GDUFA III negotiations turn to FDA financials
Representatives from the generics drug industry are refining priorities in their ongoing negotiations with the US Food and Drug Administration (FDA), as part of the reauthorization process for the Generic Drug User Fee Amendments of 2017 (GDUFA III).Negotiations for GDUFA III kicked off with a 21 July public hearing and an early set of meetings that set ground rules and found common ground in the importance of increasing the number of first cycle approvals.
These earlier meetings saw FDA putting forward some specific suggestions to speed generics approvals; another focus has been the existing pre-submission facility correspondence program. (RELATED: Industry-FDA GDUFA III negotiations seek higher first-round approval rates, Regulatory Focus 11 November 2020)
After mulling over FDA’s suggested remedies to decrease time to approval for generic applications, industry came forward with a response to the suite of FDA suggestions, according to the 29 October FDA-industry meeting minutes. That discussion carried forward to the 12 November meeting, held virtually like all of the other mid-pandemic GDUFA meetings. At that meeting, industry and FDA were “advancing toward finalization” of the proposals for facilitating earlier approvals.
FDA also proposed using “data driven models and time reporting” to predict resources needed for GDUFA III, with an eye to setting “a sound foundation for continued programmatic success.”
Other financial topics that arose during the 12 November meeting were how inflation adjustments should be taken into account, and the importance of FDA maintaining operating reserves sufficient to prevent interruption of any programs and maintain continuity.
These topics were picked up again and discussed in detail during the 19 November negotiation meeting, when “a significant portion” of the session was spent answering questions from industry about resource capacity planning, operating reserves, alternate ways to calculate inflation “to accurately account for program costs,” as well as upcoming limits on allowable fee expenditures.
During the 19 November meeting, discussion also turned back to the pre-submission facility correspondence program and imminent actions, according to the minutes.
FDA publishes summaries of the meetings in the form of minutes on its website, but details about the negotiations are not available to the public.
GDUFA III negotiation meeting minutes