FDA’s new man of regulatory mystery

Life has a lot of unknowns, and one of the big unknowns for 2019 is what the FDA will look like now that Scott Gottlieb has returned to the American Enterprise Institute. Norm Sharpless of the National Cancer Institute has been named the acting FDA commissioner – which by itself doesn’t mean a whole lot, other than that he has to be considered a lead candidate for the job – but the difficulty in knowing where the agency would go in terms of policy under the 52-year old Sharpless is that he isn’t exactly a known quantity where FDA policy is concerned.

Gottlieb’s views on matters such as the commercial speech question were well known before he joined the FDA in 2017, but Sharpless’ work history is mostly about clinical and pre-clinical research. Ergo, he’s something of a black box when it comes to policy questions such as commercial speech and regulation of lab-developed tests. True, many of these policies are operating under some greater or lesser degree of momentum of their own, but the idea that a new commissioner can’t boost or impede the advances of such policies is a bit difficult to comprehend. After all, even benign neglect isn’t exactly harmless where these and other issues are concerned.

Extensive private sector experience says …

On the other hand, Sharpless is an appointee for a Republican administration, and is one of the founders of a private company called G1 Therapeutics, not the first company he has founded. He also has been one of the authors of a dozen patent applications, so he undoubtedly has some appreciation of the vagaries of intellectual property in American commerce. That has to say something about his views of the agency’s proper role in regulation of drugs, devices and biologics, even if he isn’t terribly familiar with Title 21, §820. Or does it?

The line in Vegas would probably have Sharpless as a shoo-in for the commissioner’s job, assuming gamblers are inclined to drop money on such things, but it’s doubtful whether the oddsmakers are offering a line on much of anything else if Sharpless gets the job. Like it or not, we’ll all just have to wait and see. Granted he is unlikely to exercise the kind of aggressiveness that David Kessler did, but Kessler was appointed by a Republican president and promptly rolled out the warning letter program. So much for a light regulatory touch by a GOP appointee.

The point here is that we don’t have to cite situations like David Souter’s time on the bench at the Supreme Court to know there are a lot of surprises when it comes to government administrators and others in public life. There are probably a fair number of people who were taken aback on how aggressively Gottlieb went after both tobacco and non-tobacco, nicotine-containing products, after all. Public health advocates surely lauded some of these developments, but now there’s a push against smokeless tobacco despite that many had argued that these products might be key to un-hooking cigarette smokers and gradually steering them away from nicotine permanently.

Obviously predictability is in short supply these days, as always, but if we can hope for anything on the point of predictability, it might be that Sharpless hangs around a little longer than Gottlieb. Say what you will about the longevity of center directors, this kind of churn at the commissioner’s chair is well short of ideal.