If you are, or plan to be a sponsor of a Generic ANDA, do not let this slip by you. The FDA on January 30, 2020 revised its Manual of Policies and Procedures (MAPP) 5240.3, Prioritization of the Review of Original ANDAs, Amendments, and Supplements to make changes to the prioritization scheme for the review of ANDAs. The Agency says: “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 summary of the changes can be found here , while the new MaPP can be found in its entirety here.
The topics of the specific changes include:
Requests for priority review – you must request a priority review unless the application falls into one of the three specific categories previously listed in the original MaPP (i.e. drug shortage, public health emergency, or not more than 3 approved drugs including the RLD. “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that “approved drug products” includes both active and discontinued products, unless the approval is voluntarily withdrawn under 21 CFR 314.150(c), with a published Federal Register notice.”). While an applicant does not need to request a priority review for those specific categories of products, FDA recommends that applicants request priority review even for those applications that cover those situations.
Supplements – it does not seem like the major criteria have changed (public health emergency or shortage, specific legal requirements and extraordinary hardship on the applicant; however, the litany of other criteria for prioritization seem to be included in other language that may be non-specific to supplements as they were in previous versions. To me, it is not entirely clear, based on the layout and wording of the revised MaPP.
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.” The Agency notes it will not prioritize review of all first-to-file applicants over the entire review of the application (i.e., multiple review cycles unless the application appear to meet the above requirement). Please read the detail of this in the revised MaPP as it is situational in nature.
Submissions for which final approval is dependent on the expiration of a patent or new drug application exclusivity – prioritization of applications for non-complex drugs will be prioritized if the ANDA is submitted between 24-36 month prior to the last applicable exclusivity or patent expiration and will do the same for complex generics if submitted if between 36 and 48 months before the last exclusivity or patent expiration. This will keep the FDA from expending resources to prioritize applications that are submitted long before patents or exclusivity could permit marketing. One example was tamoxifen that was first submitted (I believe) something like 13 years before patent expiration.
Submissions for sole source drug products – the Agency will continue to prioritize ANDA for sole source products however the MaPP clarifies that the sole source can be an ANDA product.
Don’t skip reading this revised MaPP as there are lots of tidbits of information your firm should digest.