Drop in FDA Enforcement Noted
A Science exclusive investigative report says that by several measures, FDA compliance and enforcement actions have “plummeted” under the Trump administration. The agency’s Warning Letters have fallen by one-third, the report says, with FDA records showing 1,033 Warning Letters issued from President Trump’s inauguration through 5/22, compared with 1,532 for the most recent equivalent period under President Obama. “Compared with the start of the Obama presidency, Trump-era letters dropped by nearly half,” it says.
Warnings from CDRH have dropped by more than two-thirds, Science says, and two district offices have not issued a Warning in more than two years.
“The numbers don’t just reflect a new administration’s slow start,” the report says. “FDA sent significantly fewer Warning Letters in the second year of Trump’s presidency than in his first.”
Former FDAer Peter Lurie, now executive director of the Center for Science in the Public Interest, is quoted as saying that “those who think the Trump administration has not succeeded in deregulatory efforts ought to look at these data. Industry may well take the message that the cop is not on the beat as often.”
Science says the agency did not dispute the enforcement and compliance data it compiled from FDA public records. In a written statement to the journal, FDA said, “Sometimes the actions we take are visible, like Warning Letters or recalls…. At other times, our actions to protect consumers are less discernible, but equally vital.” Sometimes, FDA said, Warning Letters are not needed as a result of meetings with companies, follow-up inspections, the threat of mandatory recalls, a new voluntary improvement pilot program for device makers, coordination with European regulators, and unspecified “regulatory and compliance measures” conducted “behind the scenes.”
The journal contacted former commissioner Scott Gottlieb who said, “We were pretty aggressive. I don’t think you can paint us with a political narrative, that just because we were a Republican administration, somehow we must have ratcheted down enforcement activity. We didn’t.”
The report says CDER is the exception to the downward trend on Warning Letters, having issued 188 under Trump and 116 in the most recent period under Obama. It says many of the Trump-period letters concern opioid sales or over-the-counter and generic drugs made in China and India, which have rapidly gained market share despite quality lapses documented by FDA and others.