Why Won’t the FDA Let Doctors Prescribe Fluvoxamine for Covid?

Trials show it keeps patients from getting sicker, but the agency won’t approve its emergency use.

Following guidance from the CDC the Biden administration is appealing the decision to strike down the national mask mandate on public transportation. But it seems the appeal is about more than just the pandemic. Images: AFP/Getty Images Composite: Mark Kelly

The Food and Drug Administration is under attack for being too cozy with drugmakers, but there’s nothing wrong with regulators cooperating with private industry. That’s how we got Covid vaccines and therapies in record time. What’s rotten is that applications for new uses of generic drugs are reviewed under different standards than those for novel treatments. That’s what the FDA did this month when it rejected a Covid emergency-use authorization (EUA) application by doctors for the antidepressant fluvoxamine.

The media has derided some doctors as quacks for advocating off-label drugs like hydroxychloroquine and ivermectin. Early in the pandemic studies suggested the two anti-parasite drugs could be beneficial. David Boulware, an infectious disease specialist at the University of Minnesota, helped lead four of those trials. Yet he now strangely finds himself clashing with the FDA over its rejection of fluvoxamine.

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