In a Law360 article, AGG Food & Drug chair Alan Minsk commented on FDA’s reversal regarding Moderna’s influenza vaccine application and what the episode means for regulatory consistency and agency oversight.
The article examines FDA’s initial refusal-to-file letter, followed by its decision to review the vaccine after all, raising questions about predictability in the drug approval process. Alan noted that it is “unusual” for high-profile political appointees to be directly involved in decisions of this nature and observed that some companies have recently received unexpected complete response letters from FDA.
In some of the recent cases, Alan said the letters felt inconsistent with written correspondence with the agency leading up to that decision. In that situation, companies can feel like FDA is “pulling the rug from underneath them.”
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- Alan G. Minsk
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