HHS Accepts Donations Of Medicine To Strategic National Stockpile As Possible Treatments For COVID-19 Patients Covid-19 Treatments

FDA issues danger use authorization for donated hydroxychloroquine sulfate, chloroquine phosphate

The U.S. Department of Health and Human Services (HHS) today 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 feasible use within treating patients hospitalized with or for use within 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.

“President Trump is taking every feasible stride to protect Americans from the coronavirus and provide them with hope,” said HHS Secretary Alex Azar. “Scientists within 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 within 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.”

HHS’ Office of the Assistant Secretary for Preparedness and Response () worked with colleagues in HHS, the companies, the Department of State, and the Department of Homeland Security to secure the donated shipments. Given the importance of perception the efficacy of these medications for the medical care 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 system clinical trials.

The U.S. Food and Drug Administration () to BARDA to allow hydroxychloroquine sulfate and chloroquine phosphate products donated to the Strategic National Stockpile (SNS) to be present 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.

The EUA requires that fact sheets that provide important information about using chloroquine phosphate and hydroxychloroquine sulfate within treating COVID-19 be present made available to health care providers and patients, including the famous risks and drug interactions.

The SNS, managed by ASPR, will work with the Federal Emergency Management Agency (FEMA) to ship donated doses to states. The SNS does not regularly stock either drug.

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 within laboratory studies against coronaviruses, including SARS-CoV-2 (the virus that causes COVID-19). Anecdotal reports suggest that these drugs may offer some benefit within the medical care of hospitalized COVID-19 patients. Clinical trials are needed to provide technological evidence that these treatments are effective.

When the Secretary of Health and Human Services declares that issuance of an EUA is appropriate, the FDA has the regulatory danger use authority to facilitate access to unapproved medical countermeasures or unapproved uses of approved medical countermeasures needed to make or get ready for and respond to chemical, biological, radiological and nuclear threats.

An  EUA may be present issued if the FDA determines that, with other criteria, the famous and potential benefits of the product, when used to diagnose, prevent, or treat the identified disease or condition, outweigh the famous 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.

The FDA has issued an EUA for diagnostics, for several other medical devices such as respiratory devices and a system for decontaminating them to allow for their reuse, and ventilators and ventilator equipment for the COVID-19 response. This is the first EUA for a drug related to the COVID-19 response.

Sandoz and Bayer are the latest companies .

Use of the donated medications is expected to help ease supply pressures for the drug, and the FDA is and working with manufacturers of chloroquine and hydroxychloroquine to increase production to guarantee these drugs and remain available for patients dependent on them for medical care of malaria, lupus and rheumatoid arthritis. Some states and retail pharmacies and have pleased action to preserve the supply of these and other drugs for these patients.

In addition to accepting and distributing the donated medicines, HHS is funding clinical trials of two drugs, Kevzara (sarilumab) and remdesivir, and is supporting the earlier increase of multiple potential therapeutic treatments, vaccines, and diagnostic tests for COVID-19.

HHS continues to look for partners for COVID-19 medical countermeasures, and offers to submit proposals for potential products or technologies.

About HHS, ASPR, and FDA

HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances within medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats, and in ASPR, the Strategic National Stockpile represents the nation’s largest stockpile of life-saving pharmaceuticals and medical supplies for use within supplementing state and local supplies within a public health emergency. The FDA 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 and is guilty 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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