Report: FDA Enforcement Actions Declining

An exclusive report by Charles Piller on July 2, 2019 in Science (“Exclusive: FDA enforcement actions plummet under Trump”), reveals that FDA enforcement actions began to decline under the Obama Administration and are plummeting under the Trump Administration.

For example, the agency’s warning letters have fallen by one-third over a comparable period from the previous administration.

FDA records, according to Piller, show that since Trump’s inauguration in January 2017 through May 22, 2019 show the agency issued 1,033 warning letters, compared with 1,532 for the equivalent period under the previous administration. Compared with the start of the Obama presidency, Trump letters dropped by nearly half.

“Warnings from the FDA’s Center for Devices and Radiological Health (CDRH)…have dropped even more steeply, by more than two-thirds. Two district offices have not issued a warning in more than two years.” And the pace of warnings is slowing. FDA sent significantly fewer warning letters in the second year of the current administration than in the first.

Missing Cop on the Beat?

Peter Lurie, a former FDA executive under both Obama and Trump told Piller, “Industry may well take the message from this that the cop is not on the beat as often.”

FDA inspection reports labeled “official action indicated” have also fallen by about half under Trump and are continuing to trend downward.

FDA injunctions for the comparable Obama period fell from 51 to 26.

To be fair, the number of warning letters began to drop off during the last few years of the Obama Administration. There were around 800 warning letters in both 2011 and 2012. By the time Trump took over, Warning Letters had steadily declined to just a little over 500. If that trend continues into 2019, the number of Warning Letters of the two Administrations would be very close.

FDA Responds

FDA did not dispute the enforcement and compliance data, which Science compiled from the agency’s own public records.

In a written statement, the agency responded, “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.….Among the efforts that can obviate the need for warning letters, FDA noted, are meetings with companies, follow-up inspections, the threat of mandatory recalls, a new voluntary improvement pilot program for devicemakers, coordination with European regulators, and unspecified “regulatory and compliance measures” conducted behind the scenes.”

After reviewing a summary of Science’s data, Scott Gottlieb, M.D., Trump’s first FDA commissioner, defended his record. “We were pretty aggressive,” he wrote in an email. “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.”

In a follow-up interview, Gottlieb said the agency made enforcement more efficient and expanded field resources. The agency’s budget rose 21% from fiscal years 2016 to 2019. He says that under Trump, FDA issued guidance or beefed-up enforcement on stem cells, vaping, dietary supplements, homeopathy, opioids, and generic drugs.

“FDA’s Center for Drug Evaluation and Research (CDER), which assesses and approves new drugs and polices existing drugs for safety and efficacy. It has issued 188 warnings under Trump, compared with 116 in the most recent period under Obama.”

Piller concluded that it was unclear if the drop in FDA enforcement is a result of deregulatory pressure from the White House.

He noted the agency [populated by scientists] has few political appointees and is relatively decentralized. “Some insiders say Gottlieb generally supported vigorous enforcement. But for some actions, including injunctions, FDA requires Department of Justice (DOJ) [populated by lawyers] cooperation. Two people with personal knowledge of FDA enforcement, who decline to be named for fear of reprisals, say that under Trump, DOJ has blocked numerous strong injunction requests from FDA. One source says it became much harder to bring new injunction cases after Trump took office.”