FDA Can Be More Aggressive With Pharmacies, Hamburg Says

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.”

Democrats on the committee came to the FDA’s defense, citing a law that left the agency with ambiguous authority over compounding pharmacies, as well as industry lobbying to undermine federal regulation and failures by states to oversee the businesses adequately.

Conflicting court decisions on FDA’s ability to oversee compounding pharmacies led to the lack of follow-up on complaints about NECC, panel Democrats said in a review of the 27,000 pages of documents dating from 2000 to 2012 that the FDA gave the committee.

Increased Enforcement

Compounding pharmacies traditionally prepare personalized prescriptions and are regulated by state health authorities. The meningitis outbreak revealed some companies go beyond that task to produce larger amounts of medicines, acting more like a drug manufacturer overseen by the FDA.

NECC suspended operations in October and recalled about 17,676 doses of the pain-killing steroid methylprednisolone acetate after regulators determined that tainted vials of the drug were responsible for fungal meningitis infections.

The practice of compounding drugs has evolved and outgrown the law, and the FDA should have the authority to enforce U.S. manufacturing standards similar to those drugmakers must meet, Hamburg told the subcommittee in Washington. The agency is seeking the ability to inspect those facilities and obtain samples of medications and records, she said.

Murphy said he isn’t interested yet in further legislation and wants to focus on whether the FDA did all it could with its existing authority. He asked Hamburg to find out who made decisions that kept NECC from being inspected.

This is Hamburg’s second appearance before the House subcommittee to ask for greater federal oversight since the meningitis outbreak.

Industry Lobbying

The agency has stepped up enforcement efforts in the meantime, conducting 55 inspections and issuing reports detailing shortcomings at 43, Hamburg said. During those inspections, some pharmacies attempted to delay the FDA and deny them access to their records.

Since NECC, there have been seven additional recalls of sterile compounded and repackaged drugs, Hamburg said.

New guidelines that would have cleared up confusion and unfrozen enforcement actions against pharmacies that mix their own drugs were on the verge of going public before last year’s meningitis outbreak, Democrats on the House subcommittee said in a memo released yesterday. Delays issuing the guidance stemmed from at least 2006.

The agency had finished work on draft guidance in 2010 yet didn’t receive final clearance, according to the memo.

Proactive Inspections

The FDA suspended proactive inspections in 2011 that weren’t the result of a specific complaint against a compounding pharmacy until the guidance was complete, including inspections some at the agency suggested were needed of NECC and Ameridose.

Hamburg said she wasn’t involved in the decision.

“I regret that we didn’t do more,” she said. “And I regret that I wasn’t directly engaged but I am now.”

The International Academy of Compounding Pharmacists should have been made to testify today, Democrats said last week. They said documents collected from the pharmacists group show “that for almost two decades, the organization lobbied aggressively and successfully to restrict FDA authority over compounding pharmacies.”

Democrats outlined the pharmacy group’s guidance to its members for avoiding broad FDA inspections.

They also released a report yesterday claiming states have largely failed to oversee compounding pharmacies based on a survey of state regulators. Hamburg admitted the FDA could improve its communication with states after she couldn’t tell lawmakers which, if any, complaints against NECC were shared with Massachusetts officials.

“Our current system for regulating compounded medicines is in disarray,” Representative Henry Waxman, a Democrat of California, said in a statement. “There are no clear lines governing whether it should be FDA or the states overseeing compounding pharmacies.”

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