FDA is arguing for more authority over some types of compounding to prevent future problems like the deadly meningitis outbreak at the New England Compounding Center, but many House members are not convinced it is necessary.

Several Republican members of the House Energy and Commerce Committee Oversight and Investigations Committee suggested during a Nov. 14 hearing that the authority already exists and the agency could have done better at preventing the outbreak.

FDA Commissioner Margaret Hamburg said conflicting court decisions called into question the agency’s jurisdiction over compounding pharmacies and proposed a new framework that would give it the ability to require inspections, adverse event reporting and registration for large operations.

Subcommittee members said they thought a bill could be passed if necessary, but were unclear why existing law does not already allow FDA to enforce its rules at a compounder, given that the agency issued a warning letter to NECC saying as such.

“It looks like they have all the authority they needed to shut that … place down and arrest the perpetrators and they didn’t do it,” Rep. Michael Burgess, R-Texas, said after the hearing on the outbreak. “I’m at a loss to explain what else they need.”

The hearing was intended to explore whether the meningitis outbreak could have been prevented Also see "Compounding Hearings Are First Step In Creating Active Legislative Ingredients" - Pink Sheet, 13 November, 2012..

It is not expected to be the last. Full Committee Chairman Fred Upton, R-Mich., said more hearings will be scheduled when the committee receives all the information it has requested from FDA.

Hamburg also is scheduled to testify about the outbreak Nov. 15 at the Senate Health, Education, Labor and Pensions Committee.

Barry Cadden, NECC president, co-owner and director of pharmacy, was subpoenaed and appeared, but did not answer questions. He invoked his Fifth Amendment right against self-incrimination and was quickly excused.

Frustration Over Hamburg’s Answers

Hamburg gave many answers during her nearly three hours of testimony and questioning, but not always to members’ satisfaction. She appeared alongside Lauren Smith, interim commissioner of the Massachusetts Department of Public Health, but many of the questions were directed at FDA.

Hamburg repeatedly indicated the agency did not have the adequate power to regulate compounders, but when asked where the statute was unclear, she did not give a specific citation.

“We have responsibilities for oversight of manufacturers and drug facilities in this country and around the world, but our authority to provide oversight of drug manufacturers is very different than our ability to oversee compounding pharmacies, which are in fact exempted from important aspects of FDA law,” she said. “We have ambiguous, fragmented, unclear and contested authority in this particular realm.”

Burgess and other subcommittee members said the warning letter FDA sent to NECC in 2006 detailed multiple problems and threatened enforcement action and implied the agency did have the authority.

“We’re just not buying it,” Burgess told Hamburg during the hearing. “FDA in writing to this compounding pharmacy [said] failure to do so could result in enforcement action including a seizure of products or injunction against the firm and its principals. That’s pretty strong language. Now you lack the authority to do anything and yet send a letter like this?”

The letter related to behavior that went beyond traditional compounding practices, but the agency has said it was not related to the outbreak Also see "FDA’s Compounding Oversight: What Price Safety?" - Pink Sheet, 15 October, 2012..

Many Democrats agreed that FDA authority needed clarification. Subcommittee Ranking Member Diana DeGette, D-Colo., said recent court decisions created confusion and allowed compounders to challenge the agency’s ability to enforce existing regulations.

“There is a lack of clarity in the law and what that means is that evil-doers like this compounding pharmacy don’t feel like they have to listen to the FDA, they don’t feel like they have to produce the documents when they’re requested, and they sue whenever there’s anything that happens,” she said.

But several members were visibly frustrated with Hamburg, in many cases because she would not answer questions succinctly. Subcommittee Chairman Cliff Stearns, R-Fla., said after the hearing he felt she was filibustering.

At one point, DeGette admitted she needed clearer responses to determine what new authority FDA should have.

“We are just trying to get answers here because we do need to figure out how to prevent this,” DeGette told Hamburg. “We have to figure out how to give you the jurisdiction to do what you need to do. ... These inconclusive answers are not helping.”

FDA Proposes Tiered Regulatory System For Compounding

Hamburg offered a risk-based framework to allow more FDA regulation of “non-traditional” compounding, while leaving the traditional practice (defined as the preparing of medications for individual patients with a prescription) to the states.

Much of the new regulation would resemble those imposed on drug manufacturers. Non-traditional compounding would include types where there is a medical need, but also a higher risk because of factors such as the amount of product being made, whether it is shipped across state lines, and whether production is initiated before or after receiving a prescription.

FDA also wants non-traditional compounders to register facilities, report adverse events and submit to inspections.

“Such inspections are necessary to determine when a pharmacy exceeds the bounds of traditional compounding, to respond to public health threats, and to enforce federal standards,” Hamburg’s written testimony states.

The agency also wants to stop the compounding of copies of approved drugs, except under special circumstances like a shortage, and complex dosage forms, such as extended-release products and most biologics.

Rep. Ed Markey, D-Mass., has introduced legislation that would make many of the requested regulatory changes. Hamburg appeared supportive of the provisions in the bill during the hearing.

If it is determined that legislation is necessary, it could move during the lame duck session of Congress that just began. Members could choose to marry it with track-and-trace legislation, which also is moving forward ([A#14121025008]).

Given GOP uncertainty about the need for reform, it appears more likely that Markey’s bill will serve as the foundation to build a compounding bill over a longer period.

Drug shortage legislation, which was included in the FDA user fee reauthorization statute enacted earlier this year, took a similar development path Also see "GOP Drug Shortage Strategy Pushes FDA Reform, Reimbursement Over Notification" - Pink Sheet, 13 February, 2012..

FDA Wants Compounding Authority Clarified, Congress Not So Sure It’s Necessary

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