n a public meeting held via webcast, officials of the US Food and Drug Administration (FDA) kicked off the process for reauthorizing the Generic Drug User Fee Amendments (GDUFA). The meeting, which included presentations by members of industry and the public, is the first of many that will shape the agency’s third GDUFA program.
GDUFA II, authorized in 2017, expires at the end of September 2022. The GDUFA II agreement had two major objectives in speeding access to generic drugs, said Maryll Toufanian, JD, director of the Office of Generic Drug Policy at CDER’s Office of Generic Drugs (OGD) at the meeting. The first was to reduce the number of review cycles to approval, and the second was to increase the number of generic drugs approved while maintaining safety and quality standards.
To that end, GDUFA II included a new pre-abbreviated new drug application (ANDA) program designed to smooth development and review of ANDAs for complex generics; new review goals were also set for priority ANDA submissions. Other updates in GDUFA II included more accountability and reporting requirements, a modification of the user fee structure, and provisions for small business relief.
GDUFA II by the numbers
Diving into the “numbers behind the numbers,” said Toufanian, reveals that the total number of communications with applicants exceeds 20,000. In all, 264 pre-ANDA program meetings have been held, with 113 pre-ANDA requests received in FY 2019 alone. “Use of the pre-ANDA meeting program continues to grow,” said Robert Lionberger, PhD, director of the Office of Research and Standards at OGD, adding that FDA has exceeded its GDUFA II goals in this area…