Ill-advised right-to-try bills are spreading like kudzu through state legislatures. Now federal legislators want to insert right-to-try language into the bill that funds FDA drug approval. Given the support of powerful Republicans like Vice President Mike Pence for right-to-try, is it too late to stop this juggernaut and protect patients?
A week after Donald Trump was elected, I speculated about how he would affect medical science policy. Now, 80 days into the Trump administration, we have some observations.
Donald Trump versus the FDA: Is the standard of evidence for drug approval actually too low rather than too high?
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?
Donald Trump's three most likely picks for FDA Commissioner all favor loosening drug approval standards. Two are cronies of Peter Thiel, of which one believes that the FDA shouldn't require evidence of efficacy, only safety, and the other believes that a "Yelp for drugs" would do a better job than the FDA. The third candidate is a bona fide, honest-to-goodness pharma shill....