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Legislators Threaten to Subpoena FDA over Requested Documents

Posted 04 February 2013 | By Alexander Gaffney, RAC

US regulators are coming under renewed scrutiny regarding their oversight of pharmaceutical compounders, with House legislators threatening to subpoena the US Food and Drug Administration for what they allege is a failure to provide relevant documents to the Energy and Commerce Committee despite repeated requests.

Background

In 2012, a rash of drug shortages caused an increase in the number of entities looking to utilize the services of pharmaceutical compounders, which ordinarily manufacture small, personalized doses of medication for use by a single consumer.

But as that increase helped to ease drug shortages, it also exposed a darker side of the industry; one in which some compounders cut corners and compounded products in unsanitary conditions. One such compounder, the New England Compounding Pharmacy (NECC), was found by FDA and Massachusetts regulators to be plagued with rampant contamination-"thick residues of orange, brown and green" in production hoods, a bird flying around a storage facility, and "thick, filamentous material" were found in two facilities operated by the owners of NECC and its sister company, Ameridose.

That contamination would eventually be linked to at least 45 deaths and hundreds of illnesses across the US, and angry legislators hauled Hamburg before two separate testycongressional hearings in November 2012.

Congressional Concerns

At those hearings, legislators frequently pressed Commissioner Margaret Hamburg on the availability of various documents detailing FDA's regulatory history with NECC, as well as the agency's authority to regulate pharmaceutical compounders in general. Hamburg repeatedly stated that state legislation and court cases have eroded FDA's authority to clearly regulate-a contention often challenged by legislators.

In her Senate hearing, Hamburg noted that there was much she could not divulge to the committee due to ongoing litigation with NECC.

But if that explanation was sufficient at the time, legislators appear to have become increasingly frustrated by their inability to access those documents as part of their own investigation into the compounding issue.

Their concerns were outlined in a 1 February 2013 letter sent to Hamburg, and referenced her testimony before the House Committee in November. Legislators wrote that they were concerned that her testimony lacked specificity regarding the scope of the problem. For example, they said, she had been unable to define the difference between "manufacturer" and "compounder" and did not specify which sections of federal law would need to be changed to accommodate the agency's request for additional regulatory authority.

Outstanding Documentation

But both of those concerns were minor, they said, compared to their ongoing requests for documents related to FDA's oversight of compounders. "Unfortunately, FDA has failed to provide the requested documents in a timely manner."

FDA, legislators said, has released some documents, but the large majority of those were already publicly available, such as Form 483 inspection reports. Other private documents produced, they added, are "markedly incomplete."

"FDA has produced three separate inspections of NECC's facilities, documented numerous public health and safety concerns, and considered enforcement actions against the firm," they continued. "FDA has produced no communications from staff and officials at FDA headquarters, who were actually making the decisions about how to address the situation at NECC. In addition, FDA took three months to produce a one-and-a-half page timeline of its involvement with the company, a document Committee staff requested on 12 October 2012 during its first teleconference with FDA related to the outbreak [of meningitis]."

Other documentation collected by the committee showed that while FDA had found NECC's facilities to be deficient in a 2006 warning letter, FDA had failed to shut the facility at that time or subsequently despite ongoing concerns raised after that letter was sent.

"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," legislators wrote. "FDA's repeated inaction is even more troubling in that it runs counter to remarks [Hamburg] made early in [her] tenure" in which she expressed the need for regulators to investigate "signals indicating problems."

Subpoena Threat and FDA Response

Legislators threatened to subpoena the documents if they are not provided to the Energy and Commerce Committee by 5 p.m. on 25 February 2013.

In a response provided to Regulatory Focus, FDA Deputy Director For Strategy Erica Jefferson explained that, "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," Jefferson continued. "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," she added.


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