Foreign Factories, Risky Medications: The FDA Under Fire

Two U.S. senators, Rick Scott (R-Fla.) and Kirsten Gillibrand (D-N.Y.), are demanding that the FDA disclose which foreign drug manufacturers have been allowed to bypass import bans, citing serious safety concerns. A ProPublica investigation revealed that since 2013, the FDA granted exemptions to over 20 troubled factories, including a Sun Pharma plant in India, allowing more than 150 drugs or ingredients—including antibiotics, anti-seizure medications, and chemotherapy drugs—into the U.S. despite repeated quality violations.

The FDA justified the exemptions as necessary to prevent drug shortages, but the process was largely hidden from lawmakers, healthcare professionals, and the public. Investigations have uncovered contaminated drugs, unsanitary conditions, and destroyed testing records at some facilities. Decisions to grant exemptions were made by a small group of agency insiders, often overriding inspectors’ findings.

Senators argue this lack of transparency endangers patient safety, particularly for seniors. They have requested detailed information on exempted drugs, definitions of drug shortages, and market share data, with a deadline in mid-October. ProPublica used AI tools to compile a list of exempted drugs from archived FDA reports. Critics call for stronger domestic manufacturing and stricter oversight to ensure that unsafe foreign medications do not reach American patients.

Cenziper, D., Rose, M., & Dailey, K. (2025, September 19). “Unacceptable”: Prominent U.S. senators demand FDA provide names of troubled foreign drugmakers skirting import bans. ProPublica.