In Midst of Deadly Outbreak, FDA Commissioner Acknowledges Missed Opportunities to Protect Public Health Highlighted in FDA’s Internal Documents

April 16, 2013

WASHINGTON, DC – The Oversight and Investigations Subcommittee, chaired by Rep. Tim Murphy (R-PA), today held a hearing to examine the deadly meningitis outbreak, which has resulted in 53 lost lives and over 700 individuals sickened. With FDA internal documents revealing FDA had numerous opportunities to address warning signs and complaints about the New England Compounding Center and its sister company, Ameridose, members questioned FDA Commissioner Margaret Hamburg on the FDA’s failure to act sooner.

“This committee has discovered the agency had information that should have spurred it to act and stop this rogue outfit from continuing to operate as an illegal manufacturer of sterile medication,” said Chairman Murphy. “This outbreak is not ‘complex’ nor was it a surprise. Neither NECC nor its sister company, Ameridose, were operating in the shadows. They were under the nose of the FDA for a decade. FDA’s primary mission is to protect the public health from unsafe drug products.”

Oversight and Investigations Subcommittee Vice Chair Michael C. Burgess, M.D. (R-TX) challenged Hamburg’s assertion that the agency didn’t have sufficient authority and expressed concern over the FDA’s failure to act before 53 individuals died.

Congressman Morgan Griffith (R-VA) sought answers on why FDA did not follow up on mounting complaints from state pharmacists that Ameridose was acting as a manufacturer not a compounder. Griffith commented, “There was an inspection request and as a part of that inspection request attached to that was background info on what you ought to do and one of those was to look into that information, but you all never did that with Ameridose did you?”

Highlighting the litany of complaints FDA received, Rep. Steve Scalise (R-LA) questioned whether the agency forwarded the complaints to the state regulators so they could have taken action. Scalise asked, “This is a yes or no question. Did you forward any of these complaints to the state of Massachusetts prior to the deaths? Any of them?” According to internal documents provided by FDA, the agency failed to routinely, if ever, inform the state.

Given the long and frequent history of NECC complaints, Rep. Bill Johnson (R-OH) quizzed the Commissioner on the agency’s decision-making process of determining which facilities to inspect. Johnson stated, “What causes you enough alarm to want to go inspect? If event reports that say public health is in danger and that lives are in danger if that’s not enough I’d like to be able to understand that…The heart of my concern is the judgment used by the FDA to decide who to inspect and who not to inspect, and based upon your testimony here now I have even further questions about that.”

In response to Chairman Murphy’s inquiry on whether FDA has conducted an internal review to address communication gaps, Commissioner Hamburg was unable to specify policy to address the FDA’s failures. Murphy stated, “I am not satisfied with you telling me you’re going to try, you’re going to review, you’re going to discuss. I think this is what hamstrung the agency for the past ten years.”

“On numerous occasions, the agency confronted a choice in dealing with NECC and Ameridose: take action to protect patients or wait. Repeatedly, the FDA made a conscious decision to do nothing. In particular, under your watch, Dr. Hamburg, the FDA put enforcement actions against NECC and Ameridose on hold in 2011 and through 2012, because the FDA lawyers wanted to wait until finishing a revision of a guidance document,” concluded Murphy.

To read the committee's report that chronicles FDA's missed opportunities to protect the public health from the meningitis outbreak, click here.

To view photos from today’s hearing, click here.

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