Lawmakers Question FDA's Role in Meningitis Outbreak

9:09 AM, Nov 16, 2012   |    comments
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By TOM WILEMON and PAUL C. BARTON -- Gannett Washington, DC

WASHINGTON -- In the wake of back-to-back hearings on the fungal meningitis outbreak before committees of the U.S. Senate and House of Representatives, several ideas are floating about Capitol Hill on how to prevent another tragedy like the one that has sickened 461 Americans, killing 32 of them.

Sen. Lamar Alexander, R-Tenn., laid the blame squarely at the feet of the Massachusetts Board of Pharmacy, saying it should be shut down and proposing a framework that would allow federal regulators to take over when state agencies fail to adequately monitor compounding labs.

U.S. Rep. Ed Markey, D-Mass., has introduced legislation that would give the U.S. Food and Drug Administration clearer authority to police the labs. The New England Compounding Center, located in his district, is accused of shipping contaminated drugs that led to the outbreak.

But other lawmakers say the FDA simply failed to use its existing authority.

"We have an antiquated system to try to fit a square peg into a round hole," said FDA Commissioner Dr. Margaret "Peggy" Hamburg, noting that it was established before hospitals and surgery clinics began outsourcing their compounding needs.

Hamburg said her agency needs legislation mandating clear authority to access records of compounding labs with large-scale operations, mandatory reporting of patient harm by the labs, additional registration requirements to coordinate whether appropriate oversight should be at the state or federal level, and clearer safety guidance on medicine labels for health care clinicians.

But Alexander is leery of any tiered responsibility. He believes the "flagpole" theory might work best.

"My experience as governor was that whenever I gave a job to more than one person, sometimes it came back not done," he said, saying someone has to be "on the flagpole" and accountable for results.

If a state can't do the job of monitoring compounding labs, he said, federal officials should take over the duties.

"The Massachusetts Board of Pharmacy had the clear authority to deal with this problem," Alexander said. "They just were incompetent in dealing with it. If anybody is going to be shut down, they should be shut down."

Opposition dropped

In a significant political development during the hearing, David Miller, representing the International Academy of Compounding Pharmacists, signaled his group would no longer oppose legislation to clarify FDA authority over large-scale compounding. The group had lobbied against a 2007 bill that would have made that clarification.

Alexander said he sees bipartisan legislation to make that change being introduced at the start of the 113th Congress in January. It's a bill that should have fairly clear sailing, he said afterward.

Miller questioned the judgment of health care facilities that ordered medicines from NECC.

But Dr. Marion Kainer, who led the Tennessee Department of Health's response to the outbreak, said health care clinicians often do not understand the differences between a compounding lab and an FDA-monitored drug manufacturer.

The Tennessee Medical Association, which was invited to submit a report to the committee, asked Congress to take action.

"Prior to this outbreak, the prevailing perception among the physician community in Tennessee was that compounding pharmacies were as regulated as manufacturing pharmacies," said the comment letter. "We now know differently."

State wins praise

During the hearing, Tennessee was lauded as a bright spot in the public health system.

If Tennessee had delayed acting for as little as nine additional days, the state would have suffered at least five more deaths and more than 50 additional cases, Kainer testified.

The crisis is far from over, she added. "In Tennessee, we still have many patients hospitalized and suffering from complications and others who are exposed and frightened that they may become infected."

But that didn't stop Sen. Barbara Mikulski from praising her. "Tennessee was really doing their public health job," the Maryland Democrat said.

'Unclear' structure

Hamburg, whom President Barack Obama appointed commissioner in 2009, continued to argue that her agency is hindered by a "limited, unclear and contested" regulatory structure when it comes to large-scale compounders.

For the most part, senators weren't buying her arguments, saying the agency had powers it didn't use.

If the FDA gets additional authority, Sen. Richard Blumenthal, D-Conn., said, "Will the FDA use this authority more vigorously than it has used its authority to date?"

He added, "I think the conclusion is inescapable that this tragedy could have and should have been prevented."

Sen. Pat Roberts, R-Kan., noted inspections and other unfavorable reports about NECC the FDA knew about, including its own warning letter sent to the company in 2006.

"This has been going on since 2002. It's amazing," Roberts said. "It took all this time and nobody did anything."

Between state and federal officials now, Alexander told reporters afterward, "My biggest frustration is that nobody's at fault."

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