Enforcement at the FDA reportedly slumped after President Donald Trump took office, with warning letters off by a third and medical device warnings off by two-thirds.
From the January 2017 inauguration through May 22, the FDA issued 1,033 warning letters, a -32.6% decline compared with the most recent equivalent from the Obama administration, Science magazine reported.
And the federal safety watchdog’s Center for Devices & Radiological Health and district offices in Philadelphia, Florida, and New York are down by more than two-thirds – two district offices haven’t put out a warning in more than two years, according to the magazine. And the FDA sent significantly fewer warning letters in the second year of the Trump administration than in the first.
“Those who think the Trump administration has not succeeded in its deregulatory efforts ought to look at these data,” former FDA executive Peter Lurie, now executive director of the Center for Science in the Public Interest, told Science. “Industry may well take the message from this that the cop is not on the beat as often.”
“FDA’s power to enforce its requirements is an important part of how it achieves its public health mission,” added Ohio State University law professor Patricia Zettler, a former FDA attorney. “If FDA is not using that power, it sends a signal that violations will be tolerated.”
Former FDA commissioner Dr. Scott Gottlieb said the agency was “pretty aggressive” in enforcing its regulations.
“We were pretty aggressive,” Gottlieb told the magazine via 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.”
The FDA improved enforcement efficiency and expanded field resources during his tenure there, he added in an interview, with stem cells, vaping, dietary supplements, homeopathy, opioids, and generic drugs coming under focus. Warning letters and other such actions are imperfect enforcement measures, Gottlieb argued, according to the report.
“Sometimes the actions we take are visible, like warning letters (or) recalls,” the FDA said in a prepared statement sent to Science. “At other times, our actions to protect consumers are less discernible, but equally vital.”
“The FDA’s enforcement role is extremely important,” former acting commissioner Joshua Sharfstein told the magazine. “If the FDA isn’t doing enforcement, nobody’s doing enforcement.”
