Senate Opens PDUFA Debate, Postpones Biogenerics Talks

Washington, DC (Apr. 30)-Less than two weeks after the Senate Health, Education, Labor, and Pensions Committee voted to reauthorize the Prescription Drug User Fee Act (PDUFA), the bill this week moved onto the Senate floor. The big surprise, however, is that the committee’s chairman, Sen. Edward M. Kennedy (D-MA) and supporter Sen. Michael B. Enzi (R-WY) decided not to bring with it the debate allowing the US Food and Drug Administration (www.fda.gov) to oversee and approve generic biologics. The senators have long vowed they would tie this provision with the PDUFA reauthorization.

The review and approval of follow-on biologics has been heavily debated among organizations such as the Pharmaceutical Manufacturers and Researchers of America (PhRMA, www.phrma.org), the Biotechnology Industry Organization (BIO, www.bio.org), and the Generic Pharmaceutical Association (GPhA, www.gphaonline.org) (see March 29 and April 12 editions of ePT) as well as among former FDA Commissioners.

With the omission of the follow-on biologics provision, the move toward authorizing PDUFA IV, to be in effect the next five years, retains its original intention of enabling FDA to monitor drug safety of marketed products with user fees collected from the pharmaceutical industry.