manager who contacted FDA in Sept'20 to report violations of clinical trial and patient safety procedures at two of the Texas sites where Ventavia for Pfizer were recruiting people to administer Pfizer’s products throughout Summer '20
the clinics & reported her whistleblower contact to Pfizer.
Pfizer sent attorney Barnes on Jackson in Oct'20.
In Jan'21 Jackson filed a federal complaint under the False Claims Act at District Court, Eastern Texas. (1:21-cv-00008-MJT)
“..the agreement was not a standard federal procurement contract, but rather a ‘prototype’ agreement executed pursuant to 10 U.S.C. § 2371b[.]…"
a ‘large scale vaccine manufacturing demonstration’ that imposes no requirements relating to Good Clinical Practices (‘GCP’) or related FDA regulations.”
The whole point is that under the EUA GCP regulations aren't required.
g…In the case of the Ventavia Research Group for site 1085, a mere 1.4% of Subjects are accounted for. Since Pfizer is under court order to release complete lists, what on earth is going on here?"
he complete lists of Subjects, then where did the data relating to the hundreds of other Subjects/participants go?"
that 97% of the patients are missing from the Clinical Record Forms (CRFs) files released in the first document dump. This is the clincher. So many people don't understand what it means but you have to."
l record forms (CRFs) for each of the four sites' forms released as part of the court orders [in Public Health and Medical Professionals for Transparency v. FDA]."
ecause that is the number in the recruitment log.
They are NOT in a later dump because the court order was for the four biggest sites CRFs to be released first, which they did."
thorization “countermeasures,” under the Project Bioshield Act of 2004 amendments to the 1938 Federal Food, Drug and Cosmetics Act and the 1944 Public Health Service Act."
ey are by Congress's legal definition, not part of any “clinical investigation,” despite the fact that the Phase 3 clinical trials will not be finished for two years at the earliest."
uct is the subject of an authorization under this section, the use of such product within the scope of the authorization shall not be considered to constitute a clinical investigation.."
r 360j(g) of this title or any other provision of this chapter or section 351 of the Public Health Service Act [42 U.S.C. 262].”
ion under this section, the use of such product within the scope of the authorization shall not be considered to constitute a clinical investigation for purposes of section 355(i)”