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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

[1/30/2020] Today, the U.S. Food and Drug Administration published a revision to Manual of Policies and Procedures (MAPP) 5240.3, Prioritization of the Review of Original ANDAs, Amendments, and Supplements. This update aims to efficiently allocate limited agency resources to areas where priority review is most likely to meaningfully increase generic drug access and ensure fairness to applicants.

The MAPP describes how the FDA prioritizes the review of abbreviated new drug applications (ANDAs), amendments and supplements. FDA may grant an ANDA submission either a shorter review goal date or an expedited review, if the submission meets a public health priority, or prioritization factor, identified in the MAPP. Today’s revision updates the MAPP’s prioritization factors and procedures. 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. Without an applicant’s explicit request for priority review, FDA will initiate priority review of an ANDA only if the drug product relates to (1) a drug shortage; or (2) a public health emergency; or (3) that the submission meets the requirements of section 505(j)(11)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Applicants can still request priority review for any of the prioritization factors. Even for the three above factors, FDA recommends that applicants request priority review if they believe their submission qualifies under one of the prioritization factors. 
  • Supplements
    FDA will prioritize review of supplements (1) related to a drug shortage or public health emergency; (2) subject to legal requirements; or (3) where a delay would impose an extraordinary hardship on an applicant. This allows FDA’s Office of Generic Drugs to prioritize the supplements that will have the greatest impact on generic drug access.   
  • 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 drugs (including the reference listed, or brand-name, drug) listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). The MAPP now clarifies that “approved drug products” includes both active and discontinued products, unless the approval is voluntarily withdrawn under 21 CFR 314.150(c), with a published Federal Register notice. 
  • Applications containing a Paragraph IV certification
    FDA will now prioritize review of certain ANDA submissions with a paragraph IV certification that become eligible for approval during the review cycle, whether or not the applicant is the first to file an ANDA, 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 all submissions from first filers over the entire course of review of ANDA. The agency does not believe that this revision to the MAPP increases the applicant’s risk of forfeiting 180-day exclusivity for failure to obtain tentative approval within 30 months after the day of original submission. Under the second iteration of the Generic Drug User Fee Amendments, applicants have the opportunity for multiple review cycles to correct any issues with their original ANDA in this 30-month timeframe and receive a tentative approval.   
  • 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 (NDA) 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 NDA 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 reference listed, or brand-name, drug) 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.  

For more information, see the updated MAPP. You may also view the prerecorded webinar describing the revisions.