In This Section
Generic Drug User Fees
Background
The Food and Drug Administration (FDA) issued a request for comments on a Generic Drug User Fee Program in the Federal Register (Vol. 75, No. 152) on August 9, 2010. The FDA believes a user fee program could provide necessary supplemental funding to allow for the timely review of applications.
SNMMI supported the development of the Generic Drug User Fee Program, but requested the FDA consider the impact on academic and commercial producers of PET radiopharmaceuticals. We suggested the agency utilize the fee structure and exemptions established for PET drugs under the Prescription Drug User Fee Act (PDUFA).
Current Status
FDA User Fee legislation was enacted into law; the exemption for PET drugs was included. President Obama signed the bill into law on July 9, 2012.