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Regulatory Focus™ > News Articles > 2020 > 10 > Generic drugmakers get revised MAPP for suitability petitions

Generic drugmakers get revised MAPP for suitability petitions

Posted 13 October 2020 | By Kari Oakes 

Generic drugmakers get revised MAPP for suitability petitions

A newly revised policy and procedure manual is available to generic drugmakers who wish to submit an abbreviated new drug application (ANDA) to the US Food and Drug Administration (FDA) for a formulation that differs in certain ways from the reference listed drug.
The Manual of Policies and Procedures (MAPP) published by FDA’s Office of Generic Drugs lays out how applicants can petition FDA  to submit an ANDA when the generic drug differs from the reference listed drug (RLD) in dosage form or strength, or in its route of administration.
These circumstances fall under section 505(j)(2)(C) of the Federal Food, Drug, & Cosmetic Act (FD&C Act); also included are situations when a drugmaker wishes to submit an ANDA for a fixed-combination drug that has one active ingredient that differs from the RLD product.
According to the MAPP, FDA will approve a suitability petition falling under these criteria unless one of three circumstances is present. First, FDA will deny the petition if it cannot adequately evaluate the safety and effectiveness of the proposed generic without the conduct of investigations that are beyond the scope of an ANDA.
Second, the suitability petition will be denied if a drug product is approved in a new drug application (NDA) for the same change that is requested in the petition. Third, FDA will not approve a suitability petition if the change would trigger pediatric studies as required under the Pediatric Research Equity Act.
Finally, according to the MAPP, FDA will not receive an ANDA “citing to a pending suitability petition (or to a suitability petition that was denied) because that ANDA would lack a legal basis for submission.”

The MAPP also lays out internal procedures for review of suitability petitions, which first go to a primary reviewer in the Division of Filing Review, who prepares a written petition addressing issues of eligibility and whether additional information is needed from the petitioner. Additional consults outside the Office of Generic Drugs may be sought at this point as well.
After a pass through the materials by a secondary reviewer, the Division of Filing Review program manager collates any requested consults and additional information requested by the primary reviewer. The MAPP outlines the workflow when outside consult requests occur, and gives guidance about how to resolve disagreements between the Division of Clinical Review and the Division of Filing Review regarding the disposition of the petition.
Two more reviewers in the Division of Legal and Regulatory Support review the public docket and the Orange Book, checks the status of the RLD, and edits the suitability petition response package as necessary.
Barring the need for a consult from FDA’s Office of Chief Counsel, the package can then proceed to the Office of Generic Drugs’ deputy director for clinical and regulatory affairs, or the designee for that position.

Tags: FDA, generics, US

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