FDA kicks off GDUFA III reauthorization process

FDA officials have launched the process for reauthorizing the Generic Drug User Fee Amendments (GDUFA) through an online meeting featuring presentations by members of industry and the public. More meetings are scheduled to determine the final form of FDA’s third GDUFA program. GDUFA II, which expires at the end of September 2022, sought to reduce the number of review cycles to approval and raise the number of generic drugs approved while adhering to safety and quality standards, said Maryll Toufanian, JD, director of the Office of Generic Drug Policy at FDA CDER’s Office of Generic Drugs. As a result, GDUFA II featured a new pre-abbreviated new drug application (ANDA) program. For GDUFA III, FDA needs to take additional steps to increase the number of first-cycle approvals, especially for complex generics, said Scott Tomsky, Teva’s vice president of regulatory affairs and genetics for North America. He cited a 2019 Government Accountability Office report finding a 12% average rate of first-cycle approvals, with “most applications taking at least three review cycles to reach approval.” Michael Kopcha, PhD, director of CDER’s Office of Pharmaceutical Quality, said: “After negotiations with the generic drug industry, FDA will send the agreed-upon recommendations to Congress, and Congress will hold hearings that include testimony from FDA experts, the generic drug industry, and other interested parties.”