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FDA chief vows to get 'aggressive' with compounding pharmacies

April 16, 2013|By Monte Morin
  • Food and Drug Administration Commissioner Margaret Hamburg, shown in a previous Capitol Hill appearance, faced harsh questioning from lawmakers on Tuesday.
Food and Drug Administration Commissioner Margaret Hamburg, shown in… (Susan Walsh / Associated…)

The head of the U.S. Food and Drug Agency 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.

"I wish we had been more aggressive, and I can assure you that we are being more aggressive now," Hamburg told members of the House Energy and Commerce Subcommittee on Oversight and Investigations.

The fungal meningitis outbreak last summer resulted in the deaths of 51 people, and more than 730 more were sickened. Authorities say the illnesses were brought on by tainted steroids distributed by the New England Compounding Center.

In comments before the committee, Hamburg said the deaths -- as well as 18 more related to other compounding incidents over the last two decades -- were the result of a rapidly growing industry and conflicting laws that limited FDA oversight and authority.

But Rep. Tim Murphy (R-Pa.), the subcommittee chairman, and other members said the FDA had enough power to act on concerns about the compounding pharmacy. They cited a recent flurry of enforcement actions in which FDA personnel served inspection reports to 31 compounding pharmacies.

Those violations included black particles floating in medication, rust and mold in "clean rooms," where injectable drugs are packaged, and workers handling sterile products with bare hands.

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