Revised Policy from FDA Ensures Fairness and Protects Public Health

FDA published a revision to Manual of Policies and Procedures

Agency focused on generic drug applications

Editor’s Note: The following information was reviewed from the FDA’s website.

Last week, 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) if there are not more than three approved drugs (including the reference listed, or brand-name, drug). 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. 

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