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# FDA Clinical Trial Oversight Slipping: Report
- URL: https://www.fdaweb.com/fda-clinical-trial-oversight-slipping-report/
- Published: 2020-10-01T12:00:00.000Z
- Updated: 2026-09-14T16:31:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147787

A review of FDA inspection documents on the agency’s clinical trial oversight during the past 11 years shows enforcement is often light-handed, slow-moving, and secretive, according to the [journal ](https://www.sciencemag.org/news/2020/10/fda-s-own-documents-reveal-agency-s-lax-slow-and-secretive-oversight-clinical-research?ref=fdaweb.com)[*Science*](https://www.sciencemag.org/news/2020/10/fda-s-own-documents-reveal-agency-s-lax-slow-and-secretive-oversight-clinical-research?ref=fdaweb.com)*.* The review period of documents obtained under the Freedom of Information Act covered former president Obama’s administration and the first three years of president Trump’s term.

The *Science* article says oversight has been worsening under the Trump Administration. “The agency issued 99 ‘Warning Letters’ for serious clinical trial transgressions during Obama’s first three years in office, 36 in his last three years, and just 12 during the first three years under Trump,” it says. “It certainly looks like FDA is enforcing clinical trial requirements much less frequently, which is troubling for protecting subjects’ welfare and ensuring the validity of data for our medical products,” said **Patricia Zettler**, a former FDA lawyer who reviewed *Science*’s findings.

University of North Carolina social scientist **Jill Fisher** said she was troubled that when an FDA inspection exposed apparent mistakes, recklessness, or fraud in a trial, neither the agency nor the clinical investigators running the trial are obliged to notify participants. At the least, Fisher said, trial participants “should be told when the integrity of a research center running the study or its investigator is in question.”

*Science also* found that FDA rarely levels sanctions. Since 2009, FDA designated as “Official Action Indicated (OAI) ” about 4% of clinical trial inspections, which requires clinical investigators to correct serious, illegal, and potentially dangerous clinical trial problems. Often, OAI inspections were downgraded to “Voluntary Action Indicated,” according to the review.

“Under Trump, the number of FDA inspections per year has increased significantly, yet enforcement actions have nosedived,” *Science* reports. “About 6% of FDA inspections were classified as OAI during the Obama administration, although the proportion began to decline in his second term. During Trump’s first three years, however, OAI reports fell to less than 1% of the total. Even voluntary action designations declined sharply under Trump, whereas ‘no action’ inspections spiked. The agency disqualified an average of three investigators per year under Obama but just two total during Trump’s first three years.”

FDA is not disputing *Science*’s findings on OAIs and Warning Letters — but the agency said Trump-era policies were not a factor. “The number of Warning Letters can ebb and flow,” the agency told *Science*.