Over the weekend, the Food and Drug Administration (FDA) issued an emergency authorization for the use of hydroxychloroquine (HCQ) and chloroquine (CQ) to treat hospitalized COVID-19 patients. Simultaneously, the Department of Health and Human Services (HHS) announced that Sandoz has donated 30 million doses of HCQ and Bayer one million doses of CQ to the Strategic National Stockpile. According to HHS, these drugs will be “distributed and prescribed by doctors to hospitalized teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available.”
The effect of the FDA’s emergency authorization is unclear. The FDA regulates the manner in which manufacturers of pharmaceuticals may advertise and sell their products. If, after testing and clinical trials, the FDA approves a drug for a particular use, then the manufacturer may market it for that purpose and no other.
The FDA, however, does not set the standard of care for physicians and does not regulate the practice of medicine. That is why, even before the FDA’s “emergency authorization,” physicians have been free to make “off-label” (non–FDA approved) use of HCQ and CQ to treat COVID-19 patients.
Following clinical trials in China, South Korea, and France that demonstrated the efficacy of treating and likely preventing COVID-19 infections with HCQ alone or in combination with azithromycin, President Trump expressed to the media optimism about HCQ being a potential “game changer” in the fight to defeat the pandemic. But, at that same press briefing, Dr. Anthony Fauci seemed to throw cold water on Trump’s enthusiasm. In answer to a reporter’s question, Fauci stated that although there was “anecdotal evidence” that HCQ was effective in treating and preventing COVID-19 infections, controlled clinical trials of the drug were still necessary before any definite conclusions could be reached.
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See Also:
(1) The Game Changer: President Trump Was Right
(2) Twitter Removes Tweet Reporting ‘Hydroxychloroquine’ As Treatment For Wuhan Virus
(3) Brooklyn man arrested for hoarding masks, coughing on FBI agents
(4) Complicated Mathematical Models Are Not Substitutes for Common Sense
(5) Mortgaging America’s future for the sake of economic relief from coronavirus pandemic
