FDA's Newest Head Honcho: Dr. Scott Gottlieb

Posted by Mitch Clarke on 15th Mar 2017

Now that Tom Price has been approved as the newest Secretary of Health and Human Services—winning himself a well-earned Senate confirmation just last month—vaping advocates and ANTZ alike watched wide-eyed as the Trump administration indecisively hemmed and hawed between candidates before finalizing a decision on the next appointed Commissioner of the FDA this past Friday.

Last week, Dr. Scott Gottlieb just barely nosed ahead of frontrunner, crowd-favorite, and billionaire-backed Jim O'Neill—both are venture capitalists not only well-versed in policy reform, but because both have a history working for the FDA, they are also equally familiar with everyday FDA operations. However, it was Dr. Gottlieb, a New York physician by education and policy reformer by trade, who received Pres. Trump's official nomination as the new Commissioner of the FDA. 

As a very vocal contributor to public discourse on the topic of medical and clinical policy reform, Dr. Gottlieb has provided not only numerous articles published in Forbes, The Chicago Tribune, Health Affairs, and The Wall Street Journal, among many others, but also made television appearances on CNBC and Fox News—a list sure to grow exponentially as he makes his way around the interview circuit promoting his recently clinched political promotion. If there's any wonder in precisely how Dr. Gottlieb plans to reform the FDA once sworn in, one needs to look no further than the numerous op-eds and articles he's written on just that topic.

One such piece, published in Forbes, highlights in bright and vivid shades the underlying issues pervading the FDA and CTP, describing the two as "being precariously balanced between fulfilling its mandate to encourage the production of reduced-harm products and satisfying the anti-tobacco zealots whose influence has grown since the TCA passed." This news inspires much hope in the hearts of vaping advocates as they await with baited breath for the retraction of the FDA "deeming regulations" which are overwhelmingly agreed to be outlandishly executed and rashly conceived.

Between his extensive education and the diverse professional positions he's held over the years, Dr. Gottlieb's background is as enriched with medical knowledge as it is with familiarity with public policy and regulation reform. 

Beginning the better half of his education at Wesleyan University in Middletown, CT where he majored in Economics, Dr. Gottlieb later received his eight years of medical training in New York between the Mount Sinai School of Medicine and Mount Sinai Hospital. 

Building upon an education balancing medicinal knowledge and economic concepts, Dr. Gottlieb has served and assisted the government in numerous capacities over the years, including serving as Director of Medical Policy Development, FDA Deputy Commissioner for Medical and Scientific Affairs, Senior Advisor for Medical Technology, and served as the Centers for Medicare and Medicaid Services' Administrator's Senior Policy Adviser just a number of months ago—all this after being a practicing physician and hospitalist for equally as long. 

Concurrently, he is a clinical assistant professor at the New York University School of Medicine, studies FDA policy-making as a resident fellow at the American Enterprise Institute—"a public policy think tank dedicated to defending human dignity, expanding human potential, and building a freer and safer world"—and serves as a member of the HHS' Federal Health IT Policy Committee.

Interestingly, Dr. Gottlieb currently serves as a member on the editorial board of a section of the JAMA and previously served as part of the British Medical Journal's editorial staff. Whether this connection will prove beneficial to the public masses or the corporate few, it's too early to tell, but having sway with one of the major sources of publications guiding a number of scientific decisions being made is sure to come into play as his career as Commissioner plays out.

Now, is that to say that Dr. Gottlieb is being sent to the top of a massively influential regulator of medicinal products without any kind of conflict of interest or outside influence? 

Well...I mean, of course not.

Previously a director to Bravo Health and Molecular Insight Pharmaceuticals (MIPI), Dr. Gottlieb currently serves as a director to American Pathology Partners, Medavante, and Aptiv Solutions, and is or was recently a member of several company boards, including 

  • Gradalis Inc.
  • CombiMatrix Corp.
  • Bravo Health, 
  • Molecular Insight Pharmaceuticals Inc
  • GlaxoSmithKline’s Product Investment Board. 

But the benefits he receives from large Pharma companies doesn't stop at title alone: according to data provided by the Centers for Medicare and Medicaid Services' Open Payment system, he's spent years receiving consulting fees in the range of hundreds of thousands of dollars from countless Pharma companies, including:

  • Pfizer
  • Vertex
  • AstraZeneca
  • Baxter
  • Insys
  • Daiichi Sankyo

and many more. 

Exactly how many more corporate ties he has hanging in his closet can be difficult to gauge, considering that, as a current venture partner at prominent capital firm New Enterprise Associates Inc, he has made countless far-reaching connections, both benign and malignant, over the years.

But just as Mitch Zeller, Dr. Califf, Jack Henningfield, Dr. Krishnan-Sarin and such figureheads of the FDA have gone straight from shaking hands with Big Pharma elite to deciding which of their medical products to approve, it remains to be seen if Gottlieb will play into their hand or if he will truly guide the FDA to do what is right for the people and small businesses. One thing to consider is his favorable view among Big Pharma companies, garnering a 72% approval rating from the 53 drug companies polled by a Mizuho Securities USA survey.

"At NEA, he has been an effective leader, helping guide our portfolio of companies as they seek to develop breakthrough advances in medical care," said David Mott, head of NEA's healthcare investing practice.

Hopefully, Dr. Gottlieb won't be too eager to bring that same willingness to lead drug companies to overcome challenges as he puts them through the ringer when approving their submitted experimental products, which is exactly what the disapproving few fear most, claiming that he'll undo decades of drug safeguards—a wild claim without much merit, sure, but still worth keeping ahead of hindsight as a potential worst-case scenario. Regardless, if there were one thing to undo, it would most likely be the "deeming regulations" on the vape industry that he has been very vocal in opposing both in spirit and at the earliest opportunity. 

Well, Dr. Gottlieb, it's your time to shine. We're hoping that you prove to be part of the solution that we need! Leave us a comment and let us know your thoughts or concerns regarding the newly appointed Dr. Scott Gottlieb. Will he be a saving grace for vapers, a champion for small business e-juice companies and vape shops, or do you think the changing of the guard will only lead to business as usual for the FDA?