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Lawmakers say FDA fell short in policing pharmacy

April 16, 2013

WASHINGTON (AP) — House lawmakers said Tuesday that the Food and Drug Administration had numerous opportunities over nearly a decade to stop the Massachusetts pharmacy responsible for a deadly meningitis outbreak that has killed more than 50 Americans.

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.

Hamburg said her agency is working to crack down on compounding pharmacies, despite legal challenges.

“I wish we had been more aggressive, and I can assure you that we are being more aggressive now,” Hamburg told lawmakers.

The wave of fungal meningitis infections was first identified in September and grew into one of the deadliest medication-related outbreaks in U.S. history. The NECC halted operations in October and faces over 100 lawsuits in federal court.

But more than half a year later, lawmakers in Washington continue to debate who should be held accountable for the outbreak and whether it could have been prevented.

Republicans said Tuesday that the FDA should have shut down the NECC based on complaints from doctors, patients, hospitals and state pharmacy regulators. The FDA first inspected the NECC in 2002 and issued a warning letter in 2006 over the pharmacy’s production of copies of manufactured drugs without patient prescriptions. Between 2007 and 2012 the FDA continued to receive complaints about the company from anonymous whistleblowers and state pharmacy regulators, according to internal documents released by the committee.

“Ten years of warning signs, alarm bells, and flashing red lights were deliberately ignored,” said Rep. Tim Murphy, R-Pa., who chairs the House Energy and Commerce Subcommittee on Oversight and Investigations. Murphy and other Republicans pointed to correspondence in thousands of pages of FDA documents turned over to the committee.

Democrats agreed that the FDA should have been more aggressive, but also supported the agency’s argument that outdated laws and conflicting court decisions have hamstrung federal efforts at policing pharmacies.

“These documents show us that the FDA has been grappling with a law that is broken, and we need to help fix that law and keep the American public safe,” said Rep. Diana Degette, D-Colo., the subcommittee’s ranking member.

Compounding pharmacies mix customized medications based on doctors’ prescriptions, and have traditionally been overseen by state pharmacy boards. But in recent years, the FDA has tried to police larger compounders like the NECC, which operate more like manufacturers by mass producing drugs and shipping them across state lines.

Last week the FDA completed a wave of inspections targeting about 30 compounding pharmacies with a history of complaints or problems. Inspectors reported finding a host of potential safety hazards, including rust and mold in supposedly sterile rooms.

Republicans charged that this “flurry of well-publicized activity” only proves that FDA has the ability to shut down pharmacies like the NECC.

“No law has changed. The only change is the FDA decided to act,” Murphy said.

Republicans pressured Hamburg to explain a 2011 FDA decision to suspend routine inspections of compounding pharmacies, including the NECC. Hamburg said agency lawyers recommended the halt in enforcement due to legal questions about the agency’s authority to police compounding pharmacies. Hamburg told lawmakers she was unaware of the policy at the time.

“I regret that I was not more fully aware,” Hamburg said.

Congressional Democrats acknowledged that the FDA did not act quickly enough, but placed the blame on a complicated legal landscape.

Rep. Henry Waxman, D-Calif., and other Democrats said Congress should pass be working to clarify FDA’s authority.

An effort to draft new legislation on compounding pharmacies has made little headway in the House, which is controlled by Republicans. However, Senate lawmakers are expected to introduce a bill in coming weeks that would subject large compounding pharmacies to new requirements, similar to large drug manufacturers.

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