FDA Launches Pilot Program To Fast-Track Review Of Generic Drugs Made In U.S.

The U.S. Food and Drug Administration said on Friday it has launched a new pilot program to speed up the review process for generic drugs that are tested and manufactured entirely in the United States.

The program is designed to encourage companies to invest in domestic drug production and research by offering faster approvals for products made with U.S.-sourced ingredients and tested within the country.

Earlier this week, the FDA held a public meeting to discuss its broader efforts to support U.S. pharmaceutical manufacturing, including the PreCheck program, which aims to help set up high-priority drug facilities more quickly.

The FDA said these steps will help strengthen the U.S. drug supply chain and bring high-quality, U.S.-made generic drugs to market more quickly.

More than half of the pharmaceuticals distributed in the United States are made overseas, according to the health regulator.

As of 2025, only 9% of companies that produce the key ingredients in drugs – known as active pharmaceutical ingredients – are based in the U.S., compared to 22% in China and 44% in India, the FDA said.

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“Over-reliance 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,” said George Tidmarsh, Director of FDA’s Center for Drug Evaluation and Research.

“It also slows down reviews and costs taxpayers more money,” he added.

The FDA also noted many important studies used to approve drugs – including tests to show that generic drugs work the same as brand-name ones – are now often done outside the U.S., which is weakening the country’s ability to lead in drug research and development.

(Reporting by Siddhi Mahatole in Bengaluru; Editing by Shailesh Kuber)