WASHINGTON, D.C. (September 19, 2007) -- Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the following statement following passage by the House of Representatives of the reauthorization of the Prescription Drug User Fee Act (PDUFA) today:
“We are the pleased the House has voted to reauthorize PDUFA. 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.
“We encourage the Senate to pass this legislation before the current PDUFA agreement expires at the end of the month. The FDA will be forced to notify staff of the possibility of a reduction in force if this legislation is not signed into law in the next few days, and the loss of experienced reviewers would be detrimental to the biotech industry and the patients we serve.”
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.