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.
In less than two weeks, the Trump administration will have passed that magical "first 100 days" marker. Let's check in and see how Donald Trump is shaping federal biomedical policy thus far. Hint: It's deregulation über alles.
All of the candidates being considered by President Trump for FDA Commissioner believe that the FDA is too strict in its standards for approving new drugs. In a commentary in Nature last week, two bioethicists argued that, at least in terms of preclinical data, the standard of evidence is actually too low. Which is correct?
I’ve seen it noted that our new President-Elect seems to be selecting his cabinet officers and directors of federal bureaucracies based on how much they oppose the mission of the department they are supposed to head. For instance, to head the Department of Health and Human Services, he picked an orthopedic surgeon who belongs to an organization utterly opposed to any role of the federal government in health care and who himself looks poised to dismantle as much of the Affordable Care Act as he can. For the Department of Energy, he picked Rick Perry, a man so dumb that …