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Experts warn U.S. dependence on foreign active ingredients contributes to shortages and counterfeit risk
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Summary
Witnesses and members said reliance on APIs made in China and India, limited domestic production and FDA review capacity have contributed to persistent shortages in essential drugs and increased vulnerability to counterfeit or contaminated imports.
The committee heard testimony that the United States’ heavy reliance on foreign production of active pharmaceutical ingredients (APIs) and limited domestic manufacturing capacity have contributed to drug shortages and increased the risk of counterfeit or substandard imports.
Former FDA Commissioner David Kessler said about 80% of APIs are produced in China and India and described the strategic vulnerability that creates. “We are at risk,” he said, urging investments to rebuild domestic scientific and manufacturing capacity.
Nut graf: Panelists linked supply‑chain concentration and shrinking regulatory workforce to current shortages; they recommended incentives for domestic manufacturing, better import screening and sustained funding for scientific research and inspections.
Members also raised the potential effect of tariffs on pharmaceutical costs and asked witnesses how staffing cuts at FDA’s Center for Drug Evaluation and Research (CDER) — where the committee heard more than 800 staff were recently cut — would affect the approval pipeline. Kessler and other witnesses warned that removing experienced reviewers risks longer approval times for new drugs and generics and could slow responses to shortages.
Ending: Lawmakers asked for briefings on FDA’s current inspection schedule and for options to incentivize domestic API and finished‑dosage manufacturing; several called for restoration of scientific funding and workforce investments to maintain competitiveness against China in the natural sciences.
