FDA Policy/General

Biden Administration Ending Public Health Emergency 5/11

The Biden Administration has announced that it will end the current Covid-19 public health emergency (PHE) declaration and national emergency declaration, which were declared in 2020, on 5/11. FDA says a future Federal Register notice will be published on how the decision to end the PHE will affect Covid-19-related guidances and which of these are being temporarily extended and which will expire, according to an agency update notice.

“Importantly, the ending of the public health emergency declared by HHS under the Public Health Service Act will not impact FDA’s ability to authorize devices (including tests), treatments or vaccines for emergency use,” the notice says. “Existing emergency use authorizations (EUAs) for products will remain in effect and the agency may continue to issue new EUAs going forward when criteria for issuance are met… The FDA remains committed to providing notice and information to all impacted stakeholders to ensure a smooth transition.”

The Administration announced the decision to end the PHE in a 1/30 Statement of Administration Policy that objected to two recent House bills that sought to end the PHE much sooner than 5/11. It said that any abrupt end to the PHE would cause tens of millions of Americans to abruptly lose Medicaid coverage that was expanded under the PHE. The policy statement also complained that abruptly ending the PHE would lift Title 42 immediately, and result in a substantial additional inflow of migrants at the Southwest border. “The number of migrants crossing the border has been cut in half, approximately, since the Administration put in place a plan in early January to deter irregular migration from Venezuela, Cuba, Nicaragua, and Haiti,” it says.

For more information about what happens to EUAs when the PHE ends, visit FDA’s Web page for answers to frequently asked questions.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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