Now that the dust is still swirling over the news that Scott Gottlieb will leave the FDA, it’s time to conduct a hasty post-mortem on his tenure at the agency, or perhaps more to the point, his lack of tenure. While it’s tempting to frame the question that way, it might be more salient to ask about the nature of the FDA commissioner’s job and whether it is still sufficiently politically insulated to do what is asked of it.
Gottlieb had been on the job roughly 22 months when he advised the Trump administration of his resignation, but making his home in Westport, Ct., and his work in Washington, D.C. might have made this “temp” employment from the outset. We may never know the circumstances under which Gottlieb took the job. True, he had worked at the American Enterprise Institute for a time before that, but an AEI gig seems more amenable to a telecommute than an FDA post. It could be that Gottlieb advised the administration he would take the role on the proviso that when he’d had enough, he’d had enough.
Certainly, President Trump has had nothing but praise to lavish on Gottlieb, and we all know Trump well enough to know he’d complain if he felt he had cause. But at bottom, it could be that Gottlieb only took the job in the first place because, as the saying goes, if the President asks you to take something on, you take it on if you’re a civic-minded sort, which Gottlieb clearly is. His explanation that he wants to spend more time with his family might indeed be legit, even if it sounds like the rhetorical aftermath of a corporate defenestration. All the available evidence tells us Gottlieb left at his own urging and/or that of his young family.
The commissioner is dead, long live…
The problem for we FDA watchers, however, is that there seems to be a trend of rapid churn at the commissioner’s chair. True, Robert Califf took the appointment toward the end of a president’s second term, which is the kiss of death for any real staying power, but that interpretation speaks once again to the sense of what might be loosely described as noblesse oblige that goes with the territory. Many of us thought that anyone who believed Califf would be there for an extended period of time was horribly naïve, a position events ably bore out.
Prior to Califf was Peggy Hamburg, who held the job for nearly six years, but Hamburg is the exception. She was preceded by Andrew von Eschenbach, whose run lasted a mere 25 months, and while we can throw out Lester Crawford for being a highly conspicuous outlier, Mark McClellan was there for less than a year and a half. If, in a fit of statistical propriety, you also chuck the term of Hamburg as the other outlier, the average tenure of recent FDA commissioners is a lot less than two years. I think most of us would agree that this is well short of ideal.
So that leads us to ask: How do likely candidates see the job of FDA commissioner? Corollary to that is whether that perception is a disincentive. Granted that some people don’t mind uprooting their family, but this isn’t the 1960s, when IBM came to mean I’ve Been Moved, as Gottlieb’s announcement made clear. We might also recall the rather brutish treatment von Eschenbach received during his confirmation hearings, but it’s pretty clear, even without considering that episode, the job is now so politically charged that its responsibilities are themselves disincentives.
Short-timers in vogue at HHS
One thing we ought not want to see is a revolving door at the FDA commissioner’s post, which is what happened to the CMS administrator’s job for a period of time. After the aforementioned Mark McClellan left the CMS in 2006, four years would elapse before the acting administrator title would fall to something less ephemeral. Donald Berwick took the title in 2010, only to be ousted by the end of 2011. His replacement, Marilyn Tavenner, was not appointed until nearly another year and a half had passed, and the pattern hasn’t exactly been broken since then, as Andy Slavitt will testify. Much of this has been blamed on how political the job is, but that leads us right back to the FDA commissioner problem.
As a med tech writer, I’m not particularly concerned about the day-to-day operations at the FDA’s device center, principally because Jeff Shuren knows his way around the federal government. Shuren has directed the Center for Devices and Radiological Health for nearly a decade now, and his counterparts at the Centers for Drugs and Biologics are no rookies, either. In fact, the argument could be made that the commissioner’s office can do little to alter the course of events at the centers, even if the “commish” can push new imperatives into play. After all, the digital push at CDRH didn’t magically appear when Gottlieb showed up, even if he did enable it with gusto. But as has already been suggested of Gottlieb’s time, the commissioner’s responsibility is at least as much about showing up at public forums and keeping in touch with key players in the House and Senate as it is about running the show at the FDA.
But what I am concerned about is the prospect that the FDA commissioner’s office will become hostage to the ongoing civil war between Democrats and Republicans on Capitol Hill. That is pretty much what happened at to the CMS position, and while I recognize that CMS is no longer “just a check-writing agency,” as the saying goes, it’s not as if life-saving drugs and devices will go unapproved if things there are bollixed up. That’s a real threat if things at the FDA go sideways, however. We might also consider the fate of issues such as the commercial speech problem and legislation for lab-developed tests, both at risk in an environment in which no one wants anything to do with the FDA.
History may ultimately prove that the Califf-Gottlieb stretch is a fluke, in which case the point of this entire essay is nowhere to be found. Still, we who spend our professional lives watching the FDA find ourselves wondering who would want the job, particularly given the insane demands on one’s time. We might be forgiven for thinking that even if the title comes with a solid paycheck, it’s not even close to being “substantially equivalent” to a similarly remunerative position in the private sector, where the klieg lights aren’t quite so bright, and the demands aren’t so outlandish that we are all now asking ourselves, “how long will the next commissioner last?”