Two patients are in troubling health situations — one patient you know, and one you don’t. Their care experiences paint a wildly different picture of how the U.S. Food and Drug Administration (FDA) treats patients in need of immediate attention — and what should be done to ensure more access to innovative treatments when available.
One patient’s story is undoubtedly familiar to all Americans: After his COVID-19 diagnosis, President Donald Trump became the most high-profile beneficiary of the FDA’s Expanded Access program, often referred to as compassionate use, which allows the FDA to grant a seriously ill patient access to a non-FDA approved treatment. To treat the president, the FDA signed off on the compassionate use request for a coronavirus antibody cocktail, a treatment currently in clinical trials.
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