After a backlash, the FDA stages a face-saving pivot

In the span of a week, Moderna lurched from one announcement that the FDA had refused to even review its mRNA flu vaccine to another that the agency had agreed to take a look after all. It's a welcome reversal for both the company and the industry, STAT's Matthew Herper writes, but it's also yet another signal that a once-methodical agency is now operating with unnerving volatility.

Vinay Prasad, head of CBER, overruled staff to issue the rare "refuse-to-file" letter over concerns about Moderna's comparator in older adults, even though the agency had previously deemed the trial design acceptable. Now, in what feels like a procedural compromise, the FDA will consider full approval for adults 50 to 64 and accelerated approval for those 65 and older, forcing Moderna into another study to secure full approval in the older population.

The episode fits a broader pattern, Matt observes: dramatic regulatory moves, public sparring with sponsors, rejected gene and cell therapies, and a growing sense among industry and FDA staff alike that precedent is no longer a reliable guide.

psychedelics

Opinion: Psychedelics need community, not just capital and chemicals

Erica Rex — who first took psilocybin in a 2012 clinical trial at Johns Hopkins University to treat cancer-related depression — opines for STAT that psychedelics are powerful but profoundly context-dependent tools. Their benefits hinge on ritual, community, and careful integration, not just pharmacology.

Rex, who wrote the book "Seeing What Is There: My Search for Sanity in the Psychedelic Era," credits structured, well-supported experiences with lasting healing. She warns that today's commercialization of psychedelics is stripping away the communal "container" that tempers ego inflation, vulnerability, and potential abuse.

These risks, she notes, were underscored by controversies involving Lykos Therapeutics and by historical cautionary figures like Charles Manson. Rex draws on insights from psychiatrist Humphry Osmond and contrasts classic psychedelics with MDMA's oxytocin-driven suggestibility, ultimately contending that without community safeguards, psychedelics can amplify narcissism as easily as humility.

glp-1 drugs

Opinion: When weight loss becomes too much

The ethical dilemma around GLP-1 drugs has flipped, in the view of Harvard endocrinologist Jody Dushay: After years of shortages and rationing, clinicians are now confronting patients who don't want to stop losing weight. While most patients are "average responders" and a small fraction are nonresponders, a subset lose 25% or more of their body weight — sometimes far beyond what is medically advisable — and struggle to accept a plateau.

Opining for STAT, Dushay describes the tension of urging dose reductions or discontinuation when appetite suppression veers into food avoidance, social withdrawal, muscle or bone loss — or, worryingly, disordered eating. GLP-1s are powerful tools, she says, but weight alone is not a proxy for health, and clinicians have a responsibility to step in when the pursuit of a lower number on the scale starts to undermine physical or mental well-being.

fda

With CBER chief under pressure, 'Prasad stocks' pop

As FDA biologics chief Vinay Prasad comes under increasing scrutiny — after rejecting or delaying several rare disease and gene therapy applications and then reversing course on Moderna's mRNA flu vaccine — shares of companies that have recently felt his regulatory sting jumped yesterday. Capricor Therapeutics and Replimmune Group were up nearly 11%, and uniQure and Solid Biosciences rose nearly 8%. (Regenxbio dipped slightly.)

The rally follows weeks of industry anxiety over Prasad's tougher stance on surrogate endpoints, single-arm trials, and accelerated approvals in rare diseases. This posture, according to critics, signals a shifting of goalposts and has chilled investment, particularly in the mRNA space. Now, however, with political and public pressure mounting after the Moderna episode, there's buzz that there could be a turnaround.

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