HHS Secretary Becerra Issues 564 Declaration to Expand the Availability of Testing for Monkeypox

Today, U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra signed a declaration under section 564 of the Federal Food, Drug, and Cosmetic Act to allow the U.S. Food and Drug Administration (FDA) Commissioner to issue emergency use authorizations for in vitro diagnostics to expand the availability of tests for monkeypox. This follows the August 4 declaration of a public health emergency for monkeypox.

“Last month, I declared monkeypox to be a public health emergency to unlock additional tools to signal to the American people that we are using every resource at our disposal to end this outbreak,” said Secretary Becerra. “Today’s action is an important step forward in our monkeypox response by allowing the FDA to facilitate the development of more validated monkeypox tests and expand access to testing.”

Today’s action is the latest step the Biden-Harris Administration has taken to respond to the ongoing spread of the monkeypox virus in the United States. Within two days of the first confirmed case in the U.S., the Administration began making vaccines and treatments available to states and other jurisdictions for free.

Through partnerships with the country’s largest commercial laboratories, testing capacity has increased rapidly to more than 80,000 per week as HHS continues to communicate important public health messages and raise awareness with key stakeholders.

To date, HHS has made nearly 1.1 million vials of the JYNNEOS vaccine available to order and, so far, has shipped more than 772,000 vials.