July 9, 2012
Obama Signs FDA User Fee Legislation into Law
On July 9, 2012, President Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law. The legislation funds reviews of innovator drugs, generic drugs, medical devices and biosimilar biologics. It also includes the reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA).
The 1/6 fee enjoyed by PET drug manufacturerswas maintained in the Prescription Drug User Fee (PDUFA) and the Generic Drug User Fee (GDUFA) legislation includes an exemption for PET Drugs. The final legislation includes a mandate to report on illegal activities of internet pharmacies which could result in additional legislation governing Valid Prescriptions. The report is due within one calendar year; SNM will continue to monitor activities in this area.
For more information, please click on the FDASIA website.