[co-author: Kylie Snow]*
On October 3, 2025, the U.S. Food and Drug Administration (FDA) unveiled a pilot prioritization program that provides for accelerated review of abbreviated new drug applications (ANDAs) for generic companies that test and manufacture their products in the United States.[1] The aim of the program is to “spur and reward investment in U.S. drug manufacturing and research and development and strengthen the domestic pharmaceutical supply chain….”[2] According to the FDA, “[m]ore than half of pharmaceuticals distributed in the U.S. are manufactured overseas[,]” and “only 9% of API manufacturers are in the U.S., compared to 22% in China and 44% in India.”[3]
In general, in order to demonstrate that its ANDA qualifies for the pilot program, a generic company must submit a priority review request with its original ANDA submission. Under limited circumstances, a generic company may submit a priority review request as part of an amendment or supplement to its original ANDA submission. [4],[5] In either case, a priority review request must demonstrate each of the following:
- Either pivotal bioequivalence testing was conducted in the United States, or the ANDA qualifies for a waiver of bioequivalence testing;
- The finished dosage form manufacturer is located in the United States; and
- The API supplier is also located in the United States.[6]
When submitting a priority review request under this pilot program, a generic company must clearly specify that participation in the pilot program is the basis for the request.[7] In addition, companies must adhere to the procedures detailed in the FDA’s Manual of Policies and Procedures (MAPP 5240.3), “Prioritization of the Review of Original ANDAs, Amendments, and Supplements.”[8]
If the FDA determines that a submission is eligible for priority review under the pilot program, the application may receive a shorter goal date or expedited review.[9] If the FDA already assigned a goal date for a submission, however, the FDA will not shorten the goal date for that submission even if the FDA subsequently grants the submission priority review.
*CA Bar Admission Pending
[1] Food and Drug Administration News Release, FDA Announces New ANDA Prioritization Pilot to Support U.S. Generic Drug Manufacturing and Testing (October 3, 2025), https://www.fda.gov/drugs/drug-safety-and-availability/fda-announces-new-anda-prioritization-pilot-support-us-generic-drug-manufacturing-and-testing.
[2] Id.
[3] Id.
[4] Id.
[5] U.S. Food & Drug Admin., Manual of Policies and Procedures, Prioritization of the Review of Original ANDAs, Amendments, and Supplements, MAPP 5240.3 Revision 6, at 2 (Oct. 5, 2022), https://www.fda.gov/media/89061/download (“A priority review will be granted to an ANDA supplement or amendment to an ANDA supplement only if the supplement submission relates to a drug shortage, public health emergency, or certain government purchasing programs, is subject to a statutory mandate or other legal requirement, or FDA determines that a delay in making the change described in the supplement would impose an extraordinary hardship on the applicant.”)
[6] Supra, note 1.
[7] Id.
[8] Id.
[9] Supra note 5, at 3.
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