January 30, 2020
The following quote is attributed to Sally Choe, Ph.D., director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research:
“Today, the U.S. Food and Drug Administration is making critical updates to our policy for prioritizing the review of abbreviated new drug applications (ANDAs) to advance the public health, efficiently allocate limited agency resources and ensure fairness to applicants, which reflects the FDA’s longstanding practice to prioritize the review of ANDAs that would have the greatest potential impact on public health, if approved.
“Under the previous prioritization policy, 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.
“This practice strained the agency’s limited resources and did not support the agency’s goal of ensuring that ANDAs for those drugs with the greatest potential impact on public health are prioritized.
“The changes being announced today will allow the FDA to focus its priority review resources on those submissions that are most likely to have a meaningful impact on generic drug access, potentially lowering costs by expediting the availability of safe, high-quality, effective generic medicines in areas of the market with limited competition.”
- The Manual of Policies and Procedures (MAPP) 5240.3, Prioritization of the Review of Original ANDAs, Amendments, and Supplements (“Prioritization MAPP”) describes how the FDA prioritizes the review of ANDAs, amendments and supplements. The FDA may grant an ANDA submission a shorter goal date or an expedited review, as defined in the Prioritization MAPP, if the ANDA meets a public health priority identified in the MAPP, known as a prioritization factor.
- Today’s revision updates the MAPP’s prioritization factors and procedures, including changes to how the agency will prioritize submissions in the absence of an explicit request for priority review, modifications to the prioritization factors under which the agency will prioritize supplements, and clarifications and modifications to factors under which the agency will prioritize original ANDAs, including changes to the factors regarding submissions from “first filers” and other applications with a paragraph IV patent certification, which is a generic applicant’s assertion that the brand-name product’s patents listed in the Orange Book are invalid, unenforceable or will not be infringed by the proposed generic product.
- Under the previous version of the MAPP, the FDA prioritized submissions from first filers and from applicants with paragraph IV certifications, even though the applicants’ drugs would not be able to come to market for years due to a patent, 30-month stay, or exclusivity blocking final approval. This practice strained the agency’s limited resources and did not have a meaningful impact on generic drug access. This MAPP revision will allow the FDA to focus its limited priority review resources on submissions that are more likely to lead to approval of a product that will be marketed and made available to consumers, meaningfully impacting generic drug access.
- This MAPP only applies to ANDAs and is separate from the FDA’s priority review program for New Drug Applications.
- Manual of Policies and Procedures 5240.3, Prioritization of the Review of Original ANDAs, Amendments, and Supplements
- CDER Statement on updates to MAPP 5240.3, Prioritization of the Review of Original ANDAs, Amendments, and Supplements
- Webinar describing the latest revisions to the Prioritization MAPP
- FDA Infographic: Exclusivity and Generic Drugs
- Drug Competition Action Plan
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.