December 28, 2006

Instead of the new regulatory authority being proposed by lawmakers and embodied in a recent study by the Institute of Medicine, the FDA actually needs money to improve the science of regulation, according to the agency's outgoing deputy commissioner for medical and scientific affairs.

For example, the FDA needs resources for new IT tools and applications to improve clinical trial designs and better evaluate biomedical information, Scott Gottlieb said in an exclusive interview Dec. 27.

The agency must have internal development teams to establish the best statistical and epidemiological tools for evaluating large data sets. That information would be invaluable for assessing the safety of proposed new drugs, he said. Currently the FDA must "beg, borrow and steal" to get the money for these efforts.

The answer lies in the ongoing Prescription Drug User Fee Act (PDUFA) negotiations, according to Gottlieb. The agency is currently negotiating with industry for the next round of fees and has received agreements for the agency to have greater control over the uses of these funds, and more funds targeted toward postmarket drug safety activities and IT, he said.

Gottlieb counts as one of his major accomplishments ensuring increased resources for the agency through greater use of user fees for drugs and devices. These fees are essential for the agency to improve the way it does its job, he said.