More Pfizer Follies.....
“Pfizer Moves to Dismiss Lawsuit From COVID-19 Vaccine Trial, Citing ‘Prototype’ Agreement.”
The gist is that whistleblower Brook Jackson sued Pfizer last year alleging that the vaccine maker violated federal laws governing procurement of new drugs and clinical trial regulations. But Pfizer just filed a motion to dismiss Brook’s lawsuit, arguing that those laws and regulations don’t apply to its vaccine contract with the U.S. Department of Defense, because its agreement was executed under a special provision for “prototype drugs,” allowing contractors to skirt many of the rules and laws that typically apply to normal drug development contracts.
In the “Background” section of its Motion to Dismiss, here’s exactly what Pfizer argued:
Because of pandemic-related exigencies, the agreement was not a standard federal procurement contract, but rather a ‘prototype’ agreement executed pursuant to 10 U.S.C. § 2371b[.] … The [contract’s Statement of Work] describes a ‘large scale vaccine manufacturing demonstration’ that imposes no requirements relating to Good Clinical Practices (‘GCP&rsquo or related FDA regulations.
So there you have it. It wasn’t a “rushed experimental drug.” According to PFIZER, it was an “exigency-driven prototype manufacturing demonstration not subject to good clinical practices and related FDA regulations.” It’s totally different from an experiment. This was a “demonstration.”
It took me a while to stop laughing. I’m old enough to remember when calling the jabs “experimental drugs” could get you thrown in Facebook jail. Now PFIZER is shirking liability for its shoddy trials by calling its own drug a “prototype” and a “demonstration.” That would’ve made for a good marketing slogan, right? “Our drug isn’t experimental, it’s a prototype!”
The bottom line is a prototype isn’t something you give to consumers. It’s a mock up, a test. This argument is a joke. It might work, but it’s a joke, a joke they played on all of us.
Pfizer said a lot of other dumb stuff in its motion. For those of you with legal interests, here’s a downloadable copy of the Motion to Dismiss. Even non-lawyers can understand the introductory section. - Jeff Childers 'Coffee and Covid'
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