The US FDA And The Dog That Didn’t Bark
Commissioner Hahn’s role in the EUA for convalescent plasma has understandably roiled the world of FDA watchers. But what about the EUA that FDA still has not granted as a treatment for COVID-19?
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Emily Miller, who joined FDA a few days before its controversial roll out of emergency use authorization for convalescent plasma, remains at the agency. Situation shows importance of sticking to science-based decisions, former FDA officials say.
Bowing to President Trump’s latest push to authorize the anti-malarial drug for COVID-19 could damage the reputation of the agency for the duration of the pandemic and beyond, experts say, arguing it may be the best example yet of why the FDA’s decision making needs to be more clearly delineated from the country’s political leadership.
COVID-19 has helped demonstrate the viability of platform trials with a shared control arm. That model is easier to extol than it is for sponsors to embrace, especially outside of crisis mode.