“The F.D.A. views any deviation from its high standards for developing or marketing drugs and devices as a potential threat to patient safety and public health,” Norris Alderson, the FDA’s associate commissioner for science, tells The New York Times. “We will take strong action against anyone who chooses to ignore or flout the legal requirements for the products we regulate.”
In a new report, the GAO found that more than half of the debarment proceedings in its review took 4 or more years, and factors contributing to these time frames included internal control weaknesses in the debarment process and competing priorities among responsible staff (read the report).
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