Stephan Schmitz/folioart
By Charles Piller
From monitoring clinical trials and approving medicines and vaccines, to ensuring the safety of blood transfusions, medical devices, groceries, and more, the U.S. Food and Drug Administration (FDA) is one of the nation’s most vital watchdogs. By several measures, however, FDA’s compliance and enforcement actions have plummeted since President Donald Trump took office, Science has found.
The agency’s “warning letters”—a key tool for keeping dangerous or ineffective drugs and devices and tainted foods off the market—have fallen by one-third, for example. Such letters typically demand swift corrections to protect public health and safety. FDA records from Trump’s inauguration through 22 May show the agency issued 1033 warning letters, compared with 1532 for the most recent equivalent period under former President Barack Obama. Compared with the start of the Obama presidency, Trump-era letters dropped by nearly half.
Warnings from the FDA Center for Devices and Radiological Health, which helps ensure the safety and quality of medical devices, and from some of the agency’s district offices—including Philadelphia, Florida, and New York—have dropped even more steeply, by more than two-thirds. Two district offices have not issued a warning in more than 2 years. The numbers don’t just reflect a new administration’s slow start. FDA sent significantly fewer warning letters in the second year of Trump’s presidency than in his first.
FDA watchers say they can’t pinpoint what’s driving the decline, but they are alarmed. “Those who think the Trump administration has not succeeded in its deregulatory efforts ought to look at these data,” says Peter Lurie, an FDA executive under Obama and Trump and now executive director of the Center for Science in the Public Interest, a Washington, D.C., advocacy group. “Industry may well take the message from this that the cop is not on the beat as often.”
Several other FDA actions under Trump show similar declines when measured against the end of the Obama administration. FDA inspection reports labeled “official action indicated”—typically a trigger for warning letters or similar actions—have fallen by about half under Trump and are continuing to trend downward. Even FDA’s rare injunctions, a more forceful step than warnings to prevent sales or distribution of unsafe or otherwise illegal products, fell from 35 in the last part of the Obama administration to 26 under Trump. (During a comparable period at the start of the Obama years, FDA issued 51 injunctions.) The agency’s “untitled letters”—for concerns that fall short of thresholds for formal warnings—also have dropped sharply under Trump.
Watchdog off duty?
Graphic: N. Desai/Science; Data: FDA
“FDA’s power to enforce its requirements is an important part of how it achieves its public health mission,” says Patricia Zettler, a law professor at Ohio State University in Columbus and former FDA attorney. “If FDA is not using that power, it sends a signal that violations will be tolerated.”
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.”
Scott Gottlieb, Trump’s first FDA commissioner, defended his record after reviewing a summary of Science’s data. “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.”
Centers of inaction
Graphic: N. Desai/Science; Data: FDA
Gottlieb, a physician and venture capitalist before being tagged for FDA, resigned in March and is now at the American Enterprise Institute, a conservative think tank in Washington, D.C. On his watch, Gottlieb said later in an interview, FDA 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. He argues that warning letters and other such actions are imperfect enforcement measures.
The only significant exception to the downward trend on warning letters is 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. 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.
Besides regulating consumer products, FDA protects subjects in clinical trials by reviewing informed consent and other ethical practices. In the most recent period under Obama, CDER issued 19 warnings concerning improper conduct of clinical investigations and protection of human subjects; under Trump the number fell to seven.
Michael Carome, who directs health research at the Washington, D.C., consumer advocate Public Citizen, points to clinical trials at Hennepin County Medical Center in Minneapolis, Minnesota, as an example of FDA’s sluggish approach to human subjects protections. In July 2018, Public Citizen and more than 60 clinical scholars and ethicists complained to FDA about apparent lapses in informed consent and possible coercion of unwitting and vulnerable patients treated with powerful experimental drugs, including ketamine. The anesthetic and pain reliever was being tested to control agitation.
The next month, an FDA inspection of the trials validated some of Public Citizen’s concerns. After a second inspection, FDA cited other serious transgressions. As first reported by Minneapolis’s Star Tribune, these included failing to report to an oversight body that some patients developed serious breathing problems and movement disorders.
A tale of two presidents
Graphic: N. Desai/Science; Data: FDA
In May, the medical center’s operator disputed most FDA findings, but agreed to make a few procedural changes. Nearly a year after the original complaint, FDA has yet to issue a warning letter. The agency declined to comment about the case. “It was among the more serious things I’ve seen in human subjects protection violations,” says Carome, previously a Department of Health and Human Services official tasked with protecting human subjects. “Maybe [the FDA is] not taking appropriate action in some of these cases.”
Even electronic cigarette enforcement has seen mixed results under Trump, despite Gottlieb’s public stand against teen vaping. On the one hand, a special program to police retail sellers of tobacco and vaping products—such as convenience and grocery stores—issued about as many warnings and fines under Trump as at the end of the Obama years. Gottlieb says FDA put managers of large retail chains on notice to improve compliance. He also implemented a rule finalized under Obama that gave the e-cigarette industry a road map to comply with federal tobacco laws.
But warnings from the FDA Center for Tobacco Products, whose targets include wholesalers, online vendors, makers and suppliers of vaping liquids, and importers, dropped by one-third. Gottlieb’s FDA also delayed from 2018 to 2022 an Obama-era deadline requiring e-cigarette–makers to submit products for premarketing review, reasoning that this would give the industry time to develop in ways that help adult smokers quit. (FDA recently advanced the deadline to 2021.)
Federal data show vaping among high school students shot up 78% from 2017 to 2018, and 48% among middle school students. Last year, FDA said it would restrict some sweet vaping flavors that entice children and began to enforce nicotine warnings on such products and crack down on improper marketing. But given the teen vaping epidemic, some critics view such moves as too little, too late. “Had we known there was going to be an epidemic of youth use … we would have made different decisions” and moved more quickly, Gottlieb concedes. He says that delaying the review deadline helped to ensure adequate guidance for industry, and was not responsible for the youth crisis.
Those who think the Trump administration has not succeeded in its deregulatory efforts ought to look at these data.
Deregulatory pressure from the White House has had profound effects on several federal agencies, but whether and how it might explain the drop in some elements of FDA enforcement is unclear. The agency 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) 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.
In its statement to Science, FDA did not address the allegations, but called DOJ a “strong partner.” DOJ did not respond to queries.
Joshua Sharfstein, a health policy researcher at Johns Hopkins University in Baltimore, Maryland, who worked at FDA under Obama, including as its acting commissioner, says he hopes the data found by Science will prompt a closer look at the apparent declines in enforcement, and help clarify what has caused them. “The FDA’s enforcement role is extremely important,” he says. “If the FDA isn’t doing enforcement, nobody’s doing enforcement.”
Source: Science Mag