The answer to FDA’s legal problems with regulating compounding may come through a designation of responsibility rather than a formal expansion of authority.

Commissioner Margaret Hamburg labored through hours of criticism from House and Senate committees during two days of hearings to defend FDA actions related to the problems at the New England Compounding Center that led to a deadly outbreak of meningitis.

Leaders in the House and Senate appear committed to moving legislation, although it likely will not be in the coming weeks.

Hamburg said there was confusion about whether FDA or Massachusetts authorities primarily were responsible for regulating Framingham, Mass.-based NECC and other compounders, and asked for more authority for the agency. But many legislators feel FDA already has the ability to inspect and shut down large-scale compounders like NECC that are not following its rules.

Small-scale, traditional compounding for individual patients is not at issue – what is demanding attention is non-traditional compounders like NECC that are operating more like manufacturers.

Legislation still seems likely, but may end up focusing on drawing the line of responsibility between state and federal agencies to clear up the confusion, rather than simply giving FDA more power over the practice.

Sen. Lamar Alexander, R-Tenn., wants someone “on the flag pole” – meaning one agency, either state or federal, is responsible for ensuring the riskier non-traditional compounders meet the set standards.

Alexander proposed allowing FDA to designate state boards of pharmacy as the primary regulator, if they are willing and able. If the state regulators proved unable or made mistakes, FDA would have the ability to take over regulation.

“I’d like to be able to come back … six months from now after we’ve worked together to pass a law and hear representatives of state boards of pharmacy say this is my responsibility and this is what we’re doing about it and hear the FDA say this is our responsibility,” Alexander said during a Nov. 15 Health, Education, Labor and Pensions Committee hearing on the outbreak. “I don’t want to hear this joint responsibility, that they were supposed to do it, and we could have done it, and nobody did it.”

Hamburg seemed to like the idea, saying it was one model that could be explored, but still wanted federal regulations to assure consistency.

“I think it should be made explicit,” she said. “I think for non-traditional compounding there should be federal standards that apply to certain types of practices that go to issues of quality and safety.”

FDA’s proposal for increased regulation of compounding would place non-traditional compounders under FDA’s purview. States would handle the traditional practice, which would be defined as preparing medications for individual patients with a prescription.

Non-traditional compounding includes operations where there is a medical need, but also a higher risk because the drug is being made without a prescription or at a high volume.

FDA said those facilities should be required to submit to inspections, report adverse events and register with the agency.

Compounding complex dosage forms and copies of approved drugs, except under special circumstances, also would be prohibited.

The proposal for increased authority did not go over well when Hamburg presented it Nov. 14 to the House Energy and Commerce Oversight and Investigations Subcommittee. Several members said a warning letter issued to NECC in 2006 indicated the agency felt it could regulate the facility.

Hamburg testified that one of the reasons more authority was needed was to clear up the legal gray area ([A#14121114007]).

A Line In The Sand: Dispenser Or Manufacturer

Once responsibilities are clarified, legislators also would have to determine which facilities are subject to increased regulation.

The line may be drawn between compounders considered to be manufacturing in a legal sense and those that are solely dispensing drugs, although opinions varied about how to make the distinction.

HELP Committee Chairman Tom Harkin, D-Iowa, suggested any compounding facility shipping across state lines should come under FDA scrutiny. Other ideas included using a volume threshold and prescription records.

David Miller, executive VP and CEO of the International Academy of Compounding Pharmacy, said size and volume should not be considered part of the equation. He said traditional compounders are those that dispense a drug to fill a prescription. Manufacturers would be compounders that make a drug before receiving a prescription.

That is in part why Miller said he thought FDA already had the authority to inspect and shut down NECC. IACP said in written testimony NECC should have been forced to register as a manufacturer and comply with Good Manufacturing Practices.

Miller also said FDA’s tiered system may be too complicated.

“I fill prescriptions,” said Miller, who is a registered pharmacist. “The difference between NECC and a compounding pharmacy is they weren’t filling prescriptions. They were bulk manufacturing and selling.”

A Question Of Resources

If FDA is going to gain more responsibility in the compounding area, budgeting likely will become a significant issue.

Harkin and other committee members said FDA cannot continue receiving additional responsibilities without the proper funding.

Alexander said after the hearing that if FDA had to regulate only those compounding pharmacies that behave like manufacturers in states that chose not to take the responsibility, the agency may not need more resources.

“I don’t think it’s a question of money, it’s who’s on the flag pole,” Alexander said.

Hamburg did not appear as optimistic during the hearing. When Alexander asked if she wanted total responsibility to regulate some compounding pharmacies, such as the non-traditional facilities, Hamburg said it may be the best outcome.

But she also said it remains unclear exactly how many of those facilities there are in the country because they do not have to register with FDA.

Hamburg indicated a large number could stretch resources significantly, but seemed to imply a user fee system could be an option to pay for it.

“It would be a real challenge,” she said. “Of course our other inspectional activities over drug manufacturers, we have user fees to support our budget…”

FDA already is dealing with several new mandates that are expected along with new revenue from user fee programs enacted this year. Fees for generic drugs are expected to create more staff to review applications and inspect manufacturing facilities, but the agency also is expected to speed up both processes Also see "GDUFA Guidance Offers Peek At Generic Drug User Fee Levels" - Pink Sheet, 27 August, 2012..

Sequestration, if allowed to take effect, almost certainly would dampen any attempt to regulate compounding. The agency would lose an estimated $319 million from its budget, which would slow existing operations significantly ([A#14120914006]).

A Long Legislative Road Ahead

Leaders in the House and Senate appear committed to moving legislation, although it likely will not be in the coming weeks.

Rep. Henry Waxman, D-Calif., the Energy and Commerce Committee ranking member, said Congress should pass compounding reforms during the lame-duck session because if it is delayed until next year, lobbyists could stop it.

Alexander did not think the lobbying groups would have any luck killing a compounding bill, given the legislative motivation created by the outbreak.

HELP Committee hopes to move legislation next year, but research into possible changes will take some time.

A slower approach to reform appears much more likely. Harkin said the HELP Committee hopes to move legislation next year, but research into possible changes will take some time.

Harkin said the committee is sending letters to each state’s board of pharmacy to learn more about their compounding regulations and inform its work. Those comments likely will take several months to solicit and review.

House legislation already is pending. Rep. Ed Markey, D-Mass., introduced a bill Nov. 2 that would create more FDA authority over compounding, including many of the items the agency wants. Rep. Rosa DeLauro, D-Conn., also expects to introduce a bill to strengthen federal authority over the practice.

The Markey bill may become the foundation to build policy with the support of most stakeholders. Drug shortage legislation took a similar path to its inclusion in FDA user fee legislation Also see "Compounding Hearings Are First Step In Creating Active Legislative Ingredients" - Pink Sheet, 13 November, 2012..

Compounding The Problem: Congress, FDA Argue Over Regulatory Responsibility

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