GDUFA IV: Negotiations address DMFs, internal consultations, imminent actions

Officials from the US Food and Drug Administration (FDA) and representatives from the generic drug industry met on 19 February as part of the negotiations for the fourth iteration of the Generic Drug User Fee Amendments (GDUFA) program. The topics addressed during the meeting included drug master files (DMFs), internal consultations, and imminent actions.

Most of the FDA's user fee programs, which include those for prescription and generic drugs, medical devices, and biosimilars, will expire on 30 September 2027 unless they are reauthorized by Congress.

Under GDUFA, certain DMFs can be reviewed by the FDA before the submission of abbreviated new drug applications (ANDAs) and prior approval supplements (PAS). One topic being discussed at the meeting was industry's request to expand the prior assessment of DMFs to include all DMFs.

During the meeting, FDA said the industry’s request to expand prior assessments to include all DMFs was “not feasible.” Instead, FDA offered to “clarify and standardize the process by creating a prior assessment cover letter template, presenting to industry on the process at least once per fiscal year, and by instructing DMF holders to request prior assessments using FDA Form 3938.”

The agency proposed expanding the criteria for prior assessments to include the following types of ANDAs and DMFs: planned ANDA submissions for which all patents and exclusivities will expire within 18 months of the planned submission date, DMFs that include a new domestic active pharmaceutical ingredient (API), and submissions of DMFs for complex APIs.

FDA also proposed to review a maximum of 12 prior assessments for DMFs in which a new domestic API source is added, and a maximum of 10 complex APIs that are submitted in DMFs. FDA said that prior assessment requests would be granted on a first-come basis.

Industry raised questions about the limit on the number of submissions allowed in specific categories, and how FDA could ensure equity among ANDA applicants. FDA expressed its willingness to consider changes to the proposed language in the upcoming commitment letter.

Another topic of discussion was requests within FDA for internal consultations on an application. Both industry and FDA are looking to improve the efficiency of reviews process by initiating earlier internal consultations.

“FDA indicated that, as industry requested, the review team will begin their assessment as soon as the receipt determination is made, and will strive to promptly send necessary consults that can be identified based on a threshold review of the ANDA, with a request that consult responses be provided within a timeframe that allows for incorporation of issues identified in the consult response into the DRL.”

FDA officials also clarified that it is not possible to identify all necessary consultations from a threshold review. A threshold review is the initial review of an application conducted by FDA to determine if it is complete.

Agency officials said that some information related to these consultations is only provided by applicants after the issuance of Information Requests (IRs) or Disciplinary Review Letters (DRLs). Also, the need for certain consultations “can only be identified once assessors have had the opportunity to substantively review relevant portions of the ANDA.”

The agency proposed developing draft guidance on good ANDA submission practices to allow for earlier consultations. Industry agreed that a guidance could be helpful and suggested that FDA also consider other methods of providing information such as recurring training for industry.

Under the proposed GDUFA IV provision known as imminent action, FDA can miss a goal date if, in FDA’s judgement, an approval or tentative approval of the application will occur shortly after. This provision will mitigate the need to add additional review cycles and delay approvals over minor issues.

Industry proposed to create a separate category for IA when a facility’s surveillance inspection is pending classification. “FDA indicated that it believes the agency’s separate proposal to address pending official action indicated (pOAI) alerts is the better option for addressing this issue.”

“Industry asked FDA to consider whether a 90-day extension from the goal date, with the use of IA if appropriate, could address pOAI alert issues as well,” FDA said.

Minutes

GDUFA IV: Negotiations address DMFs, internal consultations, imminent actions

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