On Sunday, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to the Health and Human Services’(HHS) Office of the Assistant Secretary for Preparedness and Response Biomedical Advanced Research and Development Authority (ASPAR’s BARDA) for hydroxychloroquine and chloroquine for coronavirus treatment. The agency allowed for the drugs to be “donated to the Strategic National Stockpile to be distributed and prescribed by doctors to hospitalized teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible,” HHS announced https://www.hhs.gov/about/news/2020/03/29/hhs-accepts-donations-of-medicine-to-strategic-national-stockpile-as-possible-treatments-for-covid-19-patients.html that Sandoz had donated 30 million doses of hydroxychloroquine to the stockpile and Bayer donated 1 million doses of chloroquine.
From HHS’ announcement: “An EUA may be issued if the FDA determines that, among other criteria, the known and potential benefits of the product, when used to diagnose, prevent, or treat the identified disease or condition, outweigh the known and potential risks of the product, and there are no adequate, approved, available alternatives. Emergency access to a medical product under an EUA is separate from use of a medical product under an investigational drug application.” Other than a requirement that doctors prescribing the drug be given a sheet explaining risks and drug interactions, there are no further restrictions on doctors. The donation of supplies by pharma merely eases the supply crunch but does not make the drugs free.
As of this Monday morning, the FDA had not yet mentioned this move on its site.
Thus, any doctor treating a patient with COVID-19 will be able to prescribe one of these drugs without fear of legal repercussions for use of an “unapproved drug”. News of the announcement came on Politico https://www.politico.com/news/2020/03/29/fda-emergency-authorization-anti-malaria-drug-155095, which of course tries to put a political spin on the move, which was championed by the White House and has no lack of detractors.
This is very good news, and only took 5 acronyms to explain. Good thing NASA isn’t handling the problem.