U.S. regulators failed to act as aggressively as they could against compounding pharmacies like the one at the center of the deadly meningitis outbreak, Food and Drug Administration Commissioner Margaret A. Hamburg said.
A review of past practices shows that “even in the face of litigation and continuous challenges by industry to our authorities, we can nonetheless be more aggressive in pursuing enforcement actions,” Hamburg said in written testimony presented today to a House Energy and Commerce subcommittee. “I can assure you that we are being more aggressive now.”
The FDA had cited conflicting legal decisions on its authority over drug compounders to deflect criticism by lawmakers that the agency didn’t act early enough to shut down New England Compounding Pharmacy Inc., the company at the center of the meningitis outbreak that killed more than 50 people. Republican lawmakers said the FDA already has the power to act when these pharmacies stray from traditional practices of mixing personalized medicines for individual prescriptions.
“We now know that there was nothing in the law that prevented the FDA from acting,” said Representative Tim Murphy of Pennsylvania, the Republican chairman of the subcommittee.
Republicans on the subcommittee released documents yesterday that they said show the agency received a litany of complaints about New England Compounding, or NECC, and a related business called Ameridose LLC. Some of those complaints involved the safety and sterility of the companies’ products, they said.
NECC Complaints
Republicans have questioned whether the FDA could have shut down the pharmacy based on incidents dating as far back as 2002. They also want to know why the FDA didn’t re-inspect NECC after stating it would in a 2006 warning letter and related correspondence two years later.
“They were under the nose of the FDA for decades,” Murphy said at today’s hearing. “Ten years of warning signs, alarm bells, and flashing red lights were ignored.”
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