President Trump’s vow to overhaul the
Food and Drug Administration could bring major changes in policy, including steps to accelerate the process of approving new prescription drugs, setting up a clash with critics who say his push for deregulation might put consumers at risk.
Mr. Trump has been vetting candidates to run the agency, which regulates the safety of everything from drugs and medical devices to food and cosmetics. Among them is Jim O’Neill, a former official at the Health and Human Services Department who is an associate of the Silicon Valley billionaire and
Trump supporter Peter Thiel. Mr. O’Neill has argued that companies should not have to prove that their drugs work in clinical trials before selling them to consumers.
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Mr. O’Neill’s stance has drawn the most attention. He is a managing director of Mithril Capital Management, an investment firm Mr. Thiel co-founded, and previously led the Thiel Foundation, Mr. Thiel’s philanthropic organization. During the George W. Bush administration, Mr. O’Neill held a series of roles in the Health and Human Services Department, including as principal associate deputy secretary, where he worked on policy, including for the F.D.A., according to his https://www.linkedin.com/in/jim-o-neill-5703138/.
Mr. O’Neill is a libertarian who is on the board of
the SENS Research Foundation, a charity that funds anti-aging research, and until recently served on the board of the Seasteading Institute, an effort to create new societies at sea.
At an anti-aging conference in 2014,
Mr. O’Neill advocated something he called “progressive” approval, in which drugs that were proved safe, but not yet proven effective, could be allowed on the market. “Let people start using them, at their own risk,” Mr. O’Neill said. “Let’s prove efficacy after they’ve been legalized.”
Some have suggested that a commissioner determined to weaken the efficacy standard need not seek congressional action, but could interpret existing regulations loosely so that requirements for certain clinical trials — particularly the costly, large-scale ones that can take years and involve thousands of patients — can be rolled back.
That could have serious implications for patients. Last month,
the F.D.A. released a study of 22 drugs that appeared promising in early studies but failed in final, large-scale trials.