GPhA Still Wary Of Generic User Fees; Issue Tied To Waxman/Hatch Reform
This article was originally published in The Tan Sheet
Generic drug user fees should be considered only in the context of changes to Waxman/Hatch-related barriers to generic entry, the Generic Pharmaceutical Association told FDA at a Sept. 15 meeting on the Prescription Drug User Fee Act reauthorization process.
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FDA to hear stakeholder testimony Dec. 7 in Bethesda, Md., on what aspects of user fee program should be retained or changed and whether program should allow use of user fee funding to monitor post-approval drug safety. Agency also seeks input on how it can ensure PDUFA goals are met in wake of continued funding shortfalls and whether there should be flexibility in setting user fees to cover increased program costs. PDUFA legislative authority sunsets in September 2002; FDA held a similar public meeting last year (1"The Tan Sheet" Sept. 25, 2000, p. 8)...
The merger agreement between the National Association of Pharmaceutical Manufacturers and the Generic Pharmaceutical Association likely means generic drug user fees will not be a focal point of the PDUFA reauthorization process.
The Generic Pharmaceutical Industry Association and the National Pharmaceutical Alliance hope that by merging they will move closer to establishing a unified voice for the generic industry on the eve of legislative debates over user fees and Waxman/Hatch reform.