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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 c0lo on Sunday March 12 2017, @10:56PM (3 children)
Ok, I got the numbers. What I don't get is: what you see as "FDA roadblocks pre-clinical trials" which need to be removed?
The only way that I see the higher chances of a new drug to be proven effective and safe with reduced costs is to have the drugs failing the process as soon as possible thus removing extra cost in advanced steps.
Do you see some other way here?
https://www.youtube.com/watch?v=aoFiw2jMy-0 https://soylentnews.org/~MichaelDavidCrawford
(Score: 1) by khallow on Monday March 13 2017, @06:42AM (2 children)
(Score: 2) by c0lo on Monday March 13 2017, @07:26AM (1 child)
Those hoops, added or removed?
If removed: how this is going to drive down the costs if the drug turns out to be toxic? Given that human testing is much expensive than testing on model animals, I believe its their interest of doing the best the pharmas can in pre-clinical trials, when the costs are lower.
If added: how's this removing roadblocks from pre-clinical trials?
I'll let aside we are barely at the level of cloning organs (from stem cells), much less at the level of cloning humans without brains.
What stops them from using any line of immortal cells [wikipedia.org]? At least the toxicity can be (partially) evaluated on a cell closer to human than any model animal.
https://www.youtube.com/watch?v=aoFiw2jMy-0 https://soylentnews.org/~MichaelDavidCrawford
(Score: 1) by khallow on Monday March 13 2017, @02:59PM
If removed: how this is going to drive down the costs if the drug turns out to be toxic?
It allows the drug company to solve that problem as they see fit before it gets to human testing.
What stops them from using any line of immortal cells?
As I recall, for a time, certain lines were banned from federal funding by the Bush administration. And the higher level Department of Health and Human Resources was for a time the means by which a ban on the funding of anything derived from human fetuses was enforced. There is a history of interference here.