Trump Might Nominate an FDA Chief Who Doesn’t Much Like the FDA—or Governments

Talk about the fox guarding the henhouse. Libertarian Jim O’Neill is not much known in, as the president-elect would call it, “the swamp”—that is, among the powerful in Washington. But he does have a reputation in the biotechnology industry and his name is being put forward by a member of Trump’s transition team.

As STAT reports, O’Neill talked about his disdain for the FDA approval process at a meeting on regenerative medicine in 2014, using as inspiration his days working for the Department of Health and Human Services. He said that, as a libertarian, he is “inclined to believe that the regulatory costs that the FDA impose kill a lot of people and provide a lot of harm to the economy….”

O’Neill thinks that the FDA should allow companies to simply prove that drugs are safe before they’re put on the market—not that they actually work. “Let people start using them, at their own risk.”

It’s the bureaucracy that really appalls him, as STAT reports. “Every time the FDA commissioner approves something and someone gets sick who used it, the commissioner is summoned to a congressional committee that also controls his budget and forced to testify under oath, why he made this rash decision…. It’s a miserable process.”

He also thinks that people should be allowed to sell their organs. “There are plenty of healthy spare kidneys walking around, unused.”

He doesn’t much like government, either. O’Neill is on the board of the Seasteading Institute, an organization that wants to create floating city states, because existing governments are too cumbersome and ineffective.

O’Neill went to Yale, and earned his master’s degree from the University of Chicago. After being a speechwriter for the Department of Education, O’Neill went to work for HHS in 2002, where he eventually became principal associate deputy secretary.

At some point, O’Neill became interested in biotechnology, making it one of the focuses of the Thiel Foundation and Breakout Labs, which funds start-ups.

Another name being floated as the next FDA chief is Scott Gottlieb, MD, the focus of a Q&A in Managed Care in September 2016. That interview is filled with a lot interesting ideas. For instance, here’s Gottlieb on how to control drug prices based on value because it “would allow drug prices to adjust more readily. We are talking essentially about Part D, also Part B, where drugs have one price in the market, regardless of how they are being used, or that drugs are priced based on volume rather than the indication for which they are being prescribed or the outcome they achieve. You cannot adjust a drug price because of all the regulation. What we propose is providing more flexibility and reforming some of these rules to allow companies to reprice drugs based, for example, on how it might be being prescribed.”

Source: STAT