That transparency isn’t normal.
When the US Food and Drug Administration rejected an antidepressant as a treatment for COVID-19 on Monday, it also released a 27-pageexplaining exactly why it wasn’t convinced the drug was effective. It’s an unusual move for the agency, which typically rejects drugs quietly without quite so much publicly available paperwork.
The antidepressant fluvoxamine is a cheap, generic drug that’s been used for decades. Research shows that the drug can also block inflammation in the body. So, some researchers hoped that it could help prevent severe symptoms in patients with COVID-19, some of whom have to cope with inflammation due to overactive immune systems.it might be able to reduce the risk of patients with COVID-19 getting seriously sick. But that research wasn’t enough to convince the FDA.
It’s uncommon to get this type of window into the FDA’s decision-making process when it rejects a drug. Most of the time, the decision goes to the pharmaceutical company who made the drug, and it’s kept confidential.that those companies often don’t announce rejections, and if they do, they don’t say publicly the reason why.
Notably, the use of fluvoxamine as a COVID-19 treatment wasn’t sent to the FDA by a pharmaceutical company — a group of doctors asked the agency to authorize it. Because it’s an old and generic drug, no pharmaceutical company would profit from taking it through the expensive regulatory process. One of those doctors, the University of Minnesota infectious disease physician David Boulware, criticized the FDA’s rejection, telling
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