The US Food and Drug Administration (FDA) has announced a new pilot prioritisation programme for the review of Abbreviated New Drug applications (ANDAs) that aims to spur and reward investment in US drug manufacturing and Research and Development (R&D) and strengthen the domestic pharmaceutical supply chain by providing faster reviews for generic companies who test and manufacture their products in the US.

More than half of pharmaceuticals distributed in the US are manufactured overseas. Further, the US is reliant on overseas sources for Active Pharmaceutical Ingredients (APIs). As of 2025, only nine percent of API manufacturers are in the US, compared to 22 percent in China and 44 percent in India. In addition, pivotal studies for drugs, including bioequivalence testing for generic drugs, are increasingly conducted outside the US, weakening the US’s pharmaceutical R&D infrastructure.

Dr George Tidmarsh, MD, PhD, Director—Centre for Drug Evaluation and Research, FDA, said, “Ensuring that Americans have access to high-quality, safe and effective generic medicines is critical to public health. Overreliance on foreign drug manufacturing and testing creates risks both to national security and patient access, and undermines investments in US research, manufacturing and production. It also slows down reviews and costs taxpayers more money, as these foreign research and testing sites must be inspected by FDA, and foreign inspections take more time to prepare for, and are more expensive to conduct than domestic inspections. This pilot prioritisation programme can help ensure that Americans have a strong and resilient domestic drug supply, and also reflects the Trump Administration’s unwavering commitment to revitalising American industry and providing American consumers affordable access to needed medications.”

Earlier this week, FDA hosted a public meeting titled “Onshoring Manufacturing of Drugs and Biological Products” on FDA’s PreCheck programme, which introduces an innovative two-phase approach to accelerate the establishment of high-priority new pharmaceutical manufacturing facilities in the US and strengthen the domestic pharmaceutical supply chain. At that meeting, FDA heard from stakeholders about how incentives such as faster reviews could spur additional investment in US manufacturing and R&D.

This ANDA prioritisation pilot represents a further step FDA is taking to incentivise US generic drug manufacturing and testing. Under this pilot, ANDA applicants who conduct any required bioequivalence testing in the US and whose products are made in the US using exclusively domestic sources for APIs are eligible for priority review. Applicants can request this priority review by following the procedures outlined in FDA’s Manual of Policies and Procedures (MAPP) 5240.3, Prioritisation of the Review of Original ANDAs, Amendments, and Supplements (“Prioritisation MAPP”) and referencing this pilot programme as the basis for prioritisation. Applicants should provide information with their priority review request to demonstrate that their ANDA qualifies for the pilot (i.e., that either the pivotal bioequivalence testing was conducted in the US or that the ANDA qualifies for a waiver of bioequivalence testing; that the finished dosage form manufacturer is located in the US, and that the API supplier is located in the US).

Prioritising this additional category of ANDAs is expected to expedite the availability of high-quality, US-made generics for American consumers.