EUAs: In Name Only
To my surprise the Emergency Use Authorizations (EUA) for Covid related products will remain unaffected by this change. Wait, the resulting authorizations of a Public Health Emergency have no tie.
On April 10th, 2023 President Biden signed H.J.Res.7 into law, ending the Public Health Emergency (PHE) that has been in effect since March 2020.
My guess is that the average person would have no idea that a Public Health Emergency just ended. In my opinion this discredits the concept if you’re going to apply it willy-nilly.
To my surprise the Emergency Use Authorizations (EUA) for Covid related products will remain unaffected by this change.
Wait, the resulting authorizations of a Public Health Emergency have no tie to the actual PHE?
That’d be like calling the fire department because your house is on fire, then months later find they moved in.
How is this the case?
The FDA is nice enough to address these concerns, here.
“Importantly, the ending of the PHE declared by HHS under the PHS Act will not impact FDA’s ability to authorize devices (including tests), treatments or vaccines for emergency use. 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.”
As well as.
“Under section 564(f)(2) of the FD&C Act, authorization of an unapproved product continues to be effective, even after termination of the EUA declaration or revocation of the EUA, to provide for continued use with respect to a patient to whom it was administered while the declaration remained effective (to the extent found necessary by the patient’s physician).”
What I take this to mean is, even after authorization is gone, doctors can administer these products as long as their patients want them.
Now how do we get from authorizing products under the pretense of an emergency to you can have it for as long as you want.
You can read the slipperiness of the language yourself here.
“With respect to the emergency use of an unapproved product, the Secretary, to the extent practicable given the applicable circumstances described in subsection (b)(1), shall, for a person who carries out any activity for which the authorization is issued, establish such conditions on an authorization under this section as the Secretary finds necessary or appropriate to protect the public health, including the following:
(i) Appropriate conditions designed to ensure that health care professionals administering the product are informed-
(I) that the Secretary has authorized the emergency use of the product;
(II) of the significant known and potential benefits and risks of the emergency use of the product, and of the extent to which such benefits and risks are unknown; and
(III) of the alternatives to the product that are available, and of their benefits and risks.”
This comes off as circular logic to me. Essentially we’re gunna keep doing what we did because at one point it was done.
Never mind the unknown risks or need for such things disappearing entirely.
We all suffered through Covid, mistakes were made and millions died, but littered throughout history are instances of emergencies being used to restrict freedom, and if we’re not careful we’ll realize it already happened.