“Unacceptable”: Prominent U.S.... Note
ProPublica

“Unacceptable”: Prominent U.S. Senators Demand FDA Provide Names of Troubled Foreign Drugmakers Skirting Import Bans

Two U.S. senators are demanding the FDA account for allowing foreign drugmakers to bypass import bans, a practice exposed by a ProPublica investigation. The investigation revealed the FDA granted special passes to troubled manufacturers despite quality concerns. Senators Rick Scott and Kirsten Gillibrand expressed urgent concerns about the safety of drugs entering the U.S. from these factories. ProPublica found the FDA exempted over 20 foreign factories, allowing the import of over 150 drugs. The FDA claimed these exemptions prevented drug shortages, but kept the practice largely hidden. The senators fear potentially unsafe drugs are entering the market, especially affecting seniors. A former FDA inspector also reported "shortcuts and fraud" at substandard factories, undermined by these exemptions. The decisions to exempt drugs were made by a secretive group within the FDA, as Janet Woodcock stated in an interview. Senators requested detailed information about the exemptions, including a list of drugs.