The FDA has launched a new pilot initiative to expedite review of abbreviated new drug applications (ANDAs) for generics manufactured and tested entirely within the United States, signaling a strategic move to strengthen domestic pharmaceutical production and supply chain resilience. The program is intended to incentivize companies to invest in U.S.-based manufacturing facilities and use domestically sourced active pharmaceutical ingredients (APIs), with the goal of reducing dependence on overseas suppliers and mitigating risks to drug access for American patients.
Under the pilot, applicants must demonstrate that both their finished dosage forms and APIs are produced in the U.S., and that required bioequivalence testing is conducted domestically. Companies qualifying for the program will receive priority review of their ANDAs—a benefit rarely extended to generics under traditional regulatory criteria. The FDA highlights that more than half of drugs distributed in the U.S. are currently manufactured abroad, with only 9% of global API production occurring domestically.
The move is part of a larger government push, reinforced by recent Executive Orders, to reshore pharmaceutical manufacturing as a matter of national security and public health policy.
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