FDAnews
www.fdanews.com/articles/199344-court-denies-call-for-fda-to-approve-hydroxychloroquine-treatment-for-covid-19

Court Denies Call for FDA to Approve Hydroxychloroquine Treatment for COVID-19

October 2, 2020

A federal court in Michigan has denied a demand from a physicians’ group for the FDA to renew its authorization for hydroxychloroquine as a coronavirus treatment.

The agency issued an Emergency Use Authorization (EUA) for the controversial anti-malarial drug in March, enabling hospitalized coronavirus patients to secure the drug from the Strategic National Stockpile, but only if they could not join a clinical trial. However, in June, the FDA nullified the EUA and said hydroxychloroquine was unlikely to be an effective treatment for COVID-19, citing cardiac problems and other adverse events.

The Association of American Physicians and Surgeons sued on behalf of its members. But the District Court for the Western District of Michigan noted that the association’s member physicians “remain free to prescribe the drug from the commercial market if they so choose.”

View today's stories