Politico has reported that the White House isn’t happy with the FDA’s recent actions surrounding vaccines, fueling public scrutiny of internal decision-making at the regulator.
The FDA’s quick change-up regarding Moderna’s seasonal flu vaccine application came on the heels of a meeting with President Donald Trump and FDA Commissioner Marty Makary in which Trump voiced frustration over how the situation has been handled, according to Politico. The publication cited “two people familiar with details of the meeting.”
A little over a week ago, Moderna reported that the FDA issued a refusal-to-file (RTF) letter in response to a request for approval of its next-gen flu vaccine candidate, mRNA-1010. In the letter, the FDA’s Chief Medical Officer Vinay Prasad, M.D., said the agency wouldn’t review the submission because Moderna’s comparator didn’t reflect the best-available standard of care in the U.S. at the time of the study.
Moderna then met with the FDA to discuss the situation and the agency quickly walked back its initial decision, accepting an amended application for review. The regulator is scheduled to make a decision by Aug. 5.
The revised filing splits the regulatory pathway based on age. Moderna is seeking full approval among adults 50 to 64 years and accelerated approval for individuals 65 and older. The accelerated approval proposal comes alongside a post-marketing commitment to run an additional study in older adults.
The first decision to deny the application review was reportedly made by Prasad, who overruled the agency reviewers, according to Stat News.
This isn’t the first time Prasad has been in the hotseat, with the leader departing the FDA last summer less than three months into his role as director of the Center for Biologics Evaluation and Research (CBER). His exit came amid a messy regulatory tug-of-war with Sarepta Therapeutics surrounding the company’s Duchenne muscular dystrophy (DMD) gene therapy.
Shortly after his ouster, Prasad rejoined the agency.
“Dr. Prasad’s kill shot last week is part of a broader pattern in which he has arbitrarily changed standards for approving new drugs and reversed the agency’s prior guidance,” the Wall Street Journal’s editorial board wrote in a Feb. 18 opinion piece. “The uncertainty is discouraging companies from launching new trials.”
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“The Trump team may find itself cleaning up after Dr. Prasad many more times in the next three years unless he gets the boot,” the Wall Street Journal team added.
When reached for comment, HHS spokesperson Andrew Nixon said, “As authorized under PDUFA and defined in FDA guidance documents, FDA held a Type A meeting with Moderna.”
“Discussions with the company led to a revised regulatory approach and an amended application, which FDA accepted,” Nixon continued. “FDA will maintain its high standards during review and potential licensure stages as it does with all products.”
As of publication, the White House has not yet responded to Fierce’s request for comment.
