Political Appointees Shouldn't Influence Approval Decisions, Califf Says
FDA commissioner offers new details about why he left final decision on Sarepta's controversial Duchenne muscular dystrophy drug to FDA's expert bureaucrats.
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The two senior agency officials will render the decision together as co-signatories on whether Makena loses its accelerated approval or is allowed to stay on the market; that decision will not come before mid-January, and is likely to be weeks or months later, based on a timeline set out by hearing officer Celia Witten.
US FDA Still Hasn’t Decided Who Will Be Final Arbiter On Approval Status For Covis’ Makena
With two weeks to go before hearing on whether the preterm birth prevention drug can stay on the market or be withdrawn, the lack of clarity on who will make the ultimate decision may stem from the lengthy duration of the dispute and multiple transitions within FDA’s senior leadership.
The Case For US FDA To Be More Political In Its Approval Decisions
No one thinks it is a good idea for the US FDA Commissioner or some other higher up political actor to decide when and if to approve new drug applications. But it might not be so bad if the scientific staff at FDA paid a bit more attention to ‘political’ issues before making some decisions.