President Trump will likely nominate Dr. Scott Gottlieb as head of the FDA. Though he is presently a resident fellow at the conservative American Enterprise Institute and a partner at a large venture capital fund, he used to be an FDA deputy commissioner known for advocating dramatic reforms in the process to approve new medical products.
According to his statements as well as comments to people familiar with his thinking on the FDA, Gottlieb intends to shoot for the rapid approval of complex generics, ushering in a wave of less expensive rivals to some of the biggest blockbusters on the market. He's also likely to spur the FDA to follow the course laid out by agency cancer czar Richard Pazdur in speeding new approvals, possibly setting up a special unit aimed at orphan drugs to hasten OKs with smaller, better designed clinical trials. Other potential reforms include the possible quick adoption of new devices that could be used to improve the kind of medtech Apple, Verily and others have been working on.
Gottlieb is viewed very favorably within the pharmaceutical industry as a regulatory reformer but not destroyer. If nominated, he will have been chosen over another high-profile name on the short list: Jim O'Neill.
The close associate of Peter Thiel, O'Neill famously suggested that drugs should be approved based on safety alone, letting consumers sort out what works. That left many fearing that Trump intended to toss out the regulatory framework for new drug approvals, raising fears that his idea of competition would allow de facto placebos to compete for market share.
(Score: 2) by gringer on Sunday March 12 2017, @08:19AM (2 children)
O'Neill famously suggested that drugs should be approved based on safety alone, letting consumers sort out what works
And how is this different from the current situation?
Ask me about Sequencing DNA in front of Linus Torvalds [youtube.com]
(Score: 0) by Anonymous Coward on Sunday March 12 2017, @01:46PM (1 child)
I have a hunch currently the drugs need to be both safe and effective.
May have something to do with the harm on the pocket of vulnerable people caused by plain water marketed as a cancer cure.
(Score: 2) by Immerman on Sunday March 12 2017, @03:49PM
In theory, but sadly only just barely in practice. There's fair number of drugs on the market that have been shown to be roughly as effective as placebos in independent testing. But so long as the manufacture can also manufacture tests showing how effective they are, they tend to get approved.