United States: FDA Revises Policies And Procedures For Prioritization Of ANDAs

On January 30, 2020, the U.S. Food & Drug Administration (FDA) issued a new Manual of Policies & Procedures (MAPP) concerning how it will prioritize internal review of abbreviated new drug applications (ANDAs), amendments and supplements.

Whether a submission qualifies for priority designation can mean a substantial difference in approval time. As the FDA explains, it "may grant an ANDA submission either a shorter review goal date or an expedited review" if the submission satisfies a public health priority (or prioritization factor) described in the MAPP.

This MAPP reflects an effort by the FDA to alleviate some of the administrative issues created by the prior version, released November 2017. According to Dr. Sally Choe—director of the Office of Generic Drugs in the FDA's Center for Drug Evaluation and Research—under the previous iteration of the MAPP, "roughly half of all ANDA submissions were designated as priority submissions, including many products that could not be marketed for several years as a result of blocking patents or exclusivities." The counterproductive result was that the FDA saw its resources strained, inhibiting its "goal of ensuring that ANDAs for those drugs with the greatest potential impact on public health are prioritized."

Among other things, the new MAPP makes some critical changes to the submission prioritization factors. For instance, the FDA will now prioritize submissions for noncomplex products "that are dependent on the expiration of a patent or a 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." Similarly, the FDA will also now prioritize submissions for complex products (i.e., those with complex active ingredients, formulations, routes of delivery or dosage forms) "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." Regardless, the FDA will only prioritize such submissions under this factor where there are not more than three approved drugs—including the reference listed/brand name drug—listed in the Orange Book.

In addition, with respect to supplements, the FDA explains that it will now prioritize review of ANDA supplements related to a drug shortage or public health emergency, subject to legal requirements or where a delay would impose "extraordinary hardship on an applicant." Further, for so-called "sole source drug products," the FDA will continue to prioritize the products for which there is only one product listed in the Orange Book. The revised MAPP clarifies that, regarding the "sole source" factor, the one approved product is an ANDA.

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