Right-to-try is now the law of the land. Unfortunately, it’s a law custom-made for the unethical who don’t mind taking advantage of the terminally ill.
On Wednesday, President Trump signed a federal right-to-try bill into law with great fanfare, making extravagant claims for it. It’s time to reiterate one last time that right-to-try will not help terminally ill patients but it will strip important protections from them. It’s pure snake oil.
Earlier this week, the FDA issued draft guidance that would, if adopted, allow it to regulate homeopathic remedies as drugs. Will 2018 be the year that the FDA finally stops deferring to homeopaths and regulating homeopathic remedies as drugs?
Last week, the FDA released final regulatory guidance regarding freestanding stem cell clinics. The new regulatory framework appears custom-made to allow the FDA to crack down on quack stem cell clinics. But will it?
I’ve discussed so-called “right-to-try” laws, which promise to speed experimental drugs to terminally ill patients, but which in reality are about weakening and bypassing the FDA. Now über-Libertarian Peter Thiel is trying a new tactic to bypass the FDA by organizing an offshore clinical trial of a new herpes vaccine based on dubious science and not overseen by an IRB to protect patients. Both right-to-try and this trial are different fronts in the same fundamentalist free market war on FDA regulation.