FDA seeks more authority amid meningitis outbreak

Associated Press Modified: November 14, 2012 at 8:32 pm •  Published: November 14, 2012
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WASHINGTON (AP) — The head of the Food and Drug Administration asked Congress Wednesday for more authority to police pharmacies like the one that triggered a deadly meningitis outbreak, even as lawmakers questioned why the agency didn't do more with its existing powers.

FDA Commissioner Margaret Hamburg called for new laws to clarify her agency's authority to crack down on companies like the New England Compounding Center, which distributed contaminated pain injections that have sickened more than 460 Americans and caused 32 deaths.

Members of the House Energy and Commerce Committee spent most of the first hearing on the outbreak questioning state and federal regulators about why they didn't act sooner against the company.

A timeline assembled by the committee's Republican staff showed that the FDA and the Massachusetts board of pharmacy investigated the pharmacy more than a dozen times in the past decade. In particular, lawmakers pointed to a 2002 FDA inspection that found contamination issues with the same steroid implicated in the latest recall.

"I was stunned and angered to learn that an inspection of the NECC by the FDA and the Massachusetts board of pharmacy over 10 years ago identified contamination in the very same drug at issue in the current outbreak," said Rep. Fred Upton, R-Mich., who chairs the committee.

Hamburg told lawmakers that the problems uncovered in inspections were "very serious," but that the agency was obligated to defer to Massachusetts authorities, who have more direct oversight over pharmacies.

Hamburg emphasized repeatedly the difficulty of taking action against compounding pharmacies, which have long operated in a legal gray area between state and federal law.

"The challenge we have today is that there is a patchwork of legal authorities that oversee the regulatory actions we can take," said Hamburg, who was nominated to head the FDA by President Obama in 2009.

Compounding pharmacies traditionally fill special orders placed by doctors for individual patients, turning out a small number of customized formulas each week. They are typically overseen by state pharmacy boards.

In the last two decades some compounders, like the NECC, have grown into large businesses that ship thousands of doses of drugs to multiple states. Hamburg said that when her agency tries to intervene in those cases they face a "crazy quilt," of court rulings, which are split on whether the federal government has authority over pharmacies.

Republicans pressed Hamburg to answer simple "yes or no" questions about the agency's stance, to which she countered with lengthy, nuanced explanations. Lawmakers repeatedly accused the commissioner of evading their questions.

"You're the grand poobah of the FDA and I'm asking you, 'could you have prevented this tragedy?' and you're saying you couldn't have because you don't have jurisdiction," said Rep. Cliff Stearns, R-Fla., in one particularly heated exchange.

"No, I'm saying it's very hard to know if any one action we might have taken would have stopped this terrible tragedy," Hamburg said.

Even some Democrats, who normally side with Obama administration officials at such hearings, seemed to lose their patience.