Ousted BARDA Director Bright Says Hydroxychloroquine EUA Distracted From Coronavirus Work
Rick Bright also tells House hearing that CDER Director Woodcock alerted him to the potential of the drug as a coronavirus treatment.
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Coronavirus Notebook: US FDA Cuts Hotline Hours, Regulatory Relief May Be Permanent, Trump's Hydroxychloroquine Prescription
Dispatches from a world turned upside down include approval of more hydroxychloroquine ANDAs, a window into what post-pandemic regs at the US FDA might look like, and some bad news for night shift works who need coronavirus advice from the agency.
In whistleblower complaint, Rick Bright claims FDA Commissioner Hahn advocated for distributing hydroxychloroquine to pharmacies across the US, a departure from the approved emergency use authorization. Bright's complaint paints CDER Director Woodcock in a favorable light, saying she helped avoid an expanded access IND protocol for the potential coronavirus treatment.
As potentially life-threatening heart problems emerge in coronavirus patients, FDA says hydroxychloroquine should be taken only in clinical trial or hospital settings under the Emergency Use Authorization.