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The outside-the-lines approach to medicine fits Thiel's libertarian philosophy—and that of the FDA he's helping to reshape. KHN notes that Scott Gottlieb, who Trump tapped to run the FDA, has long opposed the agency's rigorous safety requirements. Trump himself has complained about the time it takes to bring new drugs to market, promising to streamline the process. Trump's proposed changes, not surprisingly, will more likely benefit corporations than consumers.Rational Vaccines is hoping that the FDA will approve its vaccine despite the fact that its trial didn't have oversight from an IRB. If the FDA denies the request, the company will do more testing in Mexico and Australia and "hopes" to set up an IRB for these trials. The results of the first trial have yet to be published in a peer-reviewed journal, and the first attempt to do so was rejected in part because of concerns over lack of safety and skepticism about Halford's scientific approach.And one investor in the company says the herpes trial is at least partly a political maneuver, designed to force the issue of medical testing regulation into the public eye. "This is a test case," Bartley Madden, a retired Credit Suisse banker and policy adviser to the conservative Heartland Institute, told KHN. "The FDA is standing in the way, and Americans are going to hear about this and demand action."Robert Califf, the most recent FDA Commissioner before Gottlieb, told KHN that he couldn't think of a single instance where American researchers operating abroad didn't set up an IRB, and doubted the FDA was getting in the way of herpes vaccines, saying the cost of bringing new treatments to market is high because treatments often don't work or are shown to be unsafe. "The FDA is not the problem," Califf said. "The issue is that there are so many failures."Meanwhile, there are at least three other herpes vaccines currently in development, including one that's already in phase three clinical trials and one that's being tested by the National Institutes of Health.Read This Next: How Trump's FDA Pick Will Shred the Healthcare Safety Net