FDA revises generic drug application prioritization policy to ensure fairness to applicants, efficiently allocate limited agency resources, and protect the public health

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FDA revises generic drug application prioritization policy to ensure fairness to applicants, efficiently allocate limited agency resources, and protect the public health

Today, the FDA took action to encourage generic drug development and increase generic drug access by publishing a revision to MAPP 5240.3, Prioritization of the Review of Original ANDAs, Amendments, and Supplements (the “Prioritization MAPP”). This MAPP describes how the review of original abbreviated new drug applications (ANDAs), ANDA amendments, and ANDA supplements are prioritized for review. As we implemented the Prioritization MAPP under the first two years of the second iteration of the Generic Drug User Fee Amendments (GDUFA II), we determined that roughly one half of all ANDA submissions received were designated as priority applications. This level of inclusion strained the agency’s limited resources and did not support the agency’s goal of prioritizing review of applications for drug products with the greatest potential impact on the public health. We are revising the MAPP to better meet this critical goal and have posted a pre-recorded webinar describing these revisions. In an effort to protect the public health, efficiently allocate limited agency resources, and ensure fairness to applicants, we have refined the MAPP’s prioritization factors and requirements. The specific changes include: Requests for Priority Review FDA will only prioritize review of a submission if an applicant makes an explicit request for priority review, except in limited circumstances. Absent an explicit request for priority review from an applicant, FDA will initiate priority review of an ANDA only if the drug product relates to (1) drug shortage; or (2) public health emergency; or (3) if there are not more than three approved drug products (including the Reference Listed Drug). Applicants can still request priority review for any of the prioritization factors. Supplements FDA will prioritize review of supplements that (1) are related to drug shortage or public health emergency; (2) are subject to statutory mandate or other legal requirement; or (3) where a delay would impose an extraordinary hardship on an applicant. Submissions for Drug Products with Not More than Three Approved Drug Products FDA will continue to prioritize submissions for which there are not more than three approved drug products (including the Reference Listed Drug (RLD)) listed in the Orange Book. The MAPP now clarifies that “approved drug products” includes both active and discontinued products.  Applications Containing a Paragraph IV Certification FDA will now prioritize review of ANDA submissions with a paragraph IV certification that become eligible for approval during the review cycle, irrespective of whether the applicant is a first filer or subsequent filer, if the submission will be ready for final approval at or before the goal date for that submission. With this MAPP revision, FDA will no longer prioritize on the basis that upon original submission, an ANDA contains a paragraph IV certification, is submitted on the first day that any valid paragraph IV-containing application for the drug in question is submitted, and is received as substantially complete (i.e., submissions that have “first filer” status). Submissions for Which Final Approval Is Dependent on the Expiration of a Patent or New Drug Application Exclusivity FDA will now prioritize submissions for noncomplex products that are dependent on the expiration of a patent or New Drug Application exclusivity period if the original submission is submitted between 24 and 36 months prior to the expiration of the last applicable patent or exclusivity period. FDA will also now prioritize submissions for complex products (as defined in the GDUFA II Commitment Letter) that are dependent on the expiration of a patent or New Drug Application exclusivity period if the original submission is submitted between 36 and 48 months prior to the expiration of the last applicable patent or exclusivity period. FDA will prioritize submissions under this factor if there are not more than three approved drug products (including the RLD) listed in the Orange Book. Submissions for Sole Source Drug Products FDA will continue to prioritize sole source drug products for which there is only one approved product listed in the Orange Book. The MAPP now clarifies that, for purposes of this prioritization factor, the one approved product is an ANDA. The agency revised this MAPP as part of the Drug Competition Action Plan, which seeks to expand access to safe, high quality, effective generic medicines that can help consumers lower their health care costs.

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