Review: FDA authorizes emergency use of unproven drugs to treat coronavirus

Review: FDA authorizes emergency use of unproven drugs to treat coronavirus

FDA will allow distribution of large quantities of two anti-malarial drugs from the federal Strategic National Stockpile to hospitals as a possible treatment for COVID-19, using the agency’s authority to permit use of unapproved medical products or unapproved uses of approved medical products during an emergency.

  • Hydroxychloroquine sulfate is approved by the Food and Drug Administration (FDA) for malaria, lupus, and rheumatoid arthritis.
  • The form of chloroquine phosphate covered by FDA’s authorization is not currently FDA-approved, but other forms are approved for malaria and extraintestinal amebiasis.
  • Based on limited in-vitro studies and clinical case data, on March 28, 2020, FDA issued an Emergency Use Authorization (EUA) for both drugs, which allows them to be prescribed and used for the treatment of COVID-19 patients even though neither has been FDA-approved for that use and both drugs have well-known serious side effects.
  • FDA based its decision on a determination that known and potential benefits of using the drugs to treat COVID-19 outweigh known and potential risks and on the absence of an adequate, approved, and available alternative.
  • FDA’s authorization allows distribution of the drugs from the nation’s Strategic National Stockpile, which will receive millions of doses from drug manufacturers.
  • Initial reports of the drugs’ effectiveness created a surge in demand for the drugs, leaving patients who use the drugs to treat other conditions such as lupus and rheumatoid arthritis unable to fill prescriptions.

The full text of FDA’s EUA statement is available here.

|2020-04-01T14:58:34-04:00March 31st, 2020|COVID-19 Literature|Comments Off on Review: FDA authorizes emergency use of unproven drugs to treat coronavirus

About the Author: Daniel Orenstein

Daniel Orenstein
Daniel G. Orenstein, JD, MPH, is Visiting Assistant Professor of Law at the Indiana University Robert H. McKinney School of Law in Indianapolis. He teaches in the areas of administrative law, public health law, and health care law and policy. His research focuses on public health law, policy, and ethics, and he was previously Deputy Director of the Network for Public Health Law Western Region, where much of his work centered on emergency preparedness and response, including resource allocation and government authority during declared emergencies, as well as vaccination policy.

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