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…
