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FDA Commissioner Margaret Hamburg
Hamburg

Lawmakers grill FDA chief about meningitis outbreak


By Jessica Zigmond
Posted: November 14, 2012 - 6:45 pm ET
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A federal investigation into the nation's deadly meningitis outbreak intensified Wednesday as lawmakers grilled the Food and Drug Administration commissioner about why the FDA didn't do more to prevent the outbreak when the agency has known of problems at the company linked to the deaths for the last decade.

Meanwhile, the lawmakers were unsuccessful in retrieving any information from Barry Cadden, the president, co-owner and director of pharmacy at the New England Compounding Center, the Framingham, Mass.-based company that distributed a contaminated injectable steroid that led to the deaths of 32 Americans as of Nov. 14. Appearing before the House Energy and Commerce Oversight and Investigations Subcommittee, Cadden invoked the Fifth Amendment of the U.S. Constitution, which states no person shall be compelled to serve as a witness against himself during a criminal investigation.

After Cadden pleaded the Fifth several times, Subcommittee Chairman Cliff Stearns (R-Fla.), dismissed him as a witness in the hours-long hearing that examined the facts and actions of state and federal regulators around the recent fungal meningitis outbreak.

Both Republicans and Democrats on the panel pressed FDA Commissioner Dr. Margaret Hamburg for more information on the agency's actions, especially after the FDA had issued a warning letter to the NECC in 2006. In his opening remarks, Stearns noted that the FDA has been slow to act, given that it took the agency four years to issue such a letter after it found problems with the company's sterility practices.

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Hamburg continued to insist that the FDA requires more clarity on the federal law regarding its authority over compounding. She testified that the Food and Drug Administration Modernization Act of 1997 made changes to the Food and Drug Cosmetic Act that have resulted in court challenges and inhibited the agency's authority over compounding practices.

“The fact that we have unclear, limited and contested authorities and ambiguities in the law and a crazy quilt of legal authority has required us to be very reactive responding to those serious public health threats,” Hamburg said in response to Rep. Diana DeGette (D-Colo.), the subcommittee's ranking member, who asked Hamburg if it would help for Congress to provide more clarity on the 1997 law. Rep. Henry Waxman (D-Calif.) urged for such legislation in the remaining weeks of this current 112th Congress.

But both Stearns and Rep. Michael Burgess (R-Texas), a physician, said after the hearing that more information is needed from the FDA to know if additional legislation is appropriate. Stearns said the panel has received some 1,000 e-mails from state regulators in Massachusetts, but is still waiting for materials from the FDA.

“If we just rush to legislate something—which I know because there is a crisis, people want to do that—we're going to be back here with the same problem,” Burgess said. “If they didn't exercise the authority they already had, new authority is not going to solve this problem.”

Lawmakers on both sides complimented the work of Dr. Lauren Smith, the interim commissioner of the Massachusetts public health department, for recent changes she has made to prevent similar outbreaks in the future.

Those changes include enacting emergency regulations that will require compounding agencies to produce information regarding volume and distribution. “The volume issue is so important because if you're making numerous batches, thousands of vials of material, then effectively you're acting more like a manufacturer than the more traditional compounder,” Smith told DeGette.

Smith's department is also requiring all licensed pharmacies to report to the state if they are the subject of an investigation by other states or the federal government, and has convened a special commission that she said will identify "the best practices in strengthening oversight of this evolving industry."


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