President Trump—as he has done with other cabinet and agency picks—is keeping Congress and the public guessing about his choice for the next FDA Commissioner. Possible candidates to succeed outgoing Commissioner Dr. Robert Califf range from a severe critic of the FDA who advocates disbanding the agency to a policy conservative but defender of the FDA.
According to Robert Califf, M.D., the new commissioner will need the ability to balance evidence-based benefits and risks across a spectrum of consumer products, ranging from food and cosmetics to medical products and tobacco. This requires a workforce that can produce reliable products with transparent information for which the public has clearly expressed a need.
“The FDA commissioner should ideally have a deep understanding of these issues and a fluent ability to interact with the ecosystem, including the industries, patients, consumers, healthcare providers and politicians,” Dr. Califf told CenterWatch.
Katherine Hempstead, Ph.D., a senior advisor at the Robert Wood Johnson Foundation, also mentioned the need for a competent workforce in place at the FDA.
“There are hundreds of vacancies in the FDA, and there was concern about building [a] staff with the right skills to understand the many changes in both biomedical science and also evidence generation,” Dr. Hempstead told CenterWatch.
She echoed Dr. Califf in that another challenge for the FDA is the trade-off between safety and speed.
“I think that is what is most visible to the public,” she said.
Finally, Dr. Hempstead said the FDA must play a constructive role in promoting competition in the drug and device markets.
So who is President Trump considering for the next FDA Commissioner?
Last week, BioSpace reported that Joseph Gulfo, M.D., the former CEO and president of MELA Sciences and now senior fellow at Progressive Policy Institute, is a top candidate for the post. He has reportedly met with the Trump transition team twice.
According to STAT, Gulfo has a conservative bent, but sees the FDA and its mission as a legacy worth supporting. Gulfo believes that Congress needs to stop humiliating the FDA at hearings.
“I don’t think I’m calling for a major overhaul. ... I want to get back to [the] original intent of the law,” Gulfo said in a recent article on the Regulatory Affairs Professional Society website. “What I’ve proposed is getting FDA back to safety and effectiveness ... and we can do this one of four ways: with biomarkers, clinical science and symptoms (ie. blood pressure, tumor size), with disease modification (bouts of migraines per month) and lastly with long-term outcomes.”
Three other candidates mentioned recently are Scott Gottlieb, M.D., Jim O’Neill and Peter Thiel. All three of these candidates have similar backgrounds. This includes a mix of private venture capital work and public federal government service in health and human services or with the FDA. It’s fair to say all three are proponents of the free market system to improve drug therapy and medical device delivery. This fact concerns some.
“The [medical device] industry is falsely using innovation as a manipulation to evade the law and it’s harming and killing people,” Melanya Lokosky, CEO of MMpiHer and a medical device fraud expert advocate, told CenterWatch. Lokosky helped the U.S. Department of Justice recover $18 million from Johnson & Johnson in a whistleblower case.
One final person that recent news posts have keyed in on as a leading candidate is Balaji Srinivasan, the co-founder of Counsyl. He is also reported to be an advisor to Peter Thiel. Srinivasan is highly critical of the FDA and has, in the past, advocated disbanding the agency. Recent media reports speculate that he is the frontrunner.
“Neither O’Neill nor Srinivasan have significant medical or scientific background, which would fit into the idea that Trump hopes to disrupt the FDA,” stated a post on the BioSpace website.
With President Trump already pursuing his campaign promise to lower drug prices and streamline the FDA, there is a school of thought that big pharma is not really interested in an FDA overhaul.
“In fact, the pharmaceutical industry has long recognized the benefit of an efficient, rigorous FDA regulatory system that brings to market therapies able to demonstrate a certain level of safety and efficacy to gain acceptance from clinicians, patients and payors that set coverage and reimbursement levels commensurate with value,” PharmaExec.com posted in an article last week.
The site went on to further advocate that FDA approval under the current structure sets a “highly prized gold standard” that garners market approval, bolsters exclusivity and enhances market position.
The only quality Trump has stated publicly is that he wants a “fantastic person” to serve as the next FDA commissioner, but a gold standard structure is surely in line with President Trump’s core values. Stay tuned.
This article was reprinted from Volume 21, Issue 05, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »