FDA Announces New Domestic Generic Drug Fast-Track Review Program

FDA announced a new pilot program designed to provide faster reviews for domestically tested and manufactured generic drugs.¹

The program is part of a larger initiative to promote and reward domestic investments by pharmaceutical companies. The abbreviated new drug applications (ANDAs) are meant to strengthen the domestic pharmaceutical supply chain while also helping to get less expensive drugs to market sooner.

In a press release, director of FDA’s Center for Drug Evaluation and Research Dr. George Tidmarsh, MD, PhD, 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 U.S. 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 prioritization program can help ensure that Americans have a strong and resilient domestic drug supply and also reflects the Trump Administration’s unwavering commitment to revitalizing American industry and providing American consumers affordable access to needed medications.”

According to FDA, the United States relies on foreign sources for active pharmaceutical ingredients (APIs), with only about 9% of the materials being manufactured in the US. The agency states that China produces 22% of the APIs the US relies on, while India produces 44%.

In order for ANDA applicants to be approved, the products they produce must exclusively source their APIs from domestic sources.

This is just the latest move by FDA to promote domestic manufacturing practices.

In August, the agency announced a new program called FDA PreCheck,² which is designed to increase regulatory predictability and facilitate construction of domestic manufacturing sites.

At the time, FDA commissioner Marty Makary, MD, MPH, said, “Our gradual overreliance on foreign drug manufacturing has created national security risks. The FDA PreCheck initiative is one of many steps FDA is taking that can help reverse America's reliance on foreign drug manufacturing and ensure that Americans have a resilient, strong, and domestic drug supply.”

President Trump has made reducing pharmaceutical prices and increasing domestic manufacturing a priority of his administration. Aside from FDA launching these new programs, he has taken steps to make it more difficult for pharma companies to rely solely on imported goods to manufacture and/or distribute drugs in the United States.

Most recently, President Trump announced his intention to levy 100% tariffs on imported branded and patented pharmaceutical products. However, he carved out an exception for pharma companies who had officially begun (or broke ground) on domestic manufacturing sites. While the president initially set an October 1, 2025, deadline for the tariffs, he appears to have changed course.

While he hasn’t taken the 100% tariffs off the table, he also has yet to officially declare them. Instead, reports suggest that he’s using the tariffs as part of his negotiations with pharma companies. Pfizer, for example, announced that it made a deal with the White House to lower drug costs in the United States. While the specific details of the deal were not made public, it was revealed that the deal included a stipulation that would protect Pfizer from the tariffs for three years as long as it held up its end of the deal.

Sources

1. FDA Announces New ANDA Prioritization Pilot to Support U.S. Generic Drug Manufacturing and Testing. FDA. 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. FDA Announces New FDA PreCheck Program to Boost U.S. Drug Manufacturing. FDA. August 7, 2025. Accessed October 3, 2025. https://www.fda.gov/news-events/press-announcements/fda-announces-new-fda-precheck-program-boost-us-drug-manufacturing