FDA’s At-Home Testing Screw-Up Is Undermining Promising New COVID Treatments

“On November 4, the United Kingdom’s regulatory authorities approved molnupiravir as a treatment for COVID-19 infections. Meanwhile, the U.S. Food and Drug Administration (FDA) continues to dawdle over approving medications that were so effective that independent Data Monitoring Committees ruled that it would be unethical to continue giving placebos to study participants.

Speaking of dawdling, the FDA has long stymied the development and roll out of another vital component for the effective use of these antiviral medications: namely, at-home COVID-19 testing. Both pills must be taken by people within 3 to 5 days of exposure or symptom onset to be most effective at preventing hospitalization and death. That means that people need to be able to test themselves quickly, easily, and cheaply.

Up until mid-October, the FDA had approved only two over-the-counter at-home COVID-19 diagnostic tests, one of which has now had to be recalled. In the last month and a half, agency regulators have finally gotten around to authorizing nine more.”

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