Anyone who has paid the least bit of attention to the doings of the U.S. Food and Drug Administration (FDA) in recent decades knows that accusations of “regulatory dereliction and corporate capture” are no exaggeration. In fact, where regulation and approval of drugs and biologics are concerned, the mainstream media—including outlets such as Reuters, Slate, The New Republic and PBS—are rife with stories of FDA misconduct.
The latest FDA critique comes not from the popular press, however, but from three high-powered experts affiliated with Harvard Medical School—who air their appraisal in the prestigious Journal of the American Medical Association (JAMA). With combined degrees in medicine, law, business and public health, the trio examines trends at the FDA since 1983, reviewing evolving regulatory standards and drug approval processes over a nearly four-decade period. The review reveals a troubling shift toward FDA use of “less data” to approve drugs and biologics—alongside an escalating reliance on pharmaceutical industry payments to cover the salaries of the very FDA reviewers issuing the approvals.