The Senate Special Committee on Aging proposed new reforms to strengthen oversight of foreign-made generic drugs, linking the effort to findings from a recent ProPublica investigation, according to an Oct. 27 report from the news outlet.
Committee Chair Sen. Rick Scott and ranking member Sen. Kirsten Gillibrand criticized the FDA for allowing more than 20 overseas drug factories — many based in India — to continue exporting medications to the U.S. after being banned over quality issues. The committee’s report, published Oct. 20, said the FDA did not notify Congress or the public about the exemptions, which have been in place since 2013.
The lawmakers called on the FDA to increase drug testing and notify hospitals and group purchasers when such waivers are granted. India supplies about half of all generic drugs used in the U.S., and many active ingredients originate from China, according to the report.
The committee report also proposed labeling changes to disclose the country of origin for drugs and ingredients, and recommended that the Defense Department lead a federal effort to prioritize domestically manufactured medications.
The FDA said the exemptions were intended to prevent drug shortages and required third-party quality testing by manufacturers, according to an Oct. 27 ProPublica report.
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