The official statements from industry groups are already flooding in, following an unconfirmed report that President Trump is poised to nominate Scott Gottlieb for the role of FDA commissioner.
Reuters broke the news late Friday, citing sources familiar with the matter.
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If true, it’s not a major surprise. Pundits had narrowed the pool of possible candidates down to just a handful of names, including Gottlieb and Jim O’Neill. Balaji Srinivasan was believed to be in contention at the beginning of the year, but his long history of anti-FDA tweeting seems to have got the better of him.
O’Neill hadn’t been ruled out, though he did carry some radical views. In a February 2015 speech, he championed an extreme deregulation of the drug approval process, cutting back on efficacy requirements in favor of “real-world evidence.”
“We should reform FDA so it is approving drugs after their sponsors have demonstrated safety and let people start using them at their own risk,” O’Neill said.
In this line-up, Gottlieb is a safe option. The 44-year-old has been in and around the FDA for many years, serving as deputy commissioner for policy under George W. Bush. Based in Washington D.C., he now holds positions as a resident fellow at the American Enterprise Insitute and as a venture capitalist with New Enterprise Associates (NEA).
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In contributed articles and editorials, he is provocative but not radical. Gottlieb has written about a wide range of health-related topics, from Medicare to the spread of Zika virus in the United States.
Some articles directly prepare him for the top job as FDA commissioner.
In September 2016, he wrote in Forbes about a need for more rational drug pricing. It came in response to Mylan’s claim that its large price hikes on the EpiPen were in part due to the cuts taken by pharmacy benefit managers (PBMs). There was no easy solution given, but he expressed a need to tackle the tangled supply chain that continues to inflate the cost of healthcare.
A month later, he picked on Mylan again. Using the EpiPen as an example, Gottlieb opined on the challenges generics manufacturers face proving drug or device equivalency.
Congress should modernize the generic drug framework to accommodate complex drugs. It could start by giving FDA more discretion to rely on a broader complement of data for evaluating generic copies to complex drugs. This could mean granting FDA the ability to ask for more than just bioequivalence and bioavailability data when it comes to making judgments around sameness as it relates to complex drugs.
The list of carefully crafted editorials goes on. Taken together, Gottlieb seems to have run a sleek unofficial campaign to head the agency.
He has a tidy personal facebook page (well-known people typically use pseudonyms, so that’s notable) and a @scottgottliebMD public figure page with close to 15,000 followers. He has 35,000 followers on Twitter and has tweeted over 10,000 times.
Deborah Dunsire, CEO of XTuit Pharmaceuticals and a well-known industry leader, shared her personal impression via email.
“I would be delighted to see Scott Gottlieb as the Commissioner. He has good experience at the FDA and a strong policy background. He is very smart, learns quickly and also very good at engaging in discussion with different parties and hearing different viewpoints. The oncology division at the FDA has been a great example of what can be done to bring innovation to patients efficiently and effectively. It would be great to see more of the divisions take a leaf out of that divisions book.
It will be interesting to see whether he can maintain a calm and considered approach if confirmed as FDA commissioner. The current administration seems to have its own agenda for reform. Trump has been vocal about the need to remove FDA barriers and bring drug prices down, while Vice President Pence recently hosted advocates of the ‘Right to Try’ movement at the White House.
Photo: LinkedIn
