The fine art of treading a fine line

So, as many probably suspected, we now know that FDA Commissioner Scott Gottlieb will be heading back to work at the American Enterprise Institute when he steps down from his current position at 5:00 p.m. today.

In his 2+ years at the FDA, Dr. Gottlieb accomplished some remarkable — and some utterly unexpected — things.

Most notably, he succeeded in raising the FDA’s annual Congressional budget appropriation by  $41 million for FY 18 over FY 17 (see here); by $269 million for FY 19 over FY 18 (see here); and by setting the stage for an additional increase of about $360 million for FY 20 (see here). Working within an administration highly motivated to lower federal appropriations for government agencies, that — perhaps above all else — is a clear signal of Dr. Gottlieb’s persuasive abilities.

Should the FY 20 budget increase go through at around even $300 million, Dr Gottlieb will very reasonably be able to claim a large chunk of the credit for an astonishing 24% increase in the FDA’s budget from FY 17 ($2.8 billion) through FY 20 ($3.4 billion). While the Alliance for a Stronger FDA would certainly argue that the FDA is still relatively underfunded, given it’s national and international mandates, such an increase in the FDA’s budget over a 3-year period is unprecedented. On that basis alone, Dr. Gottlieb has certainly earned the right to a little time off for the stated trip to Disney World with his family.

Historically, most FDA Commissioners have kept a relatively low profile after leaving office, and — unsurprisingly — Dr. Gottlieb is well aware of the need to avoid “causing grief” to the incoming Acting Commissioner, Dr. Ned Sharpless. However, …

It is unlikely that Dr. Gottlieb is going to have quite such a low profile as some of his predecessors. Before he ever went to the FDA the first time, working under then-Commissioner McClellan, and before coming back to the FDA as Commissioner himself in 2017, Dr. Gottlieb has been a regular and opinionated commentator on a wide range of issues that impact the business of health care in America. He has already made it clear that he will continue to express opinions on these issues.

It will be interesting to observe as Dr. Gottlieb seeks to ensure that he can gain traction for a number of the business-related issues that most interest him while maintaining a clear distance from any suggestion that he is making life difficult for his successor (or successors) at the FDA.

We wish him luck.

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