The Makena Deciders: FDA Commissioner Califf, Chief Scientist Bumpus To Jointly Make Final Call On Drug’s Fate

 
• By Sue Sutter

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.

The Makena decision will be jointly made by FDA Commissioner Robert Califf and Chief Scientist Namandjé Bumpus.
The Makena decision will be jointly made by FDA Commissioner Robert Califf and Chief Scientist Namandjé Bumpus. • Source: Nielsen Hobbs; the Pink Sheet | images from Shutterstock, FDA

The final call on whether Covis Pharma’s preterm birth prevention drug Makena (hydroxyprogesterone caproate) stays on the US market or is withdrawn will be made jointly by two senior Food and Drug Administration officials at least three months after the 17-19 October public hearing.

FDA Commissioner Robert Califf and Chief Scientist Namandjé Bumpus “will collaborate on the decision and render the decision together as co-signatories,” hearing officer Celia Witten said in an 7 October...

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