Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in MobiHealthNews, in “Gottlieb, Whose FDA Made Major Strides in Digital Health, Resigns as Commissioner,” by Jonah Comstock.
Following is an excerpt:
FDA Commissioner Dr. Scott Gottlieb has handed in his resignation as head of the agency, according to a report in the Washington Post, which has been confirmed by HHS Secretary Alex Azar in a statement posted to his Twitter page as well as by Gottlieb himself later in the day. He will resign in one month. …
Gottlieb has served as commissioner since mid-2017, but prior to his appointment some fairly extreme choices were rumored to be on Trump’s short list: Jim O’Neill, managing director at Peter Thiel’s Mithril Capital Management, and Balaji Srinivasan, founder of genomics company Counsyl. As we noted at the time, both are strongly anti-regulation. O’Neill has said that he would like to see the FDA shed its efficacy-evaluating functions and focus only on safety. Srinivasan, in a now-deleted tweet, argued that ”a Yelp! for drugs” would be more helpful to consumers than the FDA.
It’s hard to predict who Trump will tap to fill the vacancy left by Gottlieb, but whoever it is will have at least two years to shape policy at the agency, at a moment when many aspects of digital health regulations are in flux.
“I think this creates an opportunity for President Trump to find someone who is more likely to work with the new Congress,” Bradley Merrill Thompson, a partner at Epstein Becker Green who has been one of the program’s critical voices, told MobiHealthNewsin an email. “I think that much of what is on FDA’s plate presently may well require the support of Congress, if not legislation. So having someone who has a good relationship with both sides of the aisle would be a positive.”