FDA Enforcement of Clinical Trial Violations Declining Under Trump
The FDA has been slacking off on enforcement of clinical trial regulations, according to a recent investigation of the agency’s inspection statistics that shows a substantial drop in serious citations in the first three years of the Trump administration.
Since 2009, the FDA has conducted about 6,700 inspections of clinical investigators and IRBs, issuing the strongest citation, “Official Action Indicated” (OAI) in only 291 cases (4 percent) for serious, illegal and potentially dangerous clinical trial infractions.
But in the first three years of the Trump administration, that number dropped to 1 percent. In comparison, the eight years of the Obama presidency saw the agency issue OAI citations in about 6 percent of cases, an article in the October issue of Science magazine points out.
The article’s authors examined 1,600 FDA inspection and enforcement documents issued since 2009, including warning letters and investigator debarment notices, concluding the agency’s regulatory enforcement has become “lax, slow-moving and secretive.”
The number of warning letters issued to investigators and IRBs also dropped dramatically during the first three years of the Trump presidency. The FDA issued only 12 warning letters from 2017 to 2019, while President Obama’s FDA issued 99 from 2009 to 2011, the first three years of his first term, and 36 from 2014 to 2016, the last three years of his second term.
Warning letters in Obama’s first term resulted in seven trial and IRB shutdowns and restrictions, but the Trump administration has not followed through with enforcement action on any of its 12 cases.
Noncompliant investigators also got off light under Trump; only two were barred from participating in future FDA-regulated trials. The FDA barred an average of three investigators per year — mostly for data falsification — under President Obama.
The FDA did not dispute the figures in the Science article and said that Trump administration policies were not a factor. “The number of warning letters can ebb and flow,” the agency wrote in an email.
The reporting of the story was funded by Science’s Fund for Investigative Journalism.