Senators Propose Sweeping Changes to Generic Drug Oversight

Lawmakers on the Senate Special Committee on Aging are proposing significant changes to how the U.S. government ensures the quality of generic drugs. They cite a ProPublica investigation revealing the FDA allowed troubled overseas factories, primarily in India, to export drugs to the U.S. despite documented safety and quality failures. This practice, which began in 2013, allowed over 20 factories to continue sending products even after being banned. The FDA did not proactively track the impact of these imported drugs or inform Congress. Senators Rick Scott and Kirsten Gillibrand criticized the FDA's actions as a failure to protect public health. They are also calling for increased FDA testing of generics instead of relying solely on foreign manufacturers' assurances. The U.S. heavily relies on India for generics, with China supplying many key ingredients. The senators' report emphasizes bolstering domestic drug manufacturing and proposes the Department of Defense could create a federal buyer's market favoring U.S.-made drugs. This initiative aims to enhance drug supply chain security and reduce reliance on potentially adversarial nations. The report also advocates for greater transparency, requiring manufacturers to disclose the origin of drugs and their components on product labels.