You have probably all heard the news from the US: Scott Gottlieb has resigned from the role of FDA Commissioner (1). When he was first appointed, concerns were raised about his ties with the pharma industry, but Gottlieb will leave with his head held high. He has earned bipartisan praise, been highly active on drug pricing issues, helped speed up generic approvals, advocated for continuous processing and modern drug manufacturing methods, and been unafraid to call out abuse of any aspects of the system by drugmakers. And he has done all of this while still maintaining a good relationship with the industry. He’s also been active on other important healthcare topics; just a few weeks ago, he insinuated that certain states with lax vaccination rules may force the hands of regulators, given the shocking rise of measles outbreaks in the US (2).
Gottlieb will leave in about a month, but recruiting his successor is likely to take some time – and in the unpredictable Trump administration, no one knows what or who will come next. At the start of his presidency, Trump caused panic after meeting with Jim O’Neill to discuss the FDA Commissioner job. O’Neill has no medical or scientific background and, in a 2014 speech, allegedly said, “We should reform FDA so there is approving drugs after their sponsors have demonstrated safety – and let people start using them, at their own risk. Let’s prove efficacy after they’ve been legalized.” (3)
Although some are concerned that Gottlieb was pushed out of the administration for his tough stance on tobacco products, the reason for the resignation appears to be the commute to and from Connecticut, and Gottlieb’s desire to spend more time with his family (4) – a reason few can argue with. In this day and age, with so much technology that allows for remote and flexible working, it’s a shame that organizations can’t do more to support their talented workers – particularly those in highly demanding roles – to find a healthy work-life balance.
I wish Gottlieb all the best and hope that the next FDA Commissioner can pick up where he left off, continuing to encourage the industry to innovate and modernize without compromising on patient safety.
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References
- STAT, “FDA Commissioner Scott Gottlieb to Resign,” (2019). Available at https://bit.ly/2TyqjRH. Accessed March 6, 2019. CNN, “FDA Chief: Federal Government Might Step in if States Don’t Change Lax Vaccine Laws,” (2019). Available at https://cnn.it/2SOkw6a. Accessed March 6, 2019. MIC, “Jim O’Neill, Trump’s Potential FDA Head, Thinks Drugs Should be Approved Without Efficacy, (2016). Available at https://bit.ly/2Tllxri. Accessed March 6, 2019. Endpoints News, “Popular FDA Commish Scott Gottlieb Has Handed in his Resignation,” (2019). Available at https://bit.ly/2J4VS1k. Accessed March 6, 2019.
