Senate Committee Presses Pentagon Over FDA Import Exemptions
The U.S. Senate Special Committee on Aging is raising concerns about FDA’s handling of foreign drug manufacturing violations and how those decisions could affect military readiness and national security. In a 2/18 letter to Defense secretary Pete Hegseth, chairman Rick Scott (R-FL) and ranking member Kirsten Gillibrand (D-NY) asked the Pentagon to explain whether it is purchasing drugs from foreign manufacturers that FDA has exempted from import bans despite documented quality violations.
The letter centers on reports that the agency, in an effort to prevent or mitigate drug shortages, has allowed certain medications or ingredients to enter the U.S. market from factories that were previously placed on import alert for failing to comply with federal manufacturing standards. According to the lawmakers, more than 150 drugs and ingredients have received such exemptions since 2013, many tied to facilities in China and India.
While FDA has authority to exercise enforcement discretion to address shortages, the senators said those exemptions could permit “substandard and potentially unsafe drugs” into U.S. commerce — including into federal purchasing streams that supply active-duty service members and their families.
The committee is seeking detailed information on whether the Department of Defense, including the Defense Health Agency and Defense Logistics Agency, is buying or stockpiling drugs from manufacturers that have received FDA import exemptions. Lawmakers also want to know how many of those products have no alternative FDA-compliant supplier.
The inquiry highlights the Defense Department’s reliance on generic medicines, which account for roughly 91% of prescriptions filled in the U.S. Many of those drugs depend on active pharmaceutical ingredients sourced from China and India.
The senators argue that FDA enforcement decisions — particularly the use of exemptions tied to foreign facilities with compliance lapses — intersect directly with national security when those same products are purchased for the military health system.
Beyond FDA enforcement discretion, the letter also frames broader geopolitical instability as compounding supply risks. The lawmakers pointed to China’s use of export controls in other sectors as evidence that pharmaceutical ingredients could be weaponized in future trade disputes.
Given China’s significant share of global API production, particularly for antibiotics, the senators asked how many days of drug inventory the Pentagon maintains and how an abrupt halt in exports would affect military readiness.
They also pressed the department to explain how it is implementing pharmaceutical supply chain mapping requirements included in the fiscal year 2026 National Defense Authorization Act — a measure aimed at improving visibility into where drugs and ingredients originate.
The letter urges greater transparency around drug sourcing, including country-of-origin labeling for finished pharmaceuticals and APIs. Lawmakers argue that clearer labeling would allow federal purchasers, TRICARE providers and patients to understand whether medications originate from facilities that have faced FDA enforcement actions.