Scott Gottlieb leaving FDA: possible reasons, impact on stem cell field, & more

Dr. Scott GottliebMaybe the announcement that Commissioner Scott Gottlieb will be leaving the FDA soon shouldn’t have caught us all off-guard, but it did.

Gottlieb isn’t a perfect Commissioner, but he brought a sensible, open approach to running the FDA that was very refreshing. Amongst all the top leadership in the Trump administration, Scott Gottlieb stood out as being particularly supportive of his agency and its core mission. If anything he was the anti-politician in the room.

Is that what did him in? It’d be helpful to know the “why” behind the departure.

Why is the reason he left important? For a number of reasons, but most importantly because it is likely a clue as to the type of person who will be nominated to replace him.

He struck a logical balance in promoting innovation and protecting patients. This balance was very evident in the stem cell arena. Here, Gottlieb pushed forward innovation with the Regenerative Medicine Advanced Therapy (RMAT) designation program, and from a historical perspective he was active in an unprecedented way against predatory stem cell clinics. I’m very glad he mentioned the steps against these clinics in his resignation letter.

I hope that the FDA’s momentum on stem cell clinics won’t evaporate after his departure, but I’m worried on this front. A lot will depend on who is the next leader.

While the FDA was already working toward stepped-up action on “bad actor” clinics, as Scott Gottlieb called them in his very direct manner, even before his arrival at the agency, my sense is that he personally made a major difference in how aggressively the agency moved forward. The FDA under past Commissioners failed on the stem cell clinic issue, and it’s still a mystery why. Too timid? Too political?

fdafatstemcell_smI don’t know if he was aware (probably not), but one of my cartoons here on The Niche actually featured him (see at left), with the idea being that he had a huge battle on his hands facing the ubiquitous fat stem cell clinics from coast to coast.

The now-departing Commissioner also took positive actions on many other, arguably more acutely dangerous fronts including e-cigarettes and opioids.

Again, I hope we’ll learn the reason behind his departure soon, but I’d imagine it won’t be good news. There’s a good chance it was his anti-vaping stance, trying to get fewer kids hooked on e-cigs.

From the NYT:

“But he has also been subject to increasing pressure from Republicans in Congress and his former associates in the conservative movement for his tough stance against youth vaping and traditional cigarettes.”

On the other hand, maybe the reason he’s leaving is a personal one like he got sick of the politics or there’s something else going on.

Either way, his replacement is likely to have a tough time and will always be compared to Gottlieb. As the saying goes, I’m expecting the worst, but hoping for the best.

Anyway, thanks to Gottlieb for being a strong Commissioner and being so transparent about his goals and perspectives on really important issues. We haven’t seen that before at the top of the FDA.

3 thoughts on “Scott Gottlieb leaving FDA: possible reasons, impact on stem cell field, & more”

  1. I am sorry to see him go. I am a victim of one of these stem cell predators. I was really looking forward to him clamping down on on these criminals so there would be less victims….

  2. He lives in Connecticut and was commuting to Washington DC every week. I’m sure that makes one wonder if it is all “worth it”. His was a very tough job, especially given that so many like to say negative things about the FDA and to cast them all as being the “Bad Guys”. He stated openly he wanted to spend more time with his family (which I believe includes 3 kids), and this is a noble and understandable explanation. I don’t think his decision requires any more explanation than that.

    1. Michael,
      You make a good point and family is a big deal, but usually a relatively young, ambitious person who by all accounts is a big success in a powerful job wouldn’t just give it up. There was also no announcement about him moving on to some other fantastic position that could have motivated the resignation. Paul

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