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Missing Data: One Long-Term Lesson From US FDA Action On Hydroxychloroquine

 
• By Michael McCaughan

Politicization of COVID-19 treatments is one of the unexpected wrinkles amid an unprecedented pandemic. But one lesson from the hydroxychloroquine experience in the US is more typical if still troubling: almost no one followed the rules on reporting follow-up data.

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The US Food and Drug Administration’s handling of the authorization allowing emergency use of hydroxychloroquine and chloroquine for treatment of COVID-19 will inevitably be viewed as a test of the agency’s independence in the context of the Trump Administration.

The 15 June revocation of the EUA granted for the products will certainly weigh heavily in favor of FDA’s independence...

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