Senate Prescription Drug User Fee Act Mark-Up

On April 25, the Senate Health, Education, Labor and Pensions (HELP) Committee sent to the full Senate the Prescription Drug User Fee Act (PDUFA).  The legislation grants a five year reauthorization of FDA's user fee programs.  User fees help fund FDA reviews of prescription drugs and medical devices.  The measure would also create user fee programs for generic drugs and biosimilar products.

The panel debated at length but ultimately rejected an amendment offered by Senator John McCain (R-AZ) which would allow individuals in the U.S. to purchase drugs online from a list of approved pharmacies in Canada.

APhA sent a letter supporting the bill to the HELP Committee because it addresses drug shortages and would allow FDA to use the fees to improve and continue to work on issues important to pharmacists such as: risk evaluation and mitigation strategies (REMS), the Sentinel Initiative related to post-market surveillance, and pharmacogenomics.

Congress aims to have the user fee legislation signed into law by the end of June to avoid any potential delays that might occur when members of Congress are campaigning for re-election this year.

May 2, 2012