David Bowen
David Bowen

OK, I’ll admit it.  I’m a diehard liberal.  As such, I’m not predisposed to favor the appointments made by the Trump Administration.  I’m particularly sensitive to appointments made in the areas for which I once had responsibility. As health policy director for the Senate health committee, I was the lead staffer handling public health appointments, including FDA Commissioner.

My antennae perked up two years ago when I heard that the Trump Administration had nominated Scott Gottlieb to lead FDA. I know Scott, who had appeared as an expert witness before the committee in both formal hearing and informal briefings, and had even debated him on a panel after I left the Senate staff. I knew and respected his intellect and knowledge of the life sciences industry, but I was wary that he might adopt the reflexively anti-regulatory stance so prevalent in the Trump Administration.

I’m delighted to have been wrong. Under Commissioner Gottlieb, FDA has often adopted thoughtful policies on matters ranging from e-cigarettes to opioids to real world evidence. Just last week, I was discussing FDA over a beer with a fellow Senate ex-staffer (and yes, that really is what health policy wonks discuss over beer), and we agreed that FDA had been a pleasant surprise.  Little did we realize that Gottlieb was probably drafting his letter of resignation at that very moment.

Now what?  Once again, the Trump Administration will name the leader of an agency that oversees not only the medicines we rely on to protect us against illness, but also medical devices, cosmetics, consumer health products and much of the food we eat. In short, the nominee—who is almost certain to be confirmed by a Republican Senate—will have a hell of an impact on the health industry.

Unlike many departures from the Trump Administration, Gottlieb’s departure was not a death foretold.  There has been little speculation about successors waiting in the wings, as there currently is for agency heads rumored to be on the Trump chopping block, but there are probably three broad directions in which the Administration could go.

Continuity. Elevating a current senior staffer at FDA to Commissioner, or nominating a past Republican Commissioner, would represent a continuation of the direction that Gottlieb set.  For the life sciences industry, continuity might be the most desirable choice. Certainty is manageable, and reduces costs of compliance with new initiatives.

Deregulation. For many other regulatory agencies, such as EPA, the Trump Administration has launched a major effort to dismantle what it characterizes as burdensome regulations. While some in the life sciences industry may sympathize with this deregulatory impulse, the timing works against significant changes unless President Trump is re-elected. By the time a nominee is vetted, proposed and considered by the Senate, the new Commissioner will have little time to propose deregulatory changes and carry them through before the next general election.

Radical restructuring. Some Republicans have argued for fundamental restructuring of the way FDA operates, so that drugs would be allowed on the market with comparatively minimal regulation, to let markets decide which ones are safe and effective. The life sciences industry has invested millions of dollars in complying with the current regulatory structure and has amassed a considerable competitive advantage in knowing how to work the system, so industry might react with deep trepidation to a Commissioner who envisions major changes to current practice.

A glimpse into the crystal ball. Any conventional Administration facing subpoenas and investigations would not seek to add to its controversies by nominating a lightning rod for criticism to head the FDA.  Since the Trump Administration is far from conventional, it’s tempting to predict that they will do the opposite and name a firebrand. Even if they did have that desire, however, Majority Leader McConnell would probably want to avoid yet another nomination fight, especially if stakeholders in the pharmaceutical industry were leery of radical changes in FDA direction. At the risk of being proven dead wrong in public, I’d expect a nominee who will broadly continue the current direction of the agency. 

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David Bowen is global lead, health practice, at Hill+Knowlton Strategies and head of WPP Health's policy & PA group. Previously, he was health policy director for Senator Ted Kennedy, where he had a leading role in developing the Affordable Care Act before moving to the Bill & Melinda Gates Foundation to lead initiatives to create partnerships with governments to support polio elimination.