FDA Commissioner Scott Gottlieb Unexpectedly Resigns After Busy Two Years
Food and Drug Administration (FDA) Commissioner Scott Gottlieb is stepping down after less than two years in office – a move that came as a surprise to his supporters and his critics.
The 46-year-old Scott Gottlieb is an interesting combination of physician and venture capitalist. He was sworn in as President Trump’s FDA Commissioner in May 2017. Gottlieb will stay on at the FDA until the end of March; a successor has not yet been named. The FDA Commissioner was respected by both Republicans and Democrats, even though he was a Trump nominee. In January, he tweeted that the rumors about his FDA departure were unfounded, stating he was definitely staying because the FDA had so much important work to do.
Although his resignation comes as a surprise, the parting seems to be an amicable one, with both President Trump and Health Secretary Alex Azar praising Gottlieb’s efforts. In fact, Gottlieb himself talked about how wonderful his time at the FDA had been and that leaving is a very difficult decision.
Tough on Big Pharma
While at the FDA, Scott Gottlieb accomplished a great deal in two short years. He did his best to improve the reputation of the FDA for moving at a snail’s pace regarding new drug and medical device approvals. Not only did the FDA break records at delivering more affordable generic drugs, Gottlieb was very aggressive with drug manufacturers, going so far as to publicly shame those that pulled tricks to prevent competitors from bringing new drugs to market. Under Gottlieb’s leadership, the FDA revamped an antiquated 40-year-old process for approving innovative treatments; he formed a new Digital Health team to approve the incredible influx of software and digital devices now emerging in health tech.
In the midst of all of these accomplishments, his efforts have focused on two main areas: opioid addiction and increasing regulations around youth use of tobacco and vaping. He has called the youth vaping craze an “epidemic” and strongly advocated for restricting sales of vaping liquids at convenience stores. However, those regulatory changes have not been implemented, and may not ever be, given his departure.
Several groups that advocate for “tobacco-less” youth praised Gottlieb’s position, stating that his proposals would have left an indelible mark, had Gottlieb only stayed long enough to finish the actions. The disappointed advocates worry that unless Gottlieb pushes those measures through before he leaves, they’ll likely never be adopted industry-wide, and the youth e-cigarette crisis will unfortunately continue.
Scott Gottlieb Resignation Relief for Vaping Industry?
On the other hand, Scott Gottlieb has been the nemesis of the vaping industry, stating that Gottlieb tried to over-regulate the industry and that his position was not consistent with President Trump’s promise for limited industry regulation.
Gottlieb knew his position would be liked by some and not by others, but described it as a careful balance to USA TODAY in a recent 2018 interview: “There’s many people who say we went too far and people who say we don’t go far enough.”
Gottlieb has indeed been very passionate about the risks of vaping, particularly in young people. He warned that teens are becoming regular users, and that the U.S. must take action before finding itself with yet another health crisis on its hands. Gottlieb said, “No one can look at the data and say there’s no problem.”
Scott Gottlieb served in a lesser capacity at the FDA nearly 20 years ago and has publicly reflected back on the mistakes that were made with opioids as a lesson and warning for vaping regulation. Gottlieb commented that the FDA could have and should have regulated opioids much more closely.
The similarities are too blatant not to notice. There was considerable pressure from big pharma to not interfere and to not over-regulate opioids because of the incredible market opportunity for financial gain that was made. Many vaping opponents say that history is repeating itself, with the new industry crying foul at overregulation in an industry that, like opioids, offers incredible promise for money to be made. Either way, Scott Gottlieb’s resignation will be a relief for the vaping industry, at least until a successor is named.