Industry-FDA GDUFA III negotiations seek higher first-round approval rates

| 11 November 2020 |  By 

Moving on from the kickoff of the 21 July public hearing, the US Food and Drug Administration and representatives of the generics industry have begun substantive negotiations for the terms of reauthorization of the Generic Drug User Fee Amendments of 2017 (GDUFA).
After the first four rounds of negotiations between the US Food and Drug Administration (FDA) and the generics industry, representatives from industry and the FDA have honed in on the pre-facility correspondence program as a place where opportunities lie to decrease time to approval for generic drugs, though fine-tuning remains. (RELATED: FDA kicks off GDUFA III reauthorization process, Regulatory Focus 21 July 2020)
The first meeting, held on 17 September, set the ground rules for the virtual GDUFA III negotiations, and introduced FDA and industry representatives. In addition to the Association for Accessible Medicines, industry also had representation from the Bulk Pharmaceutical Task Force and the Pharma and Biopharma Outsourcing Association present at the closed-door negotiations. Though FDA publishes summaries of the meetings in the form of minutes on its website, specifics are not available to the public.
Minutes from the first meeting revealed that all involved would like to find a way to up the number of first cycle approvals; better transparency and communication between FDA and industry was another common goal.  
On 1 October, representatives from FDA and industry came together again with some specific proposals to ease earlier approvals of generics. For industry, the focus was on pre-submission of facility correspondence as well as better transportation and communication. Industry also expressed support for using information requests and generally improving communication to up the rate of first-cycle approvals.
On the FDA side, the 1 October meeting saw the agency looking for timely responses to complete response letters that raise only minor issues, as well as looking to find ways to review amendments in response to facility deficiencies more efficiently. Like industry, FDA also focused on pre-submission of facility correspondence; the agency also saw opportunities to reduce applications that have data reliability issues.
The 15 October meeting brought industry and FDA together, with “considerable time” spent on sorting through the pre-submission facility correspondence program as it now stands. According to the meeting minutes, both sides sought a better understanding of “how the information submitted enables FDA to make a determination of whether or not an inspection is needed, and which information is most critical and Industry’s challenges with meeting these needs.”
The fourth and final meeting held to date involved more clarification of the proposals hashed out on 15 October. The ball is now in the court of industry, whose representatives will come together with a proposal to return to FDA “in the coming weeks.”  A 29 October meeting has been held, but minutes for that meeting were not available at press time.
GDUFA III minutes


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Tags: FDA, generics, US

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