Article Summary:
This Week at FDA highlights several significant regulatory developments. The most notable announcement came from FDA Commissioner Marty Makary and CBER Director Vinay Prasad, who revealed in the New England Journal of Medicine that the agency will now require only a single pivotal clinical trial for most drugs, departing from the decades-old standard of requiring two confirmatory trials.
The FDA reversed its initial refuse-to-file decision on Moderna’s mRNA influenza vaccine after the company proposed a revised regulatory approach involving full approval for adults 50-64 and accelerated approval for those 65 and older. Reports suggest this reversal followed President Trump’s frustration with the agency’s vaccine handling, though White House officials denied presidential involvement.
Commissioner Makary advocated for expanding over-the-counter drug availability, stating that medications should only require prescriptions if they’re unsafe, need laboratory monitoring, could be used nefariously, or are addictive. This aligns with administration efforts to lower drug prices.
In personnel changes, NIH Director Jay Bhattacharya became acting CDC director after Jim O’Neill’s dismissal—the fifth director removed this year.
Other updates include: AstraZeneca’s Calquence receiving approval for chronic lymphocytic leukemia treatment; upcoming meetings on rare disease data sharing and generic drug development; FDA recognition of updated international medical device standards; and a safety alert regarding Trividia Health’s glucose monitoring system manual error that could delay treatment for high glucose events.
The Duke-Margolis Institute and FDA will co-host a March 30 meeting on rare disease data sharing practices.