Tuesday, February 11, 2014

Official: FDA Needs More Than Outsourcer Fees To Fund Compounding Law

An FDA official said the agency needs funding in addition to outsourcing facility fees to carry out the new drug compounding authorities provided by the recently enacted Drug Quality and Security Act, especially since enforcement will not be solely focused on facilities registered under the new law. Sally Howard, FDA's deputy commissioner for policy, planning and legislation, told FDA funding advocates Tuesday (Feb. 4) that the agency is concerned the law does not provide adequate funding for the agency to enforce its new authorities.

Howard said there are many more facilities than those that step up to federal oversight that FDA will need to inspect to ensure the safety of compounded drugs. The user fees collected from registered facilities will offset some of those inspections, but they will not be nearly enough, she said.

"In compounding there were user fees but the fees are $15,000 per registered facility....right now we have 14 facilities that are registered," she said during an Alliance for a Stronger FDA meeting Tuesday (Feb.4). "And if we could just call it a day by doing enforcement there, that would be perfectly fine, but as everyone knows that would not be appropriate."

Outsourcing facilities that register with FDA will be subject to federal quality and reporting requirements. Pharmacies that fall under exemptions for traditional drug compounding will remain under the watch of states, but state and federal regulators must communicate under the new law.

FDA has issued a slew of drug compounding policies under DQSA, established a new advisory committee, and issued the first warning letters under the law last month to two companies lacking patient-specific prescriptions (see FDA Week, Jan. 31). But Howard noted there is still more the agency must do, such as developing current Good Manufacturing Practices for outsourcing facilities.

FDA recently urged states and hospitals to rely on outsourcers that register with FDA, a move that was viewed favorably by drug safety advocates as FDA will need help from state regulators in policing the drug compounding industry.

FDA has been aggressively pressing Congress to provide more funding for laws like DQSA and the Food Safety Modernization Act that require the agency to craft industry standards and exercise new authorities. At a House hearing Wednesday (Feb. 5), Mike Taylor, FDA's deputy commissioner for foods and veterinary medicine, also told lawmakers the agency may be unable to implement a new food import system without food facility registration and import user fees (see related story).

Howard urged the FDA funding advocates to also press Congress to provide FDA with additional funding to carry out the authorities provided by DQSA.

Budget committees typically begin meeting in February and March to hash out budget resolutions. Disagreements over total funding levels have hobbled that process over the past few years. However, Steven Grossman, deputy executive director of the Alliance for a Stronger FDA, said that if the appropriations process follows the regular order this year and is driven by appropriators, rather than congressional leadership, budget subcommittees would have more time to consider "the best allocation of funds to meet national priorities, such as FDA." A normal appropriations process could also potentially provide better opportunities for the Alliance to advocate on the agency's behalf, he said. – Stephanie Beasley ( sbeasley@iwpnews.com This e-mail address is being protected from spambots. You need JavaScript enabled to view it )

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