Number of ‘warning letters’ sent by FDA has fallen by 33% compared with the most recent equivalent period under Obama

This article is more than 1 year old

This article is more than 1 year old

The US regulator of food and drug safety has seen steep declines in several markers of enforcement under the Trump administration, according to a new analysis in the journal Science.

The Food and Drug Administration (FDA) sends “warning letters” for tainted food, improperly advertised dietary supplements or even violations of human subjects’ protections in clinical trials.

The number of letters issued has fallen by 33% under Donald Trump, compared with the most recent equivalent period under the Obama administration. They fell from 1,532 under Obama to 1,033 under Trump, according to the analysis published by the American Association for the Advancement of Science.

“They’re a very serious and central part of how the FDA manages compliance and enforcement … it basically is an expectation that corrections will be made and made rapidly,” said the investigation’s author, Charles Piller.

The number of warning letters also fell significantly between Trump’s first and second years.

In one example Piller noted, the FDA failed to issue a warning letter for clinical trials of experimental drugs, including the anaesthetic ketamine, after questions were raised about alleged lapses in informed consent and coercion of patients. The trials also failed to report that some patients developed breathing problems and moving disorders.

The decline in warning letters spans most FDA divisions, Piller said. One significant exception is the Center for Drug Evaluation and Research, which has issued more warning letters than under Obama, many of them for opioid sales or generic drugs made in China and India.

The FDA argues that it has other ways of enforcing food and drug safety, but experts interviewed by Piller were alarmed at the rate of decline in the warning letters and other measures.

Opioid crisis: FDA's own staff demand agency halt approval of new painkillers Read more

The analysis found that “Official Action Indicated reports”, which come before the letters, dropped 45%, from 1,879 to 1040. Injunctions to halt the concerning findings – which require FDA collaboration with the justice department – fell from 35 to 26.

The FDA in an emailed statement said the way the data is presented “does not accurately reflect FDA’s overarching work to protect the public health”, including because warning letters are just one part of how the agency gets regulated entities to comply.

“Our use of any one enforcement tool may fluctuate year to year based on a number of factors, including the FDA’s assessment of the violations uncovered during the course of inspections, along with additional product monitoring efforts,” an agency spokeswoman, Angela Stark, said.

She said warning letters have increased from some centers of the agency, and decreased in others, “because the FDA has increased its interactions with industry to resolve issues, which often achieves more timely and effective corrective action to inspectional findings.”

Stark added that the analysis of tobacco data didn’t count tens of thousands of warning letters and fines, including for retailers who illegally sold Juul and other e-cigarette products to minors.



The trend is not exclusive to the FDA.

Enforcement of environmental and health protections at the Environmental Protection Agency (EPA) has similarly declined, according to a report from the advocacy group the Environmental Integrity Project. The group found the EPA is conducting 60% fewer inspections of violations than the annual average and is referring fewer polluters to the justice department for civil prosecution.