Wednesday, April 17, 2013

House Committee Levels Sharp Criticism At FDA Over Meningitis Outbreak.

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Yesterday, Food and Drug Administration Commissioner Dr. Margaret Hamburg appeared at a hearing before the House Energy and Commerce Subcommittee on Oversight and Investigations in which both Democrats and Republicans leveled sharp criticism upon the FDA for its role in failing to prevent what became a deadly meningitis outbreak caused by tainted steroid products from the New England Compounding Center. Major print media and Washington insider sources carrying the story underscore the harsh nature of the criticisms leveled at the FDA, particularly from Republicans. After admitting that her agency could have acted in a more aggressive fashion and conceding the need for better policing of compounding pharmacies, Hamburg took the opportunity to ask for Federal legislation requiring all compounding pharmacies to register with the FDA.

        The Washington Post (4/17, Kindy) reports, "After reviewing 27,000 pages of documents from the Food and Drug Administration, Republicans and Democrats came to different conclusions about the agency's ability to prevent one of the worst public health crises in American history." Yesterday, "Republican members of the House Energy and Commerce Committee said...that its six-month investigation into the FDA's role in last fall's meningitis outbreak shows the agency knew for a decade about serious safety lapses at the specialized pharmacy that made the tainted drugs but failed to act." In addition, Dr. Hamburg, the "only person scheduled to testify at the hearing, was sharply criticized about the agency's efforts with the" New England Compounding Center (NECC).

        The New York Times (4/17, A15, Tavernise, Subscription Publication) reports that on Tuesday, Dr. Hamburg "told Congress...that her agency should have acted more aggressively against compounding pharmacies like the one that was responsible for a deadly meningitis outbreak last fall. In a hearing before a House Energy and Commerce subcommittee, she said the agency had become overly concerned about avoiding lawsuits, and as a result did not police the industry as effectively as it could have." Hamburg stated, "I think we allowed ourselves to be far too cautious because of fears of litigation that might further undermine our authority."

        The Los Angeles Times (4/17, Morin) "Science Now" blog reports that Commissioner Hamburg "endured heavy criticism Tuesday as House members accused the agency of failing to act on complaints against the New England Compounding Center, the Massachusetts firm linked to an outbreak of deadly meningitis. Under harsh questioning from Republican and Democratic lawmakers, FDA Commissioner Margaret Hamburg conceded that her agency could have handled the situation better." Hamburg told the committee, "I wish we had been more aggressive, and I can assure you that we are being more aggressive now."

        The AP (4/17) reports, "Republicans and Democrats took turns chastising the FDA for not being aggressive enough in going after compounding pharmacies like the New England Compounding Center, the specialty pharmacy which produced tainted pain injections that have sickened more than 700 people and killed 53 others. In the second hearing on the outbreak, FDA Commissioner Margaret Hamburg reiterated that her agency needs clearer authority to go after compounding pharmacies, which have challenged the FDA's authority in court since the 1990s." According to Hamburg, the FDA "is working to crack down on compounding pharmacies, despite legal challenges."

        Bloomberg News (4/17, Edney) points out, "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." However, "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."

        The Tennessean (4/16, Barton) reports that Hamburg "described the evolution of large-scale compounders like NECC, with production far exceeding that of neighborhood pharmacists who compound, or mix drugs, in response to prescriptions that apply to just one patient. 'It is clear that the industry and the health-care system have evolved and have outgrown the law, and FDA's ability to take action against (large-scale compounding) has been hampered by gaps and ambiguities in the law, which have led to legal challenges to FDA's authority to inspect pharmacies and take appropriate enforcement actions,' Hamburg testified."

        Modern Healthcare (4/17, Block, Subscription Publication) reports that at yesterday's hearing, Hamburg "warned lawmakers...that if Congress doesn't clarify and strengthen the FDA's authority over certain types of compounders, another NECC-type situation could happen." In particular, "Hamburg asked for legislation that requires all compounders to register with the agency. In addition, she called for uniform quality standards to abide by and mandatory reporting of adverse events to the FDA. Currently, section 503(a) of the Food, Drugs and Cosmetics Act exempts compounders from certain regulations that apply to other drug manufacturers."

        The Hill (4/17, Viebeck) "Healthwatch" blog quotes Hamburg as saying, "The tools we have for regulating these firms are simply not the right fit." She called "for new powers to regulate firms like the NECC, which fall between compounder and drug manufacturers. States traditionally oversee the former category, while federal authorities oversees the latter."

        CQ (4/17, Ethridge, Subscription Publication) reports that "Democrats on the subcommittee agreed that confusion prevented the agency from acting effectively to respond to complaints and concerns with the company. Several backed Hamburg's request for Congress to act to clarify the agency's authority, as well as give it new regulatory powers over compounding pharmacies." But, "Republicans said they were not sure that the agency was ready to implement any new authorities, and several accused the agency of using the conflicting court decisions as an excuse for not taking more aggressive action."

        Also covering the story are Politico (4/17, Norman), Reuters (4/17, Clarke), the NBC News (4/17, James) "Vitals" blog, and MedPage Today (4/17, Pittman).

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