Trump’s Rumored FDA Candidate Strikes Nerve

The possibility that President-elect Donald Trump could nominate Jim O’Neill, a Silicon Valley investor with no medical background and controversial views, as head of the Food and Drug Administration (FDA) is setting off alarm bells among some healthcare experts.

Bloomberg News reported Wednesday that O’Neill, a libertarian and associate of billionaire Peter Thiel, who is close to the Trump team, is under consideration for the FDA position. The agency oversees the approval of new drugs and is responsible for ensuring their safety.

O’Neill lacks a medical background, traditionally a prerequisite for the job, and has raised eyebrows with his past comments about overhauling the agency.

The most attention has fallen on O’Neill’s comments in a 2014 speech, where he called for changing the FDA’s mission so that it no longer considers whether drugs are effective when deciding whether to approve them. Instead, O’Neill said the agency should only consider whether drugs are safe.

“We should reform FDA so that it’s approving 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 said. “But let’s prove efficacy after they’ve been legalized.”[…]

Diana Zuckerman, president of the National Center for Health Research, said that O’Neill’s idea of having the FDA no longer consider whether a drug is effective would cause chaos because insurance companies would no longer be able to use FDA approval to decide which drugs they would cover, and possibly could have to start making those determinations on their own.

“It would throw the entire U.S. healthcare system into turmoil,” she said.

To read the full story, click here.