STAT Plus: Lawmakers seek more info on how FDA inspects plants in China and India
Amid ongoing interest among Americans to import drugs from other countries as well as continuing concern about a spate of recalled blood pressure medicines manufactured overseas, House and Senate lawmakers have asked the FDA to explain how it protects the pharmaceutical supply chain. At the same time, a bipartisan group from the House wants the Government Accountability Office to review the FDA inspection program.
In separate letters sent late last week, the lawmakers cited recent news reports about ongoing manufacturing problems at companies in China and India, which account for the majority of the active pharmaceutical ingredients used in medicines that are shipped to the U.S. They also pointed to a 2016 GAO report that found FDA oversight of foreign facilities was lacking.
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