I remember the Brook Jackson whistleblower story. That is just standard issue incompetence. The argument that trials are not important for EUA’s is a terrible precedent, but judges don’t know anything about pharmaceuticals. This does explain why the FDA thinks they can get away with making such a large process change without threats of criminal liability, though.
I remember the Brook Jackson whistleblower story. That is just standard issue incompetence. The argument that trials are not important for EUA’s is a terrible precedent, but judges don’t know anything about pharmaceuticals. This does explain why the FDA thinks they can get away with making such a large process change without threats of criminal liability, though.
Excerpted from Pfizer's argument to the judge in that case:
The [contract’s Statement of Work] describes a ‘large scale vaccine manufacturing demonstration’ that imposes no requirements relating to Good Clinical Practices (‘GCP’) or related FDA regulations…
Literally zero standards. And this is mere incompetence? Their contract exempted them from manufacturing standards meaning they could literally inject you with liquified sewage. That was an accident? An oversight? It was written in the contract!!
I remember the Brook Jackson whistleblower story. That is just standard issue incompetence. The argument that trials are not important for EUA’s is a terrible precedent, but judges don’t know anything about pharmaceuticals. This does explain why the FDA thinks they can get away with making such a large process change without threats of criminal liability, though.
Quoted from here: https://bailiwicknews.substack.com/p/key-quotes-from-pfizers-april-22
Excerpted from Pfizer's argument to the judge in that case:
The [contract’s Statement of Work] describes a ‘large scale vaccine manufacturing demonstration’ that imposes no requirements relating to Good Clinical Practices (‘GCP’) or related FDA regulations…
Literally zero standards. And this is mere incompetence? Their contract exempted them from manufacturing standards meaning they could literally inject you with liquified sewage. That was an accident? An oversight? It was written in the contract!!