On January 13, FDA announced it completed recommendations for three user fee programs. HHS Secretary Kathleen Seblius sent the recommendations to Congress the same day as the announcement. The three programs include the fifth authorization of the Prescription Drug User Fee Act (PDUFA V), as well as new user fee programs for generic drugs and biological products.
The user fees are paid by manufacturers ("users") to help fund FDA's drug approval process and support about half of FDA’s operating budget; the other half comes from Congressional appropriations. FDA’s PDUFA V recommendations include improvements to REMS that APhA supports and advocated for at FDA’s public hearing in November 2011. For more information, read our pharmacist.com article.
January 25, 2012