WASHINGTON, D.C. (September 21, 2007) -- Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the following statement regarding Senate passage of the reauthorization of the Prescription Drug User Fee Act (PDUFA):
“We are pleased that the House and Senate have voted to reauthorize PDUFA so this important legislation can finally be signed into law. The final package will help enhance and improve drug safety while providing the resources necessary for the Food and Drug Administration (FDA) to continue the efficient and comprehensive review of new drugs and biologics.
“This legislation provides the FDA with the enhanced capacity for drug evaluation with greater transparency and consistency and an active post-market surveillance system to better elucidate the benefits and risks of drugs and biologics. The legislation also takes steps to advance the Critical Path Initiative and provides important incentives for pediatric research.”
Since its inception in 1992, PDUFA has provided FDA with the resources necessary to review more than 1,100 new medicines, and to reduce review times for innovative drugs and biologics, providing patients and doctors with earlier access to breakthrough treatments.
BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and 31 other nations. BIO members are involved in the research and development of healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the annual BIO International Convention, the global event for biotechnology. www.bio.org