BPTF Calls for Changes to GDUFA

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BPTF seeks changes in performance goals and fee payment schedule in GDUFA renegotiations.


The Bulk Pharmaceuticals Task Force (BPTF), an affiliate of the Society of Chemical Manufacturers and Affiliates, asked FDA at a June 15 public meeting to consider several changes to performance goals and the fee payment schedule prior to reauthorization of the Generic Drug User Fee Act (GDUFA).

“In our assessment, GDUFA will continue to benefit the generic pharmaceutical industry and its suppliers,” said Alan W. Nicholls, BPTF Chairman in a statement. “We also believe progress made in inspection parity between domestic and foreign facilities is a positive step in progressing the safety and quality of the U.S. drug supply chain. However, there are several aspects of GDUFA that have resulted in unintended consequences.”

BPTF noted that the organization is concerned the increase in foreign inspections has been at the expense of domestic inspections. A reduction in U.S. inspections could adversely affect API facilities with the best compliance histories, and half of U.S. manufacturers may not receive inspection within a 3-year cycle, which many foreign countries require of API manufacturers in order to reauthorize finished dosage form drug products containing the API, Nicholls said in the statement.


BPTF has asked that FDA consider a fee reduction for small businesses during GDUFA II negotiations. In addition, BPTF believes the original baseline cost estimate for GDUFA of $299 million was too high, based on user fee carryover of $277.5 million at the end of Year 2 of the program. Thus, BPTF is asking that user fees under GDUFA II be reduced to better align with actual needs of the agreed program.

Nicholls also shared BPTF’s concerns regarding facility fees while pending approval of drug submissions, excessive user fees for bulk pharmaceutical ingredients, and the facility fee/application fee split ratio.

Source: Bulk Pharmaceuticals Task Force (BPTF), an affiliate of the Society of Chemical Manufacturers and Affiliates