Just ahead of the anticipated appointment of an FDA commissioner by President Donald J. Trump, there’s a bit of a buzz about a new candidate who is the fourth to be seriously considered for the job of regulating more than $1 trillion of annual economic activity.
All the candidates for FDA commissioner are focused on the processes for drug and medical device approvals, with foods and food safety getting hardly a mention. The confirmation hearings, however, are certain to bring out the Trump Administration’s plans for enforcing the Food Safety Modernization Act (FSMA).
Trump says his FDA appointment is coming soon, a schedule that may be falling into place now that Tom Price’s appointment as Secretary of Health and Human Services, FDA’s parent agency, has cleared the Senate Finance Committee. Price’s nomination now needs only a floor vote in the Republican-controlled Senate, which is seen as likely.
The new candidate for commissioner of the Food and Drug Administration is Joseph Gulfo, executive director of the Lewis Center for Healthcare Innovation and Technology at Fairleigh Dickinson University in Teaneck, NJ. Gulfo has a reputation as an FDA critic, but one with some very specific ideas about reform. He joins these others who Trump has under consideration:
- Jim O’Neill, managing director of Mithril Capital Management, a venture capital firm founded by Silcon Valley billionaire Peter Thiel.
- Balaji Srinivasan, a partner in the venture capital firm Andreessen.
- Scott Gottlieb, former FDA deputy commissioner who is now a resident fellow at the American Enterprise Institute and a partner with the New Enterprise Associates venture capital fund.
Like the three others, Gulfo has concerns about the length and complexity of the FDA’s drug approval processes, saying they have become so “onerous” that it is inhibiting drug development.
In numerous outlets covering the drug industry, Gulfo is getting attention for his plans to cut red tape at FDA. He’s says FDA has moved away from “safety and effectiveness” to operating out of “fear and it is not in the regulations.”
Gulfo is the co-author of a recent paper that argues FDA is “too restrictive,” going far beyond the safety and effectiveness standards required by law.
Stephen Ostroff, FDA’s commissioner for food and veterinary medicine, has been serving as acting FDA commissioner since Jan. 20, when Robert Califf stepped down. It is Ostroff’s second stint as acting FDA commissioner. He headed the agency temporarily for ten and a half months after FDA Commissioner Margaret Hamburg left and before Califf was confirmed to succeed her.
FDA’s regulatory authority reaches across about 20 percent of the U.S. economy, including human food, animal feed, veterinary medicines, pharmaceuticals, medical devices and various supplementals.
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