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

The Food and Drug Administration announced Friday it is launching a new pilot program aimed at speeding up the review process for generic drugs that are both tested and manufactured entirely in the United States.

The initiative is designed to give drugmakers an incentive to keep production on U.S. soil by offering faster approval timelines for products made with American-sourced ingredients and trial data collected domestically.

Earlier this week, the agency held a public meeting to outline broader efforts to rebuild the country’s pharmaceutical manufacturing base, including its PreCheck program, which helps get high-priority facilities off the ground more quickly.

“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 the FDA’s Center for Drug Evaluation and Research. “It also slows down reviews and costs taxpayers more money.”

More than half of the pharmaceuticals sold in America are currently produced overseas, according to the FDA. Only 9% of companies that produce active pharmaceutical ingredients — the key building blocks of drugs — are U.S.-based, compared to 22% in China and 44% in India.

The FDA warned that heavy dependence on foreign labs has also shifted critical testing abroad, with many studies used to approve generics no longer conducted inside the United States. Officials say that undermines America’s role as a leader in medical research and puts patients at risk when overseas supply chains break down.