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.
The concerns are expressed as the FDA has been issuing a steady stream of warning letters to foreign pharmaceutical producers, notably some of the largest companies in India, for a variety of quality control violations. The trend suggests foreign manufacturers remain problematic and the lawmakers questioned the extent to which the FDA is working harder to identify issues.
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One issue that has not been included in the dialogue on inspections is the number of MOU’s that US FDA has entered into in the last few years. Being able to accept the inspection reports of other national agencies might – I say “might” – allow the FDA focus on fewer targets, while still having more coverage.
One may argue that they should then do just as many, just different ones, but a risk-based approach is supposed to allow a more focused effort. It will be more than interesting to see how this plays out, and if it is done in a substantive way.