortages/#ixzz2oJJ48MIP

Today's Shortages

ASHP/FDA
Atorvastatin Tablets
Azithromycin Injection
Cefazolin Injection
Isosorbide Dinitrate Immediate Release Tablets
Naproxen Oral Suspension
Rocuronium Injection
Tiopronin Tablets
Vancomycin Hydrochloride Injection

Changing times don't bring changing rules for compounders

Corner drugstores or drug manufacturers? That is the central question driving the debate over pharmaceutical compounders.

Many compounders conduct business like small drug manufacturers, yet they are monitored more like neighborhood pharmacies by the state departments of health and pharmacy boards, who may not even be aware of which pharmacies are simply dispensing drugs and which are mixing new compounds.

More than half of Florida's 8,000 pharmacies now make compounded drugs. Twelve percent, or 946, make the riskier sterile compounds, according to a Florida Board of Pharmacy survey last year.

One of the reasons pharmacies can out-compete manufacturers in making compounded drugs, sterile and otherwise, is because pharmacies are not regulated by the U.S. Food and Drug Administration and aren't burdened by more stringent federal regulations, referred to as Good Manufacturing Practices. Instead, they follow more lenient rules outlined by their own states.

Paul Doering, professor emeritus at University of Florida School of Pharmacy, said he believes if they had to follow the FDA's Good Manufacturing Practices, “it would signal the end of pharmacies doing sterile compounding.

“That would put them on the same (playing field) as the major pharmaceuticals. They wouldn't be able to do it on a shoestring anymore,” Doering said.

Pharmacists like John Taylor agree.

Taylor had worked at Franck's Compounding Lab in Ocala before the lab mixed a bad batch of vitamin supplement that killed 21 prized polo ponies several years ago. He returned afterward to help improve the business' compounding practices.

“I'm embarrassed personally and professionally” to have worked at Franck's, said Taylor, who headed Franck's customer service department.

Franck's later compounded a bad mixture of medications to be used in eye surgeries. A number of people were injured by the contaminated solution, authorities say.

Taylor had quit before the pharmacy's problems with the eyewash, saying “there was no commitment (by Franck's) to rehabilitation.”

Taylor said by the time he left the pharmacy it was filling hundreds of prescriptions per day. Working there also made him lose his faith in pharmacies' abilities to make compounds safely, especially those filling many prescriptions or sending them out the door in bulk.

He said he also doesn't think state compounding rules are sufficient to ensure that risky medicines are made safely.

One expert who helped update the rules most pharmacies, including those in Florida, follow in making high-risk compounds, says that those compounding laws were never meant for large-scale facilities that make sterile drugs in bulk.

The U.S. Pharmacopeial Convention is a scientific nonprofit body that sets standards for the quality and strength of medicines worldwide. Eric Kastango was appointed to the USP's panel for sterile compounding from 2005-10 and re-elected in 2010, but resigned to form his own company. Kastango helped create the latest version of USP Chapter 797, which is the criteria most state pharmacy boards use in determining how pharmacies make sterile compounds.

The Florida rule for sterile compounding, which incorporates much of USP 797, is 64B16 -27.797.

The Florida Board of Pharmacy contends its sterile compounding rules are sufficient to ensure a safe, sterile product, whether the pharmacy is making single prescriptions or bulk batches sent to hospitals or doctors for office use.

“No, that is absolutely erroneous,” Kastango said.

He said the USP 797 was intended for single-prescription, sterile compounding.

“797's standards no longer match the volumes being produced,” he said. “It's a quantity issue. That is where these pharmacies fail. Their behaviors become more and more risky.

“797 is the minimum ... and very few of the pharmacies are training their people (technicians) correctly. The FDA holds their manufacturers accountable,” he said.

Meanwhile, Kastango said states that allow office-use compounding, including Florida, are “state havens” for pharmacies that want to mass produce risky drugs but want to do it under the guise of a pharmacy and by way of office-use compounding.

“They are manufacturing in Florida,” he said. “If you can't tie your prescription to a patient (when making sterile compounds), then it's no longer a pharmacy, it's a manufacturer, and USP 797 is not adequate.”

Forty-two states allow office-use compounding.

Stephen Byrn, a professor at the Purdue University Department of Industrial and Physical Pharmacy, said USP 797, and other state rules that incorporate it, fall short in protecting the public.

Byrn also worked for the FDA, chairing its advisory committee dealing with drug manufacturing and helped write the FDA's standards for pharmaceutical makers: the Good Manufacturing Practices. He also chaired committees for USP.

Byrn said USP 797 is appropriate for pharmacies making “very limited” quantities — 10 or so doses — of a drug. It's also a good set of guidelines for hospital pharmacies making a drug that is not otherwise available and immediately needed for a patient, he said.

“But if a pharmacy makes 1,000 doses and ships them, it's not safe,” Byrn said.

Byrn and Kastango say there are fundamental differences between the FDA's GMP and USP 797 standards.

Manufacturers and compounding pharmacies purchase drug ingredients from around the world. These ingredients from foreign suppliers do not necessarily have the same production controls that exist in the United States.

To address this problem, Byrn said, manufacturers have long-established relationships with their suppliers, often visiting producers or even permanently stationing company representatives at the plants. In addition, large pharmaceutical makers have extensive testing programs that ensure ingredients shipped to their facilities are what they say they are. That is something individual pharmacies cannot do.

Another concern with pharmacies making risky compounds is the qualifications of the people working at the facilities, Byrn said. Manufactures and their employees often specialize in the medicines they make, while compounding pharmacy employees may make a number of different substances over time. In addition, pharmaceutical companies also have specialized facilities to make specific drugs, something compounding pharmacies lack.

