FDA Enforcement Under Trump: CDER Actions Up, but Overall Warnings Down

July 17, 2019
Pharmaceutical Technology Editors

A July article in Science suggests that FDA enforcement activities have dropped significantly during the current US presidential administration.

A July study published in https://science.sciencemag.org/content/sci/365/6448/12.full.pdf" target="_blank">Science found that overall FDA compliance and enforcement activities have dropped dramatically during Donald Trump’s presidency. Between January 2016 and May 22, 2019, analysis of publicly available information found that the Agency issued nearly half the number of warning letters that it had issued over the same period during the Obama administration.

However, during the same period, FDA’s Center for Drug Evaluation and Research (CDER) increased enforcement activities, issuing 188 warnings compared with 116 under the previous administration. CDER’s oversight of clinical trials appeared to have become less stringent, though, with the Agency issuing seven warning letters related to clinical trial practices, compared with 17 during the same period under former President Obama.

Medical devices enforcement activities dropped most precipitously, Science’s research found, and the number of Warning Letters issued to device manufacturers fell by more than 66%. In addition, two district FDA offices overseeing devices had not issued any warnings in more than two years.

These results jibe with previous analysis of FDA enforcement efforts during the first year of President Trump’s administration. In a report published in 2018, analysts at PriceWaterhouse Cooper’s (PwC) Health Research Institute found that in 2017, the number of significant FDA regulatory actions was at its lowest level in 20 years. The Agency had issued six significant regulatory actions in 2017, the analysts found, compared with 30 in 2018, although none were related to pharmaceuticals or biotechnology.

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The Science article also suggested that injunctions requiring the cooperation of the US Department of Justice have become more challenging to pursue during the current administration, citing two unnamed sources who said that DOJ had blocked “numerous strong injunction requests from FDA” during this period, and one unnamed source, who noted that “it became much harder to bring new injunction cases after Trump took office.”