Regulatory Beat: Multiple Issues Challenge Biotech Industry in 2007

Democrats are back on top in the Congress and are mapping a broad agenda for change. Prescription drug pricing, medical product safety, and access to treatments are high on the priority list. Manufacturers will be on the hot seat answering questions about patent policies, high-risk products, and why new biotech therapies cost so much. However, the real challenge will be gaining approval of a bill to reauthorize the Prescription Drug User Fee Act (PDUFA) before the program expires on September 30, 2007. Such legislation would renew user fees for medical devices and continue the pediatric drug exclusivity program.

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