FDA officials offer advice for successful suitability petitions

US Food and Drug Administration (FDA) officials discussed how the generic drug industry can improve the quality of their suitability petitions and avoid rejections as part of the agency’s commitment to conduct more timely reviews of these petitions at the Generic Drug Forum sponsored by FDA’s Small Business and Industry Assistance (SBIA) Program on 10 April. The meeting was held virtually and on-site in Bethesda, MD.

Officials are discussed the agency’s criteria for deeming certain petitions high-priority and first to review.

Suitability petitions, which were established under the 1984 Hatch-Waxman Act, are proposed by sponsors that want to submit an application that differs from the reference listed drug (RLD) in terms of the drug’s strength, dosage form, route of administration, or for changes in an active ingredient in a fixed combination drug product. Sponsors must get FDA approval of these petitions before submitting abbreviated new drug applications (ANDAs).

The law specified that FDA is required to either approve or reject these petitions within 90 days of receiving them. However, FDA has not been able to meet these goals: In FY 2023, FDA had 115 petitions pending a substantive response from FDA that went beyond 90 days.

To address this backlog and ensure FDA comes closer to meeting these deadlines, the Generic Drug User Fee Amendments (GDUFA III) set new goals for FDA's response to suitability petitions. FDA's goal on responding to suitability petitions within the goal timeframe scales from 50% in FY2024 to 90% by FY2027, with a cap on the total number of petitions the agency will be held to responding to in each year. (RELATED: GDUFA III commitment letter details coming changes to FDA’s generic review program, Regulatory Focus 2 November 2021). GDUFA III specifies that these submissions must be reviewed within six months after FDA completes completeness assessments.

How agency determines high priority petitions

FDA’s Arlene Figueroa, regulatory counsel for the Office of Generic Drugs (OGD), said that FDA will assign high priority to those petitions that can mitigate or resolve a drug shortage, prevent future shortages, or if they address a public health emergency. If these petitions are proposed for a new strength of a parenteral product, high priority will be assigned if the new strength can help in eliminating waste or mitigate the number of vials needed per dose. Lastly, high priority is accorded to those petitions that are subject to special review programs under the President’s Emergency Plan for AIDS Relief (PEPFAR).

To increase chances of getting petitions approved, Rosanne Pagaduan, a supervisory general health scientist for OGD, recommended that sponsors submit the following additional or supplemental information to support their petitions:

Proposed labeling showing all the differences in prescribing information from the RLD;
If there is a proposed change in strength, providing a description of the proposed product covering the tablet color, shape, size and imprint code;
Applicants should submit proposed carton labeling and container labels, if available.

For petitions requesting a different active ingredient in a fixed-combination product, applicants should:

Provide a description of any differences in the clinical safety or efficacy that may be seen with the proposed active ingredient compared to the active ingredient in the RLD;
Verify whether dosing of the product will change as a result of substituting the active ingredient.

Pagaduan said the reasons these petitions are not approved is if the application failed to investigate the impact of the route of administration, dosage forms, or strengths on the safety and effectiveness of the product. Another reason for denial is if the proposed changes from the RLD would jeopardize the safe or effective use of the product to necessitate significant labeling changes to address the newly introduced safety or effectiveness problem.

Lastly, Pagaduan suggested that applicants check the Orange Book to ensure that the NDA has been approved for the drug proposed in the petition; applicants should also ensure that the RLD has not been discontinued or withdrawn for safety or effectiveness reasons.

Generic Drugs Forum

FDA officials offer advice for successful suitability petitions

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