FDA sharpen focus on pharmaceutical companies under Trump

The overall number of warning letters being sent out by the FDA has dropped under President Donald Trump, according to analysis posted in Science. However the number of warnings sent to pharma firms has increased.

According to research published in Science, the total number of warning letters sent out by the FDA has dropped by a third under President Donald Trump, with 1033 letters sent out since Trump’s inauguration, compared to 1532 under Barack Obama over the same period of time.

However, while the number of letters sent to medical device companies, food firms, and tobacco companies fell, the number of letters sent to pharmaceutical companies actually increased, with 188 warnings issued under Trump compared to 116 under Obama.

Opioid drugmakers and Chinese and Indian firms have been under particular scrutiny from the FDA's Center for Drug Evaluation and Research (CDER) under President Donald Trump.

Meanwhile the number of warning letters on clinical investigations fell under Trump as the CDER sent out seven letters on improper conduct in clinical investigations and protection of human subjects, compared to 19 warnings under Obama.

“Those who think the Trump administration has not succeeded in its deregulatory efforts ought to look at these data,” says former FDA exec Peter Lurie.

Former FDA commissioner Scott Gottlieb responded in an email: “We were pretty aggressive. 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.”  

Louis Goss