FDA Reveals ‘Impact’ After White House Announces End to COVID Emergency

The U.S. Food and Drug Administration in White Oak, Md., on July 20, 2020. Sarah Silbiger/Getty Images

The U.S. Food and Drug Administration (FDA) on Tuesday said that a recent announcement from the Biden administration will not impact the agency’s ability to issue emergency use authorizations for certain COVID-19 treatments and vaccines.

“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 FDA said in a Jan. 31 update after the Biden administration signaled the emergency would end in May. “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 agency issued that same statement to a CNBC reporter on Tuesday when asked about how emergency use authorizations, or EUAs, will be handled once the public health emergency ends. The Epoch Times has contacted the FDA for comment.

Every COVID-19 vaccine currently approved by the FDA was initially given emergency use authorizations. That includes the ones made by Pfizer, Johnson & Johnson, Moderna, and Novavax.

Meanwhile, commonly used COVID-19 treatments, including Pfizer’s Paxlovid, were also handed emergency use authorizations by the FDA.

The FDA added Tuesday that it will issue a Federal Register notice on how the decision to end the emergency will impact the agency’s “COVID-19-related guidances and which of those guidances it is temporarily extending or letting expire.” It added, “The FDA remains committed to providing notice and information to all impacted stakeholders to ensure a smooth transition.”

An emergency use authorization declaration is separate and not dependent on Health and Human Services’ public health emergency declarations under section 319 of the 1944 Public Health Service Act, the FDA noted.

“If an EUA declaration is terminated, notice of termination will be published in the Federal Register,” the agency wrote. “Before an EUA declaration is terminated, the Secretary will issue a Federal Register notice providing advanced notice to the public that the EUA declaration is being terminated. This starts the transition, which must be of a reasonable period to allow for proper dispositioning.”

Emergency Ending May 11

The announcement came hours after the White House on late Monday told Congress it plans on ending the emergency on May 11, which would restructure the government’s response to the pandemic. That includes how certain public benefits like Medicaid are given out, and it would also potentially shift the cost of COVID-19 vaccines from the federal government to private insurers, or to individuals.

In early 2020 under the Trump administration, the first public health emergency was declared over COVID-19. It allowed the federal government to bear the costs of COVID-19 vaccines, treatments, and testing.

“At present, the Administration’s plan is to extend the emergency declarations to May 11, and then end both emergencies on that date,” the Office of Management and Budget said in a statement (pdf). “This wind-down would align with the Administration’s previous commitments to give at least 60 days’ notice prior to termination of the PHE.”

“To be clear, continuation of these emergency declarations until May 11 does not impose any restriction at all on individual conduct with regard to COVID-19,” the administration added. “They do not impose mask mandates or vaccine mandates. They do not restrict school or business operations. They do not require the use of any medicines or tests in response to cases of COVID-19.”

Before the statement, House Republicans in recent days proposed at least two bills to end the emergency. The White House’s Monday statement said the Biden administration will not support those measures because that ending those declarations would create “highly significant impacts on our nation’s health system and government operations.”

“The Administration supports an orderly, predictable wind-down of Title 42, with sufficient time to put alternative policies in place,” the Office of Management and Budget said, referring to the Trump-era immigration rule that allowed for the expelling of certain illegal immigrants and asylum-seekers.

Last year, a bipartisan group of senators voted to end the COVID-19 emergency, although the White House at the time signaled that President Joe Biden would veto the bill if it cleared the House. With Republicans in control of the lower chamber, it raised the chances of such a measure being passed in Congress.

On Tuesday, some Republican lawmakers were critical of the White House’s decision and said it was only announced due to GOP pressure.

“Republicans already getting results. This week we are voting to end the COVID emergency. In response, Biden announces HE IS going to end the COVID-19 emergency declarations. Now that Biden is trying to avoid embarrassment, how will democrats vote? What about vax mandates?” wrote Rep. Thomas Massie (R-Ky.), a frequent critic of vaccine mandates.