A top official for the Government Accountability Office suggested the FDA is not adequately inspecting foreign drugmakers, leaving the U.S. drug supply chain vulnerable as a growing number of drugs sold in the U.S. are made overseas, STAT reported.
Mary Denigan-Macauley, the GAO’s director of health care, voiced concerns to the Senate Finance Committee during a June 2 hearing about the FDA's practice of alerting foreign drugmakers in advance that it plans to conduct an inspection, something U.S. drugmakers don't receive.
The FDA is required by law to hold drugmakers in other countries to the same regulations as U.S. drugmakers, according to STAT.
The GAO has raised concerns over the FDA's foreign drug inspections in the past, considering it "high risk" for a decade.
During the COVID-19 pandemic, the FDA has stopped nearly all inspections of foreign drugmakers, STAT reported.
Judith McMeekin, the associate commissioner for regulatory affairs at the FDA, told the committee that the FDA has conducted more foreign inspections than domestic inspections every year since 2015. She also said that during the pandemic, the FDA is relying on "alternative inspection tools," to conduct inspections of foreign drugmakers, according to STAT.
Ms. McMeekin also said the FDA announces inspections of foreign drugmakers in advance to avoid a potential "waste of [FDA] resources," and to verify that the drugmaker being inspected is within FDA’s jurisdiction, STAT reported.
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