In a press release on March 29, 2020, the HHS announced that they accepted 30 million doses of hydroxychloroquine sulfate donated by Sandoz and 1 million doses of chloroquine phosphate donated by Bayer Pharmaceuticals, for the possible treatment of COVID-19.
“Scientists in America and around the world have identified multiple potential therapeutics for COVID-19, including chloroquine and hydroxychloroquine,” said Alex Azar, HHS Secretary, in the press release. “We’ll continue working around the clock to get American patients access to therapeutics that may help them battle COVID-19, while building the evidence to evaluate which options are effective.”
The donations came after the US Food and Drug Administration (FDA) issued the first Emergency Use Authorization (EUA) for a drug related to the COVID-19 response to the Biomedical Advanced Research and Development Authority.
The EUA allows hydroxychloroquine sulfate and chloroquine phosphate to be donated to the Strategic National Stockpile (SNS) to then be distributed by physicians to teenage and adult patients with COVID-19 or for use in clinical trials.
The SNS will work with the Federal Emergency Management Agency (FEMA) to ship donated doses to states.
Hydroxychloroquine sulfate and chloroquine phosphate are approved to treat other conditions (eg, malaria, lupus), and although there are currently no FDA-approved treatments for COVID-19, both drugs have shown activity in studies against COVID-19.
The EUA does require that fact sheets that provide important information about using chloroquine phosphate and hydroxychloroquine sulfate in treating COVID-19 be made available to health care providers and patients, including the known risks and drug interactions.
The donated doses are expected to help ease supply pressures for hydroxychloroquine sulfate and chloroquine phosphate. The FDA is also working with manufacturers of both drugs to increase production, so patients who are already dependent on them to treat malaria, lupus, and rheumatoid arthritis can still receive it.
Sandoz, Bayer Pharmaceuticals, and other companies are encouraged to donate more doses. Interested companies can contact FEMA directly by emailing email@example.com or through their website.