FDA revised rules for expedited approval

Washington -- The FDA announced today that it was expanding its list of surrogate endpoints which can be accepted as evidence for expedited approval of therapeutic drugs.  The new rules can make it easier and quicker for drug companies to get a drug approved but have been criticized since surrogate endpoints, such as viral load or tumor growth, are not always a reliable measure of a drugs effectiveness.  FDA Commissioner Stephen Hahn today announced the inclusion of a new surrogate "A very smart guy has a good feeling about it."  The change seems to have been instigated after the Friday news conference where President Trump touted the possible benefits of chloroquine, which has not yet gotten FDA approval for treating COVID 19.   Dr. Hahn made clear that although the proposed rule was still in the comment period the standard would be rigorously applied.  "It can't be just any guy. It has to be someone who in their own opinion is very smart."  Further more, he noted "They either have to "have a good feeling" about it or believe it could be a 'game-changer.'   Just being 'hopeful' or 'eagerly awaiting trial results' is not sufficient, he said.  Comments on the proposed rule made clear that many in scientific community had questions about the standard for demonstrating that the person in question knows anything about science or medicine.  "What if it is demonstrably clear that the guy in question is a fucking idiot?",  asked one pharmacologist.