FDA enforcement actions under Trump took a plunge and disqualifications of offenders plummeted, claims probe
The US Food and Drug Administration (FDA) oversees most clinical research in the country, ensuring the integrity of trial data and the safety of study participants, including most recently several high-stakes vaccines and drug trials for Covid-19. However, a new investigation by Science, which closely evaluated FDA’s clinical trial enforcement for the past 11 years, suggests that the agency’s enforcement of clinical research regulations is often light-handed, slow-moving, and secretive — even for cases where clinical trial practices were deemed dangerous or unlawful.
The FDA’s findings can result in several responses, the most stringent of which can immediately halt or restrict clinical trials in progress or, in extreme cases, disqualify a scientist from clinical research altogether. But according to the probe, which included a review of nearly 1,600 FDA inspection and enforcement documents for clinical trials, the agency rarely levels sanctions. When it does, follow-ups are either slow or neglected, and cases are frequently resolved based on unverified claims by those accused. What’s more, the analysis reveals that the agency’s approach to enforcement appears to be getting worse. While the agency issued 99 and 36 warning letters for serious clinical trial transgressions during the first and last three years of the Obama administration, respectively, only 12 were issued during the first three years under President Donald Trump. Disqualifications of “egregious offenders” also plummeted under Trump. The findings provide a “cautionary take” as the FDA oversees numerous fast-moving trials of vaccines and drugs for Covid-19, writes the author.
“A Science investigation shows that FDA oversight of clinical trials is lax, slow-moving, and secretive — and that enforcement is declining. (The investigation) included a review of some 1,600 agency inspection and enforcement documents for trials that the FDA said violated rules and law. Almost all were acquired via FOIA (the Freedom of Information Act) requests, including many made by FDAzilla, a commercial service that tracks the agency,” says the report.
Patricia Zettler, a lawyer who reviewed Science’s findings, writes, “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,” says. She worked for FDA from 2009 to 2012, rising to associate chief counsel.
The findings
The period examined covered former President Barack Obama’s administration and the first three years of Trump’s term. “Clear corrections of inspector-reported dangerous or unlawful clinical trial practices were the exception, even amid signs that trial participants were harmed and that data underpinning evidence-based medicine were corrupted. On the rare occasions when FDA formally warned researchers of findings that they had broken the law, the agency often neglected to ensure that fixes occurred,” the report states.
FDA inspections can result in a range of responses, from “no action” declarations, to “official action indicated” (OAI) reports that require a violator to clean up serious transgressions; to warning letters, which threaten further regulatory action unless corrections are made promptly. In extreme cases, the agency can even disqualify a scientist from clinical research. The probe, however, found that the agency almost always rules that no action is warranted or requests voluntary corrections, according to documentation on all inspections that drew an OAI designation or more severe enforcement action. Since 2009, FDA has used the OAI designation to direct only 291 of the inspected researchers or institutions — about 4% — to correct serious, illegal, and potentially dangerous clinical trial problems. “Furthermore, FDA officials sometimes downgraded a problem originally classified by inspectors as OAI — in which compliance must be confirmed by a follow-up inspection or other actions — to ‘voluntary action,’” it suggests.
The report also says that under Trump, the number of FDA inspections per year has increased significantly, yet enforcement actions have nosedived. About 6% of FDA inspections were classified as OAI during the Obama administration, but 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 3 years,” it explains. FDA did not dispute Science’s figures 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 wrote in an email.
For extreme problems in a clinical trial, when patients or data reliability are at immediate and serious risk, FDA can use warning letters to immediately halt the trial or restrict an institutional review board (IRB) from approving new trials. The agency did so seven times during Obama’s first term and not once since Trump took office.
Among the 291 OAI cases, only 71 resulted in a clear regulatory endpoint — such as disqualification, a “closeout letter” certifying that corrections were completed, or another formal statement. For the remaining 220, no clear outcomes could be found in public documents or data banks, leaving trial participants and others in the dark. Additional documents released by FDA under FOIA requests describe how 16 cases were resolved: most were based on written promises from researchers. In one, the researcher pledged to never again conduct clinical studies and then violated that pledge, “according to records posted by drug companies that hired him for clinical trials, with no apparent FDA response.” In an email, the FDA defended its approach, noting its “strategy to focus inspectional resources on higher-risk facilities.” The agency added that it tries to address clinical trial problems early on, so “an issue that might warrant a warning letter could be resolved before the problem rises to that level.”
Disgraced researchers can still reap drug industry payouts
When the FDA disqualifies clinical researchers who it determines have violated the law, falsified data, or committed grave errors or misconduct, they can no longer run human trials in the US. But that does not always “sever their financially rewarding relationships with big pharma,” claims the study.
In 2008, for example, FDA filed a public notice that it had disqualified Texas urologist James Vestal after its inspectors discovered “egregious problems in clinical trials” he had led of an experimental hormonal treatment for advanced prostate cancer. The agency said Vestal admitted to fabricating medical exams, faking signatures, enrolling ineligible patients, and other actions that “exposed (his) subjects to unnecessary risks.” “Yet a Science examination of corporate compensation disclosures from the federal Open Payments database showed that from 2013 to 2019, 27 drugmakers, including heavyweights Bayer, the Johnson & Johnson subsidiary Janssen, and Sanofi, paid Vestal about $422,000, including $340,000 for consulting and teaching. The system only began to record pharmaceutical compensation to physicians in 2013. Vestal did not respond to requests for comment,” explains the investigator.
In 2005, FDA disqualified Philadelphia dermatologist Harold Farber just before he pleaded guilty to two federal crimes. He was sentenced to probation and medical supervision of his practice and paid about $220,000 in fines and restitution. The analysis suggests that since then, Farber has “recouped those losses in other ways, thanks to the pharmaceutical industry.” From 2013 to 2019 alone, Open Payments data show, he took in about $665,000 from 45 medical research companies — including Actavis, Allergan, Bayer, and Genentech — for consulting and teaching. “Pfizer paid him the most, $90,000. He received $169,000 in other fees, food, and travel perks. Asked whether he informed the companies about his FDA disqualification and legal history, Farber declined to comment,” it adds.
In response to Science’s question to 33 drug companies as to why they paid Vestal or Farber to teach or consult after FDA expelled them as clinical investigators, 22 replied. They said the two remain qualified physicians who were not hired for clinical trials. None mentioned whether they knew about the FDA sanctions, or Farber’s criminal conviction when they made the payments. Among the 42 other physicians FDA has disqualified since 2005, data from 2013 to 2019 show five others took in about $10,000 to $36,000 in drug company payments after their bans.