FDA’s Peter Stein And Lessons From Makena: There Are Limits To Regulatory Flexibility

Office of New Drug head said agency was willing to apply regulatory flexibility when it granted Makena its initial accelerated approval but says to give the drug the type of flexibility sponsor Covis wants now would set a ‘troubling’ precedent.

Makena - Nguyen and Stein
CDER’s Nguyen and Stein wrap up a persuasive round of ‘cross-examination’ of Covis at Makena hearing • Source: Screenshot of FDA hearing

If the 7 September Amylyx Pharmaceuticals, Inc. ALS advisory committee was the day that the US Food and Drug Administration put out the regulatory flexibility welcome mat, ushering sponsors to walk in, then Makena’s 17-19 October withdrawal hearing was the day it slammed the door in industry’s face.

FDA may have a legal obligation to exercise regulatory flexibility, but that flexibility is not infinite, and the Center for Drug Evaluation and Research used the three-day hearing on its proposal to withdraw Covis Pharma’s preterm birth

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