ARTICLE | Politics, Policy & Law

Surfing the GOP tidal wave

U.S. elections: More sympathetic for biopharma; but more reliance on user feesFDA, BIO, PhRMA dickering over longer review times in PDUFA V

November 8, 2010 8:00 AM UTC

While the biopharmaceutical industry's long-term agenda for the new Congress centers on PDUFA reauthorization, it will be at least a year before lawmakers turn their attention to the user fee legislation. In the near term, lawmakers will consider other issues importance to the life sciences community, ranging from budgets for science and oversight to implementation of healthcare reform.

For both sets of issues, Republican victories in last week's congressional elections cut two ways. With the GOP in control of the House, it is far less likely that PDUFA will become a vehicle for piling on new drug safety regulations, or imposing comparative effectiveness hurdles...