Expect major changes in the way the FDA does business with drug companies after the Trump administration takes over in January.

The anti-establishment theme of Trump’s victory bodes ill for such establishment-favored FDA conventions as curbing off-label promotion, blocking internet trafficking of prescription drugs from foreign pharmacies, and holding drug and medical device manufacturers to research and production manufacturing standards deemed “esoteric.”

As in past political transitions, expect the shakeup to begin with new political intrusions into the status quo, starting with FDA commissioner Robert Califf, who is expected to submit his resignation.

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Only once has a commissioner survived this process. That was Republican appointee David Kessler when the Clinton administration took over from President George H.W. Bush’s administration back in the early 1990s.

Since then, the FDA has become an increasingly politicized federal agency, especially during the second Bush administration.

One measure of this has been the agency’s increased hiring of key personnel direct from regulated industry, a practice historically verboten but embraced by Republican administrations.

Conflict-of-interest concerns, fanned by activist organizations like Public Citizen, remain an issue, but this expertise-hungry agency has been inventive in finding ways around them.

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Trump’s history in business management provides few clues to such practicalities, but his campaign for the White House demonstrated an acute sensitivity to apparent conflicts of interest in Hillary Clinton’s history.

There is also the issue of the FDA’s traditional independence from politics in the approval of new products.

That was a big issue in the second Bush administration when it vainly fought to not allow the FDA to approve Plan B, the over-the-counter morning-after contraceptive, for teens of a certain age.

It wouldn’t surprise me to see similar tussles under President Trump.


James Dickinson is editor of Dickinson’s FDA Webview.

From the December 01, 2016 Issue of MM+M - Medical Marketing and Media