The race to nowhere

WASHINGTON - In a race that Biotechnology Industry Organization President Carl Feldbaum likens to the proverbial match between the tortoise and the hare, FDA reform and reauthorization of the Prescription Drug User Fee Act (PDUFA) is moving forward in the House but remains stuck inches from the finish line in the Senate. The House Commerce Committee, fixated on Medicare and Medicaid issues throughout the summer, started work on FDA reform much later than the Senate but it might pass legislation first, Feldbaum said.

The House Commerce Committee's health and environment subcommittee last week unanimously endorsed amendments to three FDA bills: H.R. 1411, the Prescription Drug User Fee Reauthorization and Drug Modernization Act of 1997; H.R. 1710, the Medical Device Regulatory Modernization Act of 1997; and H.R. 2469, the Food and Nutrition Information Reform Act of 1997. The full committee is scheduled to consider the bills this week and the full House could vote as early as next week...