January 24, 2017
By Alex Keown, BioSpace.com Breaking News Staff
WASHINGTON – There’s a new candidate to helm the U.S. Food and Drug Administration under President Donald Trump. Joseph Gulfo, the former chief executive officer of Mela Sciences (Strata Skin Sciences) is now one of the top candidates for the post.
According to Stat News, Gulfo has met with the Trump transition team on at least two occasions. Unlike other candidates who have been under consideration for the role, Gulfo does not have an antagonistic attitude toward the regulatory agency. Stat News cited a number of articles Gulfo wrote urging Congress to stop humiliating the FDA during congressional hearings. He said lawmakers should support FDA staff in their jobs and the decisions they have to make. What may have drawn the interest of the Trump team is Gulfo’s call for the adoption of four categories of drug approval. One point Gulfo made in his writings, Stat News said, is his call to approve some medicines that may not have long-term health benefits. Rather, Gulfo said the FDA should “consider whether the drugs lead to positive trends in biological parameters associated with the disease, such as glucose levels,” Stat News reported.
Gulfo currently works as executive director of the Lewis Center for Healthcare Innovation and Technology, at Fairleigh Dickinson University.
Other candidates to helm the FDA include Jim O’Neill, a longtime colleague of Trump transition team scientific adviser Peter Thiel, who met with Trump in December. O’Neill currently serves as a managing director of Thiel’s Mithril Capital Management. He has had government experience, most recently serving as principal associate deputy secretary at the Department of Health and Human Services in the administration of President George W. Bush. O’Neill has called for the FDA to allow for the approval of drugs “after their sponsors have demonstrated safety—and let people start using them, at their own risk, but not much risk of safety.” O’Neill also argued for a free-market approach to medication. In 2009, he said that kind of approach would drive drug prices lower and “allow innovation in cheaper delivery of care, both in terms of drugs and devices and better forms of delivery.”
Another potential FDA candidate is Dr. Scott Gottlieb, a former deputy commissioners at the FDA. Gottlieb has strong ties to the pharmaceutical industry and currently serves as an adviser to several companies, including GlaxoSmithKline .
Another potential candidate, Balaji Srinivasan, the co-founder of Counsyl Inc., has also been a harsh critic of the FDA. Also a close associate of Thiel, Srinivasan was known for using his Twitter account to criticize the agency for slow approval of new medications. In a tweet, Srinivasan has said that “before the FDA, scientists were able to take insulin from bench to bedside in two years.” He also said that “for every thalidomide though, many dead from slow approvals.” In addition to criticizing the FDA for slow approval of medications, Srinivasan has also used his social media platform to suggest disbanding the FDA and use an online ratings tool like Yelp for which drugs are most effective. In 2013, Bloomberg reported that Srinivasan proposed the idea of “a world run by software that could circumvent regulation.”
