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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 aristarchus on Sunday March 12 2017, @09:20AM (1 child)
Shortening the approval process for new drugs will save lives in the long run.
Unless they kill more people in the short run to the extent that they also kill more people in the long run. Do you not remember the 1950's? https://helix.northwestern.edu/article/thalidomide-tragedy-lessons-drug-safety-and-regulation [northwestern.edu] Yeah. And why is Peter Thiel, that vampire, involved in health care at all? Why should government be involved in safety, as opposed to effectiveness? Unless we have some proven drug, in double-blind objective studies, and can cure Republican Libertarian Really Creepy Gay Billionaire syndrome. (Do we, yet? What? No funding? OMG!) I say let the market decide. If a company sells drugs the kills their customers, they will just go out of business when the mechanism of the market kicks in! Right, khallow! That is why you just cannot by street heroin these days. Just can't do it. Can't buy Epi-pens, or AIDS medication, either, but that is a different issue.
(Score: 0) by Anonymous Coward on Sunday March 12 2017, @01:15PM
Hero-in.
I'm afraid the kills customers will go out of business before the mechanism of the market kicks in.
Ah, I see now, you were taking about a (as in "one") company going out of business.
Sorry, this singulars and those plural pronoun is making my non-native english head spin.
I'd better go to sleep now.
See you to morrow, buy-bye. Hero-out!