FDA Proposes Additional User Fees, Undertakes to Improve Postmarket Safety
Last week, the FDA released a preliminary proposal to increase user fee collections by $87.4 million to enhance postmarket surveillance of drugs, drug development and review of television advertising. The proposal will only take effect if the FDA ultimately submits the proposal to Congress and Congress, reauthorizing the FDA's Prescription Drug User Fee Act (PDUFA), adopts the FDA's recommendations.
The FDA intends to allocate $29 million of the increase to postmarket surveillance, allowing the FDA to, among other measures, hire an additional 82 employees, and $6.2 million to fund review of direct-to-consumer advertising, allowing the agency to hire 27 new employees. An additional 4.6 million would fund the implementation of the guidance for the FDA's reviewers, and $4 million would be spent on the shift to an "all-electronic environment."
In addition to increasing the user fees, the FDA also recommends that Congress eliminate the statutory provision that allows the FDA to use PDUFA fees only during the first three years after a product receives FDA approval.
The Federal Register Notice is available online. The FDA will hold a pulic meeting on February 16, 2007, to present its proposals. Comments are due on February 23, 2007.
