Monthly Archives: September 2011

Last week, the FDA released its long-awaited recommendations for the upcoming Prescription Drug User Fee Act (PDUFA) reauthorization of 2012. PDUFA authorizes FDA to collect user fees from drug companies that file new drug applications. In return for the fees, sponsor companies are guaranteed that their applications will be reviewed in a timely manner. Under this framework, FDA funding for drug approvals is not disrupted by the annual budget and appropriations process—which has become a bit of a political circus, given current pressures to cut back on government spending and reduce the federal deficit. Industry and beltway insiders have been buzzing that the package will likely pass through Congress without serious disruption. FDA has been in negotiations with key stakeholders such as PhRMA, BIO, and other stakeholders for over a year to sort out the technical details of the package. As proposed, the recommendations do not drastically change the drug approval process the way PDUFA did following the last reauthorization under FDAAA. A few key changes in the package include: