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July 2, 2019

Formal FDA enforcement action declines under Trump

Compliance and enforcement actions by the US Food and Drug Administration (FDA) have dramatically declined under the Trump administration, with medical devices seeing the steepest drop, according to a new report.

By Chloe Kent

Compliance and enforcement actions by the US Food and Drug Administration (FDA) have dramatically declined under the Trump administration, with medical devices seeing the steepest drop, according to a new report.

An investigation into the matter, led by American Association for the Advancement of Science (AAAS) Science contributing correspondent Charles Piller, found that FDA warning letters have decreased by a third since Donald Trump took office. Warnings from the FDA Center for Devices and Radiological Health, which helps ensure the efficacy of medical devices, have dropped even more dramatically by nearly two thirds.

Significantly fewer letters were issued during the second year of Trump’s presidency than the first. According to Piller, this indicates that the decline is not simply the result of a new administration finding its feet but symptomatic of a deeper issue. Compared with the start of the Obama presidency, Tump-era letters have dropped by nearly half.

Public FDA records from Trump’s inauguration through to May 2019 show that the FDA has issued 1,033 warning letters in this period, compared with 1,532 for the most recent equivalent period under the Obama administration.

Alongside the decrease in warning letters, FDA inspection reports labelled ‘official action indicated’, which typically trigger a warning letter or similar enforcement action, have fallen by 45%. Injunctions have also lessened, from 35 in the most recent equivalent period of the Obama administration to 26 under Trump. During the comparable period at the start of the Obama years, the FDA issued 51 injunctions.

While the cause of the overall decline in FDA enforcement actions is unclear, observers of the agency have found the trend alarming.

Former FDA executive and Center for Science in the Public Interest executive director Peter Lurie said: “Those who think the Trump administration has not succeeded in its deregulatory efforts ought to look at these data. Industry may well take the message from this that the cop is not on the beat as often.”

The only significant exception to the downward enforcement trends was in the FDA Center for Drug Evaluation and Research, which has issued 188 warnings under Trump, compared with 116 in the most recent period under Obama.

In a statement to Science the FDA accepted that the number of warning letters and associated regulatory actions had decreased, but maintained it was focusing on “less discernible, but equally vital” work.

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