The news: Moderna’s new-style flu vaccine will get a full review after all as the FDA reversed its refusal to consider the company’s application. Moderna was initially denied a review for its mRNA flu candidate after FDA biologics division head Vinay Prasad overruled career scientists, per STAT—an unusual move that raised concerns about internal decision-making consistency.

The Moderna flip comes the same week that the director of the NIH Jay Bhattacharya also became acting director of the CDC—the fourth leader of that agency in less than a year.

Why it matters: The Moderna reversal and CDC leadership changes underscore ongoing uncertainty across federal health agencies.

Pharmaceutical and medical device companies rely on regulatory predictability to plan multiyear research cycles, manufacturing investments, and launch strategies.

• Drug development in the US takes 10 to 15 years, per pharma trade group PhRMA, and costs roughly $1.3 billion, according to a JAMA study last year.
• Even short delays are expensive; a single day of delay is estimated to cost $800,000 in lost prescription drug sales, per a Tufts study.

Implications for pharma companies: While the FDA’s reconsideration is positive for Moderna, it does little to ease broader industry concerns about regulatory consistency.

When companies aren’t confident about how rules will be applied—or whether decisions will stick—they take fewer risks. Drugmakers may delay investments, overprepare regulatory submissions, and build longer timelines into development plans across their pipelines.

That caution ripples outward, slowing product launches and marketing campaigns built around expected FDA decisions. In the longer term, ongoing uncertainty may push companies to pull back from innovation, especially newer platforms like mRNA, and focus on safer bets, potentially limiting future breakthroughs.

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