Congress to FDA – Cough Up NECC Docs, Or Else

Congress to FDA – Cough Up NECC Docs, Or Else

February 4th, 2013 // 6:45 pm @

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Nearly four months after the House Energy and Commerce Committee asked the FDA to provide all documentation concerning its oversight of the New England Compounding Center, which was linked to the fungal meningitis outbreak, the agency has yet to deliver the goods. So late last week, the committee threatened to issue a subpoena if the documents are not turned over by February 25.

The meningitis outbreak, which has been linked to 693 cases, including as many as 45 deaths (see here), became one of the biggest public health crises in the US in decades, and prompted bitter complaints that both Massachusetts health authorities and the FDA did not sufficiently exercise their regulatory powers.

At a hearing last November, the FDA was criticized for failing to pursue enforcement action against the NECC, even though the agency issued a 2006 warning letter and the compounder had regularly shipped large volumes of compounded medicines around the country. The FDA has argued that court rulings have compromised its authority, although the agency had previously declared a willingness to pursue compounders that engage in the equivalent of drug manufacturing (back story).

Since then, the New England Compounding Center has filed for bankruptcy, Massachusetts has proposed new laws to upgrade supervision and enforcement (see this) and the FDA has proposed that two forms of compounding should be created so that higher-risk production can be more closely regulated.

But the committee remains frustrated that the FDA has not cooperated with its probe. The lawmakers contend that the FDA has failed to produce any internal communications from 2002 through 2006, when the agency conducted three inspections of NECC facilities, documented numerous public health and safety concerns, and considered enforcement actions. The FDA has also failed to produce any communication from staff and officials at FDA headquarters who were making decisions about NECC, the lawmakers complain.

“The few communications FDA has produced to the committee from the account of one district office employee raise new and troubling questions about the agency’s oversight of NECC after the December 2006 Warning Letter up until the recent outbreak, including why FDA failed to re-inspect the company’s facility. FDA’s repeated inaction is even more troubling in that it runs counter to remarks you gave early in your tenure during a speech entitled, ‘Effective Enforcement and Benefits to Public Health,’ ” the committee writes FDA commish Margaret Hamburg.

“In that speech, you noted the need to ‘follow-up on signals indicating problems’ and promptly ‘assess whether or not a company has made required changes in its practices.’ In order for the committee to fully understand why FDA never re-inspected NECC or took any meaningful enforcement action against the company, despite repeatedly asserting that it could and would do so, the agency must cooperate with the committee’s investigation and fully respond to our request for internal communications and memoranda” (here is the letter).

An FDA spokeswoman sent us this response: “The FDA is working diligently to respond to the request and recognizes the important role of the committee’s oversight function. We began providing the committee with documents in October 2012 and to date, the agency has produced 3,591 pages of documents related to NECC and Ameridose (another compounder connected to the NECC owners).

“These documents include correspondence from FDA’s district offices and FDA headquarters as well as inspectional documents and adverse event records from the 2002-2006 timeframe. We remain committed to working with Congress to find a legislative pathway designed to help prevent tragedies like the meningitis outbreak in the future.”


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