WASHINGTON DC - The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to allow hydroxychloroquine sulfate and chloroquine phosphate products donated to the Strategic National Stockpile(SNS) to be distributed and used for certain hospitalized patients with COVID-19. These drugs will be distributed from the SNS to states for doctors to prescribe to adolescent and adult patients hospitalized with COVID-19, as appropriate, when a clinical trial is not available or feasible.
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The EUA requires 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 SNS, managed by ASPR, will work with the Federal Emergency Management Agency (FEMA) to ship donated doses to states.
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On March 29 the U.S. Department of Health and Human Services (HHS) accepted 30 million doses of hydroxychloroquine sulfate donated by Sandoz, the Novartis generics and biosimilars division, and one million doses of chloroquine phosphate donated by Bayer Pharmaceuticals, for possible use in treating patients hospitalized with COVID-19 or for use in clinical trials. These and other companies may donate additional doses, and companies have ramped up production to provide additional supplies of the medication to the commercial market.
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“President Trump is taking every possible step to protect Americans from the coronavirus and provide them with hope,” said HHS Secretary Alex Azar. “Scientists in America and around the world have identified multiple potential therapeutics for COVID-19, including chloroquine and hydroxychloroquine. The President’s bold leadership and the hard work of FDA and HHS’s Assistant Secretary for Preparedness and Response have succeeded in securing this large donation of medicine. 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.”
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HHS’ Office of the Assistant Secretary for Preparedness and Response (ASPR) worked with colleagues within HHS, the companies, the Department of State, and the Department of Homeland Security to secure the donated shipments. Given the importance of understanding the efficacy of these medications for the treatment and prevention of COVID-19, federal agencies, such as the National Institutes of Health and ASPR’s Biomedical Advanced Research and Development Authority (BARDA), are working together to plan clinical trials.
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Hydroxychloroquine sulfate and chloroquine phosphate are oral prescription drugs approved to treat malaria and other diseases. Although there are no currently approved treatments for COVID-19, both drugs have shown activity in laboratory studies against coronaviruses, including SARS-CoV-2 (the virus that causes COVID-19). Anecdotal reports suggest that these drugs may offer some benefit in the treatment of hospitalized COVID-19 patients. Clinical trials are needed to provide scientific evidence that these treatments are effective.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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