FDA details policy on facility reclassification requests under GDUFA III

The US Food and Drug Administration (FDA) recently issued a manual of policies and procedures (MAPP) on the procedures it will follow in following up on reclassification requests following complete response letters (CRLs) to generic drug applications.

MAPP 5021.5, published on 12 June 2023, describes the policies used in the Office of Pharmaceutical Quality (OPQ), the Office of Compliance (OC) and the Office of Generic Drugs (OGD) to assess requests for reclassifying facility-based major CRLs from major to minor requests for original abbreviated new drug applications (ANDAs) and prior approval supplements (PASs).

The Generic Drug User Fee Amendments of 2022 (GDUFA III) allows drugmakers to request the reclassification of a facility-based “major” CRL amendment to a “minor” amendment, without being reinspected if they meet certain conditions.

According to Robert Pollock, a senior advisor with Lachman Consultants this provision of the law was prompted by concerns within the generic industry that they had to endure lengthy delays for a reinspection after getting an official action indicted (OAI) on a former inspection.

He said that “industry complained that it was difficult to get past a bad inspection that resulted in an OAI – that is the ultimate resolution once the facility was reinspected. The new process was put in place to assure that the compliance people and the reviewer in OPQ and OGD has a better communication connection to more easily resolve these issues.”

The MAPP, he said, “hints to the lack of communication between the review staff and compliance that has caused delay in applications moving forward in a timely manner.”

The memo states that “in accordance with the GDUFA III commitment letter, when OPQ and OGD staff receive an amendment that consists of a facility-only major-to-minor reclassification request and a response to the CR letter, they work collaboratively to determine whether to grant or deny the request.”

FDA will review a request for reclassification from major to minor if the following conditions are met:

The CR letter was issued on or after 1 October 2022, the GDUFA III implementation date;
The reclassification request is submitted with a CR letter response amendment in the submission;
The facility issue is the only major deficiency;
The CR letter’s major amendment classification is based on an observation from a surveillance inspection, including surveillance inspections conducted by a foreign regulator or where the information is shared under a mutual recognition agreement (MRA).

FDA will deny a request for reclassification request from major to minor if:

The facility deficiency was not based on a surveillance inspection;
The facility deficiency has not been adequately resolved for the subject drug;
The submission does into include the voluntary action indicated (VAI) or the NAI GMP classification letter issued by FDA.

The memo also details the roles and responsibilities of the various suboffices within OGD, OPQ, and the Office of Compliance in reviewing these requests.

The MAPP will go into effect on 27 June 2023.

CDER MAPP 5021.5

FDA details policy on facility reclassification requests under GDUFA III

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