FDA to extend COVID emergency use authorizations for ‘as long as we need,’ commissioner says

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FDA to extend COVID emergency use authorizations for ‘as long as we need,’ commissioner says
The Emergency Use Authorizations are 'independent' of the COVID-19 emergency and do not expire, Dr. Robert Califf said.



Dr. Robert Califf

Mon Feb 13, 2023
(LifeSiteNews) — The commissioner U.S. Food and Drug Administration (FDA) commissioner recently testified that the agency’s Emergency Use Authorizations (EUAs) are “independent” of the COVID-19 emergency and do not expire.

During a congressional hearing discussing “the federal response to COVID-19″ within the House Committee on Energy and Commerce, Dr. Robert Califf indicated that the federal agency will be transitioning EUAs related to COVID treatments and testing devices to standard procedure.

“Our EUAs are independent of the public health emergency, so we can keep them going as long as we need to,” Califf said. “We’ve been preparing the industry since day one to be ready for the transition. We’ll put a Federal Register Notice out about exactly how to make the transition as these products go to routine use and [are] no longer used on an emergency basis.”

The commissioner’s statement came in response to New Jersey Democrat Rep. Frank Pallone’s question about the “planning for the next phase of the federal response of this pandemic.”

In an opening statement, Califf said that the FDA has “issued EUAs or provided traditional marketing authorizations to over 2,800 medical devices for COVID-19, which is 15 times more EUAs than all other previous emergencies combined.”

Califf’s written testimony provided further details, stating that the FDA’s Center for Devices and Radiological Health (CDRH) “prioritized at-home tests since the beginning of the pandemic.”

According to Califf, the CDRH approved 30 over-the-counter at-home COVID tests made available to the public.

“Since January 2020, FDA has engaged with over 1,000 developers and authorized over 433 tests. CDRH continues to issue EUAs as appropriate for other types of devices and has taken various actions to help facilitate the availability of critical devices and supplies for health care providers and patients.”

Out of 510,000 devices that were reviewed by the agency, 1,900 are approved and “can be used for COVID-19 and certain similar diseases, including future pandemics.” The organization also released 28 “guidance documents” in an effort to expand availability of the devices.

“As we look to transition from the COVID-19 PHE [public health emergency] to normal operations, FDA has worked on guidances for transitioning devices that fall within enforcement policies issued during the COVID-19 PHE or that received EUAs to help facilitate a clear and predictable path to market for interested developers.”

Although the experimental vaccines were released to the public under emergency authorization, Califf maintained in his testimony that “vaccination is the best thing Americans can do right now to protect themselves and their families from the risk of becoming seriously ill or dying” from the virus. He added that the “proven effectiveness” of the shots has been “undercut by a constant flow of misinformation,” leading to many citizens choosing to avoid the shots.

Despite Califf’s confidence in the EUA vaccines, evidence has shown that the experimental shots can cause significant harm and may be more dangerous than contracting the COVID virus itself. Last month, U.S. Sen. Ron Johnson demanded answers from the Centers for Disease Control and Prevention (CDC) director as to why the agency said it found no “unexpected safety signals” for the vaccines. Johnson’s letter came after The Epoch Times published a report showing various adverse effects of the shots, including myocarditis, pericarditis, and cardiac arrest.

The data shows that the Vaccine Adverse Event Reporting System (VAERS) found “770 different types of adverse events” among adults over age 18. Additionally, 96 safety signals were found among vaccinated children between the ages of 12 and 17 and 66 safety signals were identified for 5- to 11-year-olds.