House Democrats, GOP Disagree on FDA Authority Over Pharmacies

Posted November 14, 2012 at 3:27pm

Although both parties have urged a bipartisan response to the recent fungal meningitis outbreak, House Democrats pushed for legislation Wednesday that clarifies the Food and Drug Administration’s authority over compounding pharmacies, while Republicans expressed skepticism that a gap currently exists.

At a House Energy and Commerce Oversight Subcommittee hearing, Henry A. Waxman, the top Democrat on the full panel, said Congress should move “to correct the law” on a bipartisan basis before lawmakers head home at the end of the year. The often-heated hearing focused on whether the outbreak, which has been linked to a contaminated injectable steroid produced by a Massachusetts compounding pharmacy, could have been prevented.

“We’re going to be held responsible as members of Congress to make sure the law is clear and that the agency has the ability and resources to do the job that everybody expects you should have done,” Waxman, D.-Calif., told FDA Commissioner Margaret A. Hamburg. “And we want to make sure that you’re able to do it.”

Hamburg said her agency has “ambiguous, fragmented, unclear and contested authorities” over compounding pharmacies, noting that they are exempt from key parts of FDA law and that a “disconnect” exists between legal requirements across the country.

“I think there’s an enormous lack of clarity, and I think we should seize this opportunity to address it,” she said.

Hamburg said her agency would like to see a “risk-based framework” in which traditional compounding, or creating a customized medication for a particular patient, would be overseen at the state level. But she said there is a need for new legislation to provide FDA with broader authority over so-called non-traditional compounding, which “involve larger volume, more complex products, including sterile products, and broader distribution, potentially putting more patients at risk.”

The outbreak has been linked to 461 cases of illness across 19 states so far, including 32 deaths, according to the Centers for Disease Control and Prevention.

But Republicans said they believe FDA already had the necessary authority and repeatedly pressed Hamburg to state whether the agency had the power to shut down the New England Compounding Center.

“If there really is a lack of regulatory authority at some level, then that’s a legitimate policy recommendation,” said Texas Republican Joe L. Barton. “But if there’s not a lack of regulatory authority in existence in state and federal law right now, then it’s unnecessary.”

Full committee Chairman Fred Upton, R-Mich., also criticized the agency for not turning over documents related to the company that his panel has requested. He asked for a commitment that Hamburg would be fully responsive to questions from both parties so the committee can figure out what went wrong and patients can be assured of their safety going forward.

“This is not going to be the last hearing, because we don’t have the information that we need to proceed,” Upton said.

Speaking to reporters after the hearing, Subcommittee Chairman Cliff Stearns of Florida said Republicans are receptive to passing legislation on the issue this session. But he agreed that Congress still lacks the information it needs to legislate and maintained that GOP lawmakers cannot find any reason the FDA did not act after it issued a warning letter in 2006.

“If the FDA would provide this information, we would be glad to consider legislation,” he said.

Edward J. Markey, D-Mass., has introduced a bill (HR 6584) that would increase FDA regulation of compounding pharmacies, and Rosa DeLauro, D-Conn., also plans to introduce a measure soon.

While Republicans — and, at times, even Democrats — openly expressed frustration with Hamburg’s winding responses during questioning, lawmakers praised the interim commissioner of the Massachusetts Department of Public Health for acknowledging the board of pharmacy’s role in the events. Lauren Smith, who took her position less than three weeks ago, said Massachusetts had re-examined its regulations for compounding pharmacies and enacted a series of emergency regulations on Nov. 1.

The hearing also featured emotional testimony from Joyce Lovelace, whose husband died in September as a result of receiving contaminated steroid injections.

But Barry J. Cadden, president, co-owner and director of pharmacy for the New England Compounding Center, invoked his Fifth Amendment rights and refused to answer lawmakers’ questions. When Cadden confirmed that he would continue to invoke those rights in response to every inquiry, Stearns excused him, adding that the committee would recall him if necessary.

Upton had issued a subpoena for Cadden to testify last week after he declined to appear before the panel.

The Senate Health, Education, Labor and Pensions Committee will hold its own hearing on the outbreak Thursday, and Cadden has been invited to testify.