The Emergency Use Authorization (EUA) provision in the Federal Food, Drug, and Cosmetic Act allows the Food and Drug Administration (FDA) to facilitate the availability and use of medical countermeasures, including vaccines and treatments, during public health emergencies, such as pandemics or bioterrorism threats. The EUA does not, however, contain provisions requiring data collection, monitoring, advertising of the adverse event reporting system, or open data.
During the SARS-CoV-2 public health emergency, federal agencies failed in all these areas. As a result, despite administering millions of vaccine doses over the course of years, the government remains far from achieving the regulatory oversight required for approving such medical interventions under normal, non-emergency conditions.
Congress should set minimum standards and requirements to ensure agencies fulfill their regulatory responsibilities and meet the challenges of the next public health emergency.
Federal Food, Drug, and Cosmetic Act
Authorization for medical products for use in emergencies
21 U.S. Code § 360bbb–3
I absolutely DISAGREE with this policy proposal. This puts more power in the hands of state agencies to potentially “regulate” the American People via forced monitoring and God-knows what else they come up with under the excuse of “public health service”. We have already seen what the government did with hiding the statistics and data from the American People with VAERS – making mandatory systems to collect data does not help the American People one bit when the govt actively hides the data.
The only thing that will happen, is that government agencies will have greater authority to place controls and monitoring and over the People under the guise of ‘data collection’, and will give broader authority to do it even under “non-emergency” situations. Notice how it is mentioned that this kind of added govt control is needed just in time for the NEXT “plandemic”.
Guess what was hidden inside the 1500 page grotesque monstrosity of a continuing resolution that Congress tried and failed to pass. The disgusting garbage was an attempt to resurrect COVID-era restrictions once again on the American People.
I’m sorry, but this policy proposal looks like it was crafted by a Congressperson or a regulator, and made to look like it is coming from the grass-roots level. It fits hand-in-glove with efforts made just in the past few weeks by our rogue politicians. I am totally against it – the only thing I can see it accomplishing after getting in the hands of the government, is a massive screw-tightening on the American People. There are vitrually no benefits to the American People (because the data will be falsified and/or hidden from the people, like the VAERS data was), and the open-ended repurcussions could be massive (like busting down your front door in order to “collect public health data”) . If anything, we should be trying to DO AWAY WITH “Emergency Use Authorization” AND the FDA AND CDC while we are at it. We don’t need to help the govt act more tyrannical that it already has demonstrated itself to be. No offense to the poster. BAD IDEA!!! My two cents on it.x
My two cents on it.x