US FDA Chief Scientist Hinton’s Departure Leaves Vacancy Atop Makena Decision Tree
Jacqueline O’Shaughnessy takes over as acting chief scientist following Denise Hinton’s move to the surgeon general’s office; Hinton previously had been tapped by acting commissioner Janet Woodcock to make a final decision on the accelerated approval status of Covis' preterm birth prevention drug Makena.
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The Makena Deciders: FDA Commissioner Califf, Chief Scientist Bumpus To Jointly Make Final Call On Drug’s Fate
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.
With two weeks to go before hearing on whether the preterm birth prevention drug can stay on the market or be withdrawn, the lack of clarity on who will make the ultimate decision may stem from the lengthy duration of the dispute and multiple transitions within FDA’s senior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.
Agency policy now allows several others, along with the FDA chief scientist, to authorize emergency use of products, including CBER Director Peter Marks, who signed the EUA for the modified dosing of the monkeypox vaccine.