PDUFA IV Would Strengthen Drug Safety System, PhRMA CEO Says

While the FDA's recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) would cover the agency's needs, Congress should consider appropriating more funds so the agency does not rely so much on user fees, PhRMA CEO Billy Tauzin said.

The PDUFA IV recommendations include $150 million over the next five years for postmarketing drug safety, Tauzin said. The agency will use the money to hire 82 new employees for postmarketing safety review work. "Safety will be an ongoing, unlimited-by-time project," Tauzin said.

The FDA is focusing on upgrading its technology capabilities and moving to an active data collection system, making its risk communication efforts more effective and improving drug reviews, Tauzin said. The agency submitted its final PDUFA recommendations to Congress last week.

PDUFA IV would also fund reviews of direct-to-consumer (DTC) advertising, adding $6.2 million in user fees and 27 new employees to evaluate television advertisements. The FDA currently takes an average of 90 days to review one DTC advertisement, which discourages companies from participating in the review process, Tauzin said. However, he noted that all of PhRMA's member companies have voluntarily signed up to have the FDA review their DTC ads.

The recommendations address "all substantive needs the FDA identified" and incorporate suggestions from a report by the Institute of Medicine, Tauzin said.

Bills such as the "Enhancing Drug Safety and Innovation Act" also call on the FDA to increase postmarketing safety and regulate DTC advertising, but Congress must give the agency more funds to go along with more authority, Tauzin said. User fees make up so much of the agency's resources in certain departments that more appropriations are necessary, he added.

( http://www.fdanews.com/did/6_62/ )