| Title | What a Gottlieb-Led FDA Might Mean for the Pharmaceutical Industry | |
| Date | Sunday March 12 2017, @03:05AM | |
| Author | Fnord666 | |
| Topic | ||
| from the time-to-market dept. | ||
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.
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