PDUFA NEGOTIATIONS: FDA FOCUSES ON IMPROVED DRUG SAFETY, RISK MANAGEMENT

The FDA is focusing on improved use of epidemiological data and assessment of risk management plans (RMP) as two of the touchstones of its ongoing Prescription Drug User Fee Act (PDUFA) negotiations, a high-ranking agency official said.

The FDA believes that improved drug safety is "front and center" among the agency's priorities over the next year, Scott Gottlieb, the FDA's deputy commissioner for medical and scientific affairs, said at a June 28 conference. In an effort to improve drug safety, the FDA, it its negotiations with Congress on reauthorizing PDUFA, is seeking more user fees to purchase epidemiological databases and to develop a strategy for amending RMPs. PDUFA expires Oct. 1, 2007.

Those initiatives will not come cheap. It can cost the agency $7 million to $10 million to purchase four to five data sets from health insurers, and developing guidance documents is a multimillion dollar undertaking, Gottlieb said.

Having epidemiological data allows the agency to better predict the kinds of problems a drug can cause, Gottlieb told FDAnews. Knowing what the likely adverse events are allows the FDA to better focus its resources on clinical trials necessary to detect problems prior to approval, he said.

The agency also needs industry funds to make a major change in its RMP program. The FDA wants to develop a system to evaluate RMPs one to two years after a drug has been approved to assure that these plans are still effective in protecting patients' safety, Gottlieb said.

The agency does not want to have "a static program" in place. As circumstances change, the FDA wants to be able to adjust the RMPs to ensure safety. This announcement comes weeks after Gottlieb warned that the agency might be overusing RMPs. (http://www.fdanews.com/did/5_127/)