02 October 2020 Vol 370, Issue 6512
By Charles Piller
Science02 Oct 2020 : 24-29
A Science investigation shows that FDA oversight of clinical trials is lax, slow moving, and secretive—and that enforcement is declining.
The U.S. Food and Drug Administration (FDA) oversees most clinical research in the United States, ensuring the integrity of trial data and the safety of study participants. This Science investigation, which evaluated FDA’s clinical trial enforcement for the past 11 years, suggests the agency’s enforcement of clinical research regulations is often light-handed, slow moving, and secretive—even when clinical trial practices were deemed dangerous or unlawful. The investigation, which included a review of nearly 1600 FDA inspection and enforcement documents for clinical trials, found that FDA rarely levels sanctions. When it does, follow-ups are either slow or neglected, and cases are frequently resolved based on unverified claims. And the agency has become less and less aggressive in its enforcement. It issued 99 and 36 warning letters for serious clinical trial transgressions during the first and last 3 years of the Obama administration, respectively, and only 12 were issued during the first 3 years under President Donald Trump. Disqualifications of egregious offenders also plummeted under Trump. The Science findings provide a cautionary tale as FDA oversees numerous fast-moving trials of vaccines and drugs for COVID-19.