Re: In ‘Power Grab,’ Health Secretary Azar Asserts Authority Over F.D.A.
Definitely. Its about time.
It has nothing to do "with meddling" with science based evidence, but rather everything to do that with the fact that the FDA's Governance Risk Framework is flawed. You can't have proper "Risk Responses" to public health/national security emergencies if you can't properly define what a "Black Swan" event beyond basic "ensuring that drugs are safe". Since the FDA has no transparent and functioning framework for the approval of drugs in regards to "Total Lives Saved", as it does not have control over the time to manufactture and deliver live saving therapies and vaccines (as opposed to OWS), then it essentially has a flawed and arbitrary risk based framework. Moreover, it uses this lack of a functional framework to arbitrarily approve drugs and vaccines based not on OWS, but based on false promises received by it pharma industry counterparts.
Approval of Convalescent Plasma is a very good example. You can't warp speed supplies of CP. Absolute efficacy in terms of total lives save potential are therefore simply not comparable with say, Leronlimab. Failure to account for "time to impact", completely disregards the true black swan risk response or "total lives to be saved". The FDA has a broken Governance Framework.
It took a pandemic to see it and hopefully this will result with post-covid19 re-definition of the FDA/NIH/NIAID goverance as its current lack of properly defined governance frameworks are also the root cause to Amercica's absurd drug prices.