Tag: Centers for Medicare and Medicaid Services

So who is under consideration to run the Food and Drug Administration? Over the last two months, a number of names have been floated by individuals associated with the Trump transition team and several have been spotted at Trump Tower and even confirmed as considered appointments by the Trump team. Here are a few:

1. Dr. Scott Gottlieb: former deputy commissioner at the FDA under President George W. Bush, venture partner at New Enterprise Associates, and resident fellow at the American Enterprise Institute (AEI). For those of you who may not know, AEI is almost as big a fan of vapor products and their consumers as we are at ATR. I know, I’m biased. But go read anything Dr. Sally Satel has ever written or said on the subject if you haven’t. Hi Sally!Gottlieb is advising the Trump transition team and as a former regulator would make a more traditional pick to lead the agency. I’m led to believe this guy gets it when it comes to harm reduction and the importance of innovation in the vapor space. 
2. Jim O’Neill: closely connected to Trump supporter Peter Thiel, the billionaire businessman and venture capitalist who co-founded PayPal. O’Neill is managing director at Thiel’s Mithril Capital Management. He isn’t a doctor and doesn’t have a deep background in healthcare but did serve in W.’s HHS between 2002-2008.O’Neill has publicly expressed support for allowing drugs to hit the market after they’ve been deemed safe but before they’ve been deemed effective. See this Forbes piece on the “progressive approval” process. This would be what they call ‘UGE. Picking O’Neill would be one of those extremely bold shake up the FDA with a guy opposed to the status quo kind of things. 
3. Dr. Joseph Gulfo: the executive director of the Lewis Center for Healthcare Innovation and Technology at Fairleigh Dickinson University, and the former President and CEO of the medical device firm MELA Sciences. A defender of the FDA’s underlying mission but big advocate for reforms that simplify the drug-approval process. Click here to read an interview he did this week and a piece he wrote for the Wall Street Journal in November. He’s the newest name on the short list.
4. Balaji Srinivasan: another Silicon Valley entrepreneur connected to Thiel. He’s a partner at the VC firm Andreessen Horowitz, CEO of a bitcoin startup, and lecturer at the Departments of Statistics, and Computer Science at Stanford.

Okay, what do all of these possible picks mean for the FDA and the vapor industry? There’s clearly a push for someone from the tech/biotech industry to take the reins and it’s likely that the next head of the FDA will come from the venture capital world, bringing with them a better understanding of entrepreneurship, economics, and the importance of innovation than recently departed Commissioner Califf or his predecessor Commissioner Hamburg. These guys aren’t career practicing doctors, they’re investors and innovators. We’re on the verge of seeing big changes at the FDA.

Note: Mitch Zeller, the director of the FDA’s Center for Tobacco Products is not a political appointee. He’s under no obligation to leave the position and will likely stick around for a while. That’s why we’ll need a culture shift above him at the FDA and at HHS. Congressional action helps too.