The FDA in 2001 and 2006 randomly tested pharmacy compounded drugs. The study was informal, the FDA admits, but was meant to glimpse the differences between drugs made by compounders and by FDA-regulated manufacturers.

Of the pharmacy-made samples obtained by the FDA in the first test, a third either lacked the prescribed amount of active ingredient on the label or had far too much.

The 2006 test, involving only sterile compounds, showed similar results. A third of the samples had potency problems, ranging from 68 percent of potency to nearly 300 percent.

In contrast, less than 2 percent of FDA-regulated manufactured drugs had potency problems, the tests showed.

“There's no question FDA is much better (regulating drug production),” Byrn said.

Manufacturers following GMP also routinely sterilize their ingredients during the process of making drugs.

Florida requires filtration of the final product and testing for contamination only of the finished drug, Byrn said. In addition, the rule only requires sterility testing of the final product if 20 or more units are produced. But inspectors do not check to ensure that is occurring.

Byrn and other critics warn that in many cases sample testing of the final product isn't sufficient because that can miss contaminated compounds.

Critics cite both the New England Compounding Center and Franck's as examples of how state standards failed.

The Star-Banner obtained the two inspection reports completed by the Florida Department of Health Pharmacy Board before the March 2012 recall of Franck's Brilliant Blue G, a dye used by surgeons to highlight internal features of the eye during surgery. The recall included products containing the corticosteroid triamcinolone acetonide, which is injected into the eye to treat certain conditions.

Both inspections were conducted in September 2011 and neither showed significant infractions.

After the eye drug recalls, the FDA inspected Franck's and found an array of problems.

FDA inspectors found fungal and other microbial contaminations in samples of the eye medicine. The fungus was the same strain that contaminated victims' eyes and caused loss of sight.

FDA inspectors also found multiple bacterial and fungal strains in one of the pharmacy's laminar flow hoods where compounds were made. The same contaminants were present in the clean room where sterile compounds were made.

FDA inspectors also observed technicians violate rules to keep compounds sterile and said the pharmacy failed to routinely conduct tests for the presence of microbes and fungus.

The state Health Department would not supply the Star-Banner with any documents related to Franck's eye contaminant incidents, citing privacy laws. It would not confirm or deny the incident occurred.

Former Franck's pharmacist John Taylor said the problems that led to the eye drug issues were not isolated.

He said that “level of contamination does not happen overnight” and is the result of an ongoing sterility problem.

In the case of the poisoned polo ponies, a Health Department investigation concluded that a technician made a mistake weighing out ingredients. The lab was fined $14,387. The Florida Board of Pharmacy planned to place Franck's on probation but negotiated a lighter settlement. Pharmacy board records do not indicate that Franck's ever paid the fine.

Owner Paul Franck would not comment for this story.

David Miller is the executive vice president of the International Academy of Compounding Pharmacists, an organization with more than 2,000 pharmacist members. He said the answer is not to abandon USP 797 but to get more state pharmacy boards to sign on.

Miller said fewer than 20 states follow USP 797.

“That's one of our major focus. To get USP 797 made a national standard for sterile compounding,” he said.

He said that the USP 797 standards were established over a long period of time and are “extremely difficult to comply with.” He argues that anyone who believes the code was designed for mom-and-pop pharmacies “never read the 400 pages of USP 797.”

He said that USP 797 is “as rigorous ... as FDA has for manufacturers doing large batches.”

For those that contend that the federal GMP will solve all of the compounding ills, Miller cites the FDA's failure to act in the NECC case before contaminated drugs were sent to patients.

He said that the FDA had worked with the Massachusetts Board of Pharmacy and knew of NECC's problems.

But Howard Sklamberg, director of the FDA office of compliance, said the discussion of USP 797 and GMP should not be confused with the FDA's involvement with the NECC case.

Sklamberg said federal laws left it unclear who was in charge of overseeing NECC. In September, U.S. Senate and House committees agreed on a bill that would clarify the FDA's authority to investigate pharmacies apparently not complying with their state rules.

Sklamberg said another problem is the variety of rules that are being used to regulate pharmacies. Each state imposes its own set of rules and there's little across-the-board consistency.

The problem is amplified in that most states allow out-of-state pharmacies to ship sterile drugs across state lines and to health facilities. Florida requires only that the out-of-state pharmacy has complied with their pharmacy boards. It does not require out-of-state pharmacies to comply with Florida pharmacy rules.

He said the issue is not a competition whether the FDA or states should oversee large-scale compounding, but rather only the FDA can bring to the table a high standard applicable to all states.

“GMP was designed with large-scale production in mind, USP 797 wasn't,” Sklamberg said.

http://www.ocala.com/article/20131222/ARTICLES/131229949/1001/NEWS01?template=printart

Abrams Royal compounding pharmacy recalls all sterile products after adverse event, FDA reports: Food and Drug recalls

CLEVELAND, Ohio-- Abrams Royal Compounding Pharmacy, a Dallas-based pharmaceutical product supplier, is recalling all of its unexpired sterile products after an adverse event related to their use, according to a Food and Drug Administration news release.

The products include injectable medications, IVs, eye drops, pellet implants, nasal sprays, inhalation solutions and eye ointments, and were shipped nationwide to health care facilities, physicians and patients from June 17 to Dec. 17.
The company is recalling the products because a patient in California who received a compounded medication from the pharmacy had an adverse event, according to the FDA. In August, the FDA recalled all sterile products from another Dallas compounding pharmacy, ApothéCure, Inc., after 15 people in two Texas hospitals became ill with bacterial bloodstream infections.

http://www.cleveland.com/healthfit/index.ssf/2013/12/abrams_royal_compounding_pharm.html