FDA enforcement actions have ‘plummeted’ under Trump administration, says Science


CDER activity is one of the few exceptions

According to July 2 article in Science magazine, the overall volume of FDA warning letters, injunctions and “official actions” has dropped by 40%, when comparing the 28 months of the Trump administration (through May 22) with an equivalent period at the end of the Obama administration. Looking at warning letters specifically, the Science analysis finds 1,532 instances during the Obama period, but only 1,033 during Trump. The standout exception is the Center for Drug Evaluation and Research (CDER), whose warning letters rose to 188, versus 116 during Obama. Devices and Radiological health (CDRH) declined by 71%; Food Safety and Applied Nutrition declined by 37%, and Tobacco Products by 33%. The latter is especially surprising given the former Adminstrator Scott Gottlieb’s emphasis on e-cigarettes and limiting tobacco use by the young.

Longer-term data shows that overall FDA enforcement activity has been on the decline since 2012, but dropped precipitously after Trump took office. Science got comments from both FDA and Gottlieb; the latter saying that “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;” while the former saying that currently, there are “behind the scenes” compliance activities occurring.

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