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Enforcement Down

Enforcement actions by the US Food and Drug Administration have fallen since President Donald Trump took office, according to an analysis by Science.

Between President Trump's inauguration and May 22, FDA issued 1,033 warning letters, while an equivalent time period during the Obama Administration saw 1,532 such letters sent, Science found. Additionally, it notes that the FDA Center for Devices and Radiological Health has sent much fewer warnings than previously, with some of its offices not issuing any warnings in more than two years.

"Those who think the Trump administration has not succeeded in its deregulatory efforts ought to look at these data," Peter Lurie, a former FDA official, tells Science. "Industry may well take the message from this that the cop is not on the beat as often."

This appears to be a continuation of a trend noted by Bloomberg in 2017. It reported then that during the first seven months of Trump Administration, FDA sent 265 warning letters, an 8 percent drop as compared to the first seven months of the Obama Administration.

FDA tells Science that it has a number of enforcement tools at its disposal, including ones that are not as publicly visible as warning letters, that it uses.

"We were pretty aggressive," former FDA Commissioner Scott Gottlieb tells Science. "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."

Still, some agency watchers say they are concerned that this decline in enforcement action suggests violations will be tolerated.