Senate Letter Presses HHS on Foreign Generic Drugs
Senate Special Committee on Aging leaders are demanding answers from HHS on what they describe as serious national security and public health risks tied to America’s dependence on foreign pharmaceutical supply chains. In a 10/24 letter to secretary Robert F. Kennedy Jr., committee chair Rick Scott (R-Fla.) and ranking member Kirsten Gillibrand (D-N.Y.) warned that the U.S. remains heavily reliant on China and India for key drug components, including active pharmaceutical ingredients (API), key starting materials (KSM), and finished generic medicines. The senators noted that generics make up roughly 91% of all prescriptions filled in the U.S. each year.
The letter comes on the heels of a report, “Protecting Seniors’ Access to Essential Medications: Securing the Foreign Generic Pharmaceutical Supply Chain,” released last week and focused on what it calls America’s dangerous overreliance on foreign-made generic drugs (see story).
The lawmakers’ letter cited recent reporting that FDA has granted import exemptions for more than 150 drugs and ingredients since 2013 from foreign factories that had been placed on an import alert for substandard conditions. They argued that such exemptions are sometimes granted to prevent shortages but may put American consumers at risk.
The letter also raises concerns about geopolitical tensions, referencing China’s latest use of export controls as leverage in a trade dispute. The senators said similar restrictions on pharmaceutical products could expose the U.S. to dangerous shortages and hinder military readiness.
One additional vulnerability highlighted in the letter is market concentration. About 40% of generic drugs are manufactured by only one FDA-approved company, meaning any disruption could immediately cut off access for patients.
Scott and Gillibrand pressed HHS for detailed information by 11/30 on the readiness of the Strategic National Stockpile and a newer reserve of pharmaceutical ingredients known as the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR). The initiative was created in 2020 and recently prioritized through an August 2025 executive order directing HHS to stockpile API for 26 critical medicines.
The senators requested a full inventory of medicines and materials currently held in both stockpiles, a breakdown of the cost to expand SAPIR over the next five fiscal years, and clarity on how and when the federal government would release stockpiled ingredients to domestic manufacturers during a shortage.
The letter also asked HHS to identify which life-saving drugs would face immediate deficits if China or India halted exports and how long existing reserves could meet patient needs. The committee also questioned whether HHS has the staffing and internal coordination needed to manage worsening drug shortages.
Scott and Gillibrand framed the inquiry as essential to protecting older Americans, who are among the highest users of generics. “Inaction to address these supply chain concerns could be catastrophic,” they wrote. “We stand ready to support HHS in bolstering the nation’s public health preparedness and national security.”