FDA Issues Emergency Authorization of Hydroxychloroquine Amid Coronavirus Pandemic

We want to keep you updated on the latest news impacting access to hydroxychloroquine (Plauqenil) and chloroquine for people with lupus amid the coronavirus pandemic.

Late yesterday, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to allow hydroxychloroquine and chloroquine for coronavirus COVID-19 treatment.

The U.S. Department of Health and Human Services (HHS) said in a statement that the authorization would allow for 30 million doses of hydroxychloroquine donated by Sandoz, the Novartis generics and biosimilars division, and one million doses of chloroquine donated by Bayer Pharmaceuticals to be donated to the HHS’ Strategic National Stockpile (SNS).

The donated doses of hydroxychloroquine 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 or feasible,” said HHS in its statement.

The FDA’s authorization does not mean hydroxychloroquine and chloroquine are specifically approved as safe and effective for use for COVID-19, but instead that they are available for use for COVID-19.

Moreover, the HHS said that “use of the donated medications is expected to help ease supply pressures for the drug, and the FDA is also working with manufacturers of chloroquine and hydroxychloroquine to increase production to ensure these drugs also remain available for patients dependent on them for treatment of malaria, lupus and rheumatoid arthritis.”

While it is encouraging for the lupus community that the HHS’ statement indicates that it will help ensure people with lupus have access to these medications, it is still unknown at this point as to exactly how the medications will get distributed and the overall impact of availability of the drugs for those who need the drugs now.  

The Lupus Foundation of America has been talking with key stakeholders and companies involved in the drug supply chain, including state boards of pharmacy, federal government and agencies, and other important stakeholders – and our voices are clearly being heard. The actions from the FDA and HHS are certainly a step in the right direction, but our work is far from over.  

Stay tuned for more updates, and please continue to visit lupus.org/coronavirus to access resources and other important information involving COVID-19 and lupus.