FDA commissioner: Unfunded provisions giving agency headache

FDA Commissioner Andrew von Eschenbach told food and drug lawyers Wednesday the agency is struggling with ambiguities and a lack of resources as it works to implement an agency overhaul Congress passed in the summer.

Von Eschenbach praised much of the bill for the new authorities and drug-industry user fees it granted the agency but bemoaned other unfunded provisions that are causing FDA to reshuffle its deck. Specifically, the commissioner said a provision that requires FDA to respond to petitions regarding generic drug approval at a much speedier pace will pose problems.

"In order to meet that deadline, this will require effort, or additional effort, but the legislation did not come with additional resources for that additional effort, so as a result, FDA has to reprioritize within existing resources and risk not meeting existing or current responsibilities," he said at a Food and Drug Law Institute conference. The provision applies to petitions brand drug companies typically file when a generic drugmaker seeks approval of a low-cost copycat of the brand.

While some petitions raise safety and legal issues, lawmakers were concerned many were frivolous and filed with the sole intention of delaying generic drug approval while FDA takes months and sometimes years to respond to the petition. The overhaul measure requires FDA to respond to the petitions in 180 days, a timeframe von Eschenbach called "a substantial decrease" from the agency's average response time.

After the speech, he refused to expand on how the agency is reprioritizing or how much the additional effort will cost. FDA's associate general counsel, Gerald Masoudi later elaborated on some of the ambiguities in the law, which surrounded the petition provision and were mainly extremely technical in nature relating to what happens if the agency misses the 180-day deadline, evidence in court cases compiled after the deadline and petitions filed before the law passed.

FDA is moving steadily on other provisions in the bill, including one of the highlights of the legislation aimed at better balancing the agency's focus on approving drugs with consumer experience with drugs once they are commercially available.

FDA released a list of 16 approved drugs Wednesday that already take special precautions and must submit risk mitigation proposals to adhere to the new law by Sept. 21. The bill instructs FDA to use its discretion to determine new drugs that need risk mitigation strategies as part of their approval applications.