So long as the shots are classified as Emergency Use Authorization “countermeasures,” under the Project Bioshield Act of 2004 (amendments to 1944 Public Health Service Act and 1938 Federal Food, Drug and Cosmetics Act), they are by legal definition not part of any “clinical investigation,” despite the fact that the Phase 3 clinical trial…
So long as the shots are classified as Emergency Use Authorization “countermeasures,” under the Project Bioshield Act of 2004 (amendments to 1944 Public Health Service Act and 1938 Federal Food, Drug and Cosmetics Act), they are by legal definition not part of any “clinical investigation,” despite the fact that the Phase 3 clinical trials will not be finished for quite awhile.
See 21 USC 360bbb-3(k)
Found that two days ago while reading the statutes.
It’s relevant to the legal arguments about how employers and governments can ‘mandate’ shots, without running afoul of Nuremberg Code and 45 CFR 46.116 provisions for informed consent for experimental subjects without duress or coercion.
Combined with a Slip Opinion issued by a Deputy Attorney General July 6, 2021, and the Bridges v. Houston Methodist Hospital June 12, 2021 ruling from Southern District of Texas, it’s legislative, regulatory and judicial nullification of informed consent principles for US citizens.
Bridges case is currently on appeal in Fifth Circuit - plaintiff brief filed in November 2021, hospital brief filed in late January 2022.
The judge in Bridges set several terrible precedents on June 12, 2021, including that "the hospital's employees are not participants in a human trial. They are licensed doctors, nurses, medical technicians and staff members." The implication being, nurses and doctors are not human, and therefore can't be human subjects of medical experiments. And the judge said the vaxxes can't be construed as violating Nuremberg, because the hospital is a private employer, not a government.
Deputy AG Dawn Johnsen in her July 6, 2021 "slip opinion," then cited the Bridges ruling as dispositive, to conclude that any entity can mandate any producted granted EUA status by HHS/FDA.
Looks like Title 21 is regulations specific to FDA division of HHS, under heading of "Food and Drugs," and Title 45 is regulations related to Health and Human Services as a whole, under heading of "Public Welfare." Not sure how they relate to each other.
So long as the shots are classified as Emergency Use Authorization “countermeasures,” under the Project Bioshield Act of 2004 (amendments to 1944 Public Health Service Act and 1938 Federal Food, Drug and Cosmetics Act), they are by legal definition not part of any “clinical investigation,” despite the fact that the Phase 3 clinical trials will not be finished for quite awhile.
See 21 USC 360bbb-3(k)
Found that two days ago while reading the statutes.
It’s relevant to the legal arguments about how employers and governments can ‘mandate’ shots, without running afoul of Nuremberg Code and 45 CFR 46.116 provisions for informed consent for experimental subjects without duress or coercion.
Combined with a Slip Opinion issued by a Deputy Attorney General July 6, 2021, and the Bridges v. Houston Methodist Hospital June 12, 2021 ruling from Southern District of Texas, it’s legislative, regulatory and judicial nullification of informed consent principles for US citizens.
Bridges case is currently on appeal in Fifth Circuit - plaintiff brief filed in November 2021, hospital brief filed in late January 2022.
The judge in Bridges set several terrible precedents on June 12, 2021, including that "the hospital's employees are not participants in a human trial. They are licensed doctors, nurses, medical technicians and staff members." The implication being, nurses and doctors are not human, and therefore can't be human subjects of medical experiments. And the judge said the vaxxes can't be construed as violating Nuremberg, because the hospital is a private employer, not a government.
Deputy AG Dawn Johnsen in her July 6, 2021 "slip opinion," then cited the Bridges ruling as dispositive, to conclude that any entity can mandate any producted granted EUA status by HHS/FDA.
Very informative. Thank you!
Looks like Title 21 is regulations specific to FDA division of HHS, under heading of "Food and Drugs," