Connecting people with information needed to live their best possible lives.
- Emergency Use Authorizations in a Post-Emergency Worldby Kevin Homer, MD
According to the U.S. Department of Health and Human Services (HHS), the COVID-19 Public Health Emergency will expire in May, but Emergency Use Authorizations and liability protection will continue after the emergency ends.
Early in the pandemic, we were told that Emergency Use Authorizations were necessary to make unlicensed, unapproved tests, vaccines, and treatments available during an emergency. On January 31, 2020, the Health and Human Services Secretary declared the COVID-19 pandemic a public health emergency, paving the way for these products. The secretary even invoked the liability protection of the PREP Act to encourage manufacturing of countermeasures. Soon, the FDA began issuing Emergency Use Authorization letters which close with a notice that the authorization will terminate when the emergency is over.
Last month, the HHS secretary signaled his intention to end the emergency on May 11, 2023. At the same time, the secretary assured us that Emergency Use Authorizations will not be affected. According to the statement, “Existing EUAs for COVID-19 products will remain in effect under Section 564 of the Federal Food, Drug, and Cosmetic Act, and the agency may continue to issue new EUAs going forward when criteria for issuance are met.”
The Federal Food, Drug, and Cosmetic Act was amended several times by the Consolidated Appropriations Act, 2023 (see page 1339, for example). Did these amendments give FDA authority to issue EUAs without an emergency? I cannot tell you because, frankly, I get lost in the language. HHS claims its authority for EUAs in the absence of an emergency declaration dates back a decade, to the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013. Regardless, the intention is clear: EUAs will continue after the emergency is lifted.
And what will become of those PREP Act liability protections? According to HHS, these will also continue, but only for a select group of manufacturers:
Currently, the amended PREP Act declaration provides liability immunity to manufacturers, distributors, public and private organizations conducting countermeasure programs, and providers for COVID-19 countermeasure activities related to a USG [United States Government] agreement (e.g., manufacturing, distribution, or administration of the countermeasures subject to a federal contract, provider agreement, or memorandum of understanding). That coverage will not be affected by the end of the PHE. However, PREP Act liability protections for countermeasure activities that are not related to any USG agreement (e.g., products entirely in the commercial sector or solely a state or local activity) will end unless another federal, state, or local emergency declaration is in place for area where countermeasures are administered. HHS is currently reviewing whether to continue to provide this coverage going forward.
Fact Sheet: COVID-19 Public Health Emergency Transition Roadmap, February 9, 2023Manufacturers of EUA products that have an agreement with the US Government will continue to have liability protection. Other manufacturers will not. Collusion between the federal government and big businesses like this asymmetric post-emergency liability protection is the very definition of fascism.
If Emergency-Use-Authorizations without an emergency seem illogical to you, you are not alone. Even members of congress have assumed that EUAs will end with the emergency declaration.
This is not just an assault on language and logic. It is an assault on liberty.
The emergency declaration will end soon, but the emergency power-grab will continue indefinitely.
+++
“Dr. Homer is one of my heroes!”
–Dr. Peter Navarro, October 16, 2021
23 replies on “Better Pathology”
So pleased to see another voice of reason.
THANKS for your courage to step up and speak the truth which is so rare today. Your appearance on warroom was appreciated and great to see. Nice job there also. And finally, your summation of “How We Got Here” is one of the most accurate and succinct explanations of this whole covid devastation I’ve seen or heard. Again, thanks!
Absolutely the best simple language explanation to identify the corona virus mandates.Dr. Homer. Thank you.. I will add the mandates are akin to an age old attempt to domesticate animals, not unlike the use of a cattle prod to control animals.. This is clearly a predator / prey relationship that dates back many thousands of years to the agriculture revolution. More recently, they, the elites, expressed their fear of the pitch fork rebellion. There only response was to control us.
Great Warroom appearance! So glad I found you. Always looking for another voice of reason amidst the hysteria most of our nation has been consumed by… Sadly. Thanks for your science-based content. Thank for standing for Freedom!!
I have shared your blog with 3 people now who just wanted to be more educated your amazing at what you do and explaining it to us in a way we understand. Thank you
Thank you for standing for true science and public health.
For those appreciating this fine website please consider my book Pandemic Blunder that is totally in tune with this doctor:
https://www.amazon.com/Pandemic-Blunder-Public-Blocked-Treatment/dp/197723822X/ref=nav_signin?dchild=1&keywords=Pandemic+Blunder&qid=1612289098&sr=8-1&&
I’m proud of you Dr. Homer!
Thank you Dr Homer for all your research. So great to see real science and common sense here.
Hope you and your family are well.
Dr Homer, I think one thing you should be complimented on is how much quality you manage to include while using very few words. There is lots of “meat on the bone” when you post. Thanks!
Thank you Dr Horner…I saw you in WarRoom today…God Bless you man…..I am a Medical Technologist with an MBA working in Laboratories my whole career. I RETIRED from Kaiser Permanente….so happy to hear from STRONG PATHOLOGISTS such as yourself.
The truth here! How refreshing!!
Dr Homer, your Nov 2 post is brilliant, in concept and in execution, in what it says and in what it doesn’t say. I pray that it has an influence on our government authorities.
Much of the public may not yet know this. But missing from the new CDC definition of vaccine as of September 1, 2021 are these key phrases: “protecting the person from that disease” and “to produce immunity.” The new vaccine definition should reduce public confidence in current COVID vaccines. In fact, these changes reflect what is now known about the limitations of these vaccines. Fully vaccinated people can still get COVID disease and really do not have long lasting effective immunity to it.
Bold New Book PANDEMIC BLUNDER – FAUCI AND PUBLIC HEALTH BLOCKED EARLY HOME COVID TREATMENT by Joel S. Hirschhorn
A huge amount of data and information not covered by mainstream media are in Pandemic Blunder that tells the story of how over 600,000 Americans have died from COVID-19 unnecessarily because the government has blocked early home/outpatient treatment and prevention. With over 600,000 COVID American deaths, learning about safe and effective treatment is more important than ever.
About the Book:Pandemic Blunder contains considerable medical information and data to support a number of proven safe, cheap generic medicines and protocols that knock out the coronavirus when given early. Read about the pioneering, courageous doctors who have been using innovative approaches to prevent their COVID patients from needing hospital care and facing death. The book includes many expert opinions and Real World Evidence from doctors that show 70 to 80 percent of COVID deaths could have been prevented—and still can be. Don’t be victimized by disinformation and propaganda. Learn how corrupt forces are aiming to make billions of dollars from expensive medicines and vaccines, and how hundreds of thousands of deaths could have—and should have—been prevented! Detailed information is given to help people protect their lives by using simple prevention protocols, an alternative to vaccines.
https://www.amazon.com/Pandemic-Blunder-Public-Blocked-Treatment/dp/197723822X/ref=nav_signin?dchild=1&keywords=Pandemic+Blunder&qid=1612289098&sr=8-1&&
I heard on the news today that since the Delta came from India and Omicron from S. Africa, both very low vaccinated populations, that this supports variants coming form the unvaccinated?
Worth reading:special report on Omicron variant
https://joelshirschhorn.substack.com/p/special-report-understanding-new
Consider becoming a subscriber; no charges
Here are two articles you will appreciate:
https://joelshirschhorn.substack.com/p/special-information-for-subscribers
https://joelshirschhorn.substack.com/p/deathbed-use-of-ivermectin-to-save
Become a subscriber to my Pandemic Blunder Newsletter
joelshirschhorn.substack.com
How have lives been lost during pandemic? Read this and find out:
https://joelshirschhorn.substack.com/p/so-many-lives-lost?justPublished=true
Even worse than so much taxpayer money feeding the wealth of drug companies making billions from COVID vaccines is the scandal about deadly batches of vaccines because our government has not ensured quality manufacturing of vaccines; read this important new article:
https://joelshirschhorn.substack.com/p/priority-article-biggest-covid-vaccine
Can you trust hospital data?
https://joelshirschhorn.substack.com/p/hospital-data-and-care-cannot-be
Here is a great article showing cases where autopsies have proven COVID vaccines kill people:
https://joelshirschhorn.substack.com/p/proven-covid-vaccine-induced-deaths?utm_source=url
Thank you Dr. Homer for your diligence in keeping us safe by letting us know of items the media fails to mention.
Dr. Homer,
Thank you for this informative blog. The public needs REAL information. I appreciate your candid honesty.