Public Health Emergency - Leading a Nation Prepared
On November 9, Eli Lilly and Company received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the investigational monoclonal antibody treatment bamlanivimab. The EUA allows healthcare providers to administer bamlanivimab to non-hospitalized patients with confirmed COVID-19 who are experiencing mild to moderate symptoms and are at high-risk for severe symptoms and hospitalization. In alignment with the terms of the EUA for bamlanivimab, the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response (HHS/ASPR) will oversee allocation of the drug and coordinate its distribution.
HHS is sponsoring the development of a number of therapeutic products that have been granted
Emergency Use Authorization by the FDA and/or are being made available under FDA’s
expanded access program for the treatment of COVID-19.
Learn more about other COVID-19 therapeutics, including:
HHS/ASPR is committed to the equitable and efficient distribution of bamlanivimab with the goal of reaching as many patients as possible, no matter where in the country they live and regardless of their income. HHS is coordinating with Eli Lilly and Company, AmerisourceBergen, (the distributor of the drug), state and territorial health departments, and national healthcare and medical organizations and associations to get bamlanivimab into the hands of healthcare providers quickly, with a focus on areas of the country hardest hit by the pandemic.
In general, a state/territory’s percentage of the country’s total number of confirmed COVID-19 patients and the total number of confirmed hospitalized patients during a 7-day reporting period will equal that state/territory’s percentage of available bamlanivimab for a given distribution week. Once allocation amounts are determined, HHS-ASPR will notify state/territorial health departments of their bamlanivimab allocations. State/territorial health departments, not the federal government, then determine how much bamlanivimab each health care facility within their respective jurisdictions can receive based on the state/territory’s total allocation. Health care facilities identified by their respective state/territorial health department to receive an allocation of bamlanivimab will coordinate shipping directly with the distributor, AmerisourceBergen.
In addition to allocations to states and territories, bamlanivimab is being allocated to the Department of Defense, the Veterans Health Administration, and the Indian Health Service for distribution within those healthcare systems.
Bamlanivimab is allocated by the federal government to states, territories, and federal entities on a weekly basis. Allocations will be made in two phases. During Phase 1, states/territories will allocate Bamlanivimab to hospitals and hospital-affiliated locations. Upon further assessment of drug administration requirements, Phase 2 of allocations will include expanded distribution to additional outpatient facilities.
To find out how much bamlanivimab has been allocated to specific states, territories, and identified agencies, see the bamlanivimab
allocation dashboard. This dashboard will be updated each distribution week until the FDA either approves the drug or issues a revised EUA indicating U.S. government involvement in the allocation and distribution process is no longer required. This may occur when the supply of the product meets the demand from the commercial marketplace.
In certain types of emergencies, the HHS Secretary may issue a determination and declaration under the Food Drug and Cosmetic Act that permits the FDA to issue EUAs to facilitate access to medical countermeasures (drugs, biologics, vaccines, and devices) that can be used to diagnose, treat, or prevent a serious disease or condition in a public health emergency.
Products authorized for use in this way may not be approved by the FDA for any use, or they may be approved for other uses but not for the emergency use. The FDA decides whether the use of the product is likely to be more helpful than harmful for the emergency use; i.e., the agency determines that the known and potential benefits of the medical products for their intended uses outweigh their known and potential risks.
This authorization is reserved for emergency situations and is not the same as FDA approval or licensure.
Below is more information about the EUA for bamlanivimab.
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