Generic industry against giving fee breaks to firms setting up operations in the US

The generic drug industry told the US Food and Drug Administration (FDA) that it opposes waiving annual facility fees for the first three years for companies that establish manufacturing operations for finished generic drugs or active pharmaceutical ingredients (APIs) in the US during user fee negotiations.

The issue of fee waivers was one of the topics discussed under the Generic Drug User Fee Amendments (GDUFA IV) for fiscal years 2028 to 2032. The industry and FDA held a series of meetings on 14 and 21 January to address pressing concerns relevant to the industry.

During a meeting on 7 January, FDA proposed waiving annual facility fees for the first three years for companies that establish domestic manufacturing operations for finished generic drugs or APIs . (RELATED: FDA proposes waiving GDUFA facility fees for domestic manufacturers, Regulatory Focus 5 February 2026).

However, according to the 21 January meeting minutes, “Industry indicated that they support incentivizing onshoring of generic drug and API manufacturing but that they believe this proposal would not be an effective incentive because, among other things, it could result in increased fees for existing U.S. facilities in order to make up for the lost revenue, thereby potentially undermining existing domestic manufacturing operations.”

FDA acknowledged the industry's concerns and confirmed that they did not intend to counter these points. No agreement was reached on the issue during the meeting.

During the same meeting, industry also suggested that FDA revise its prioritization for Manual of Policies and Procedures (MAPP) to allow priority review for abbreviated new drug applications (ANDAs) and ANDA supplements that met two of the three criteria under its prioritization pilot.

In early October, FDA announced an ANDA prioritization pilot to support US drug manufacturing and testing for generic drug manufacturers. Under the initiative, ANDA applicants who meet three criteria are eligible for priority review. More specifically the criteria would require generic drug manufacturers to ensure their pivotal bioequivalence testing is conducted in the US, the finished dosage forms are made in the US, and their API is manufactured in the US.

Applicants can request the priority review by following the procedures outlined in FDA’s MAPP 5240.3 on priority review.

FDA said that it is receptive to the proposal regarding original ANDA submissions. However, officials clarified that the proposal would not work for supplemental submissions because of the high volume of such submissions and the large number of submissions that could qualify if only two of the three criteria were required.

During the 14 January meeting, one of the topics discussed was the industry's request to expand the agency's Pre-Launch Activities Importation Requests (PLAIR) program to prior approval supplements (PAS). Currently, the program is available only for ANDAs and NDAs.

In March 2022, FDA finalized a guidance to assist sponsors in submitting requests to import unapproved finished drugs prior to market launch of a pending new drug application (NDA), ANDA or biologics license application (BLA). The guidance outlines the procedures for making these requests under the PLAIR program and FDA’s timetable for approving requests. (RELATED: FDA finalizes guidance on pre-launch drug import policy, Regulatory Focus 3 March 2022).

The minutes said that FDA asked clarifying questions, and that no agreement was reached on this issue.

In another area, the industry also suggested aligning FDA’s postmarketing commitments program (PMCs) for generics more closely with the program for new drugs and biologics.

There are differences in the approach to PMCs between GDUFA and the new drug program under the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Act (BsUFA). PDUFA and BsUFA focus on safety surveillance, post-market trials for efficacy and risk management for new products, while GDUFA PMCs focus on quality, manufacturing, and bioequivalence of already approved active ingredients.

In its response, the FDA discussed the reasons for the differing approaches to postmarketing commitments between the GDUFA program and the PDUFA and BsUFA programs, and no agreement was reached.

14 Jan. minutes; 21 Jan. minutes

Generic industry against giving fee breaks to firms setting up operations in the US

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