Reauthorization of the Prescription Drug User Fee Act (PDUFA)

On behalf of the Biotechnology Industry Organization, I thank you for the opportunity to comment in support of the reauthorization of the Prescription Drug User Fee Act and discuss how we can ensure achievement of the goals envisioned under PDUFA, and make further refinements toward that end.

BIO represents more than 1,200 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products, thereby expanding the boundaries of science to benefit humanity by providing better healthcare, enhanced agriculture, and a cleaner and safer environment.

Innovation in health care - including new therapies, vaccines and diagnostics - has been and will continue to be central to an improved health care system and a key driver of economic progress. Biotechnology has created more than 200 new therapies and vaccines, including products to treat cancer, diabetes, HIV/ AIDS and autoimmune disorders. There are more than 400 biotech drug products and vaccines currently in clinical trials targeting more than 200 diseases. Recognizing that a reliable, science-driven regulatory environment fosters innovation, promotes economic competitiveness, and maintains high patient confidence in the integrity of medicines, BIO member companies have supported a carefully structured user fee program to help fund FDA’s human drug review activities.