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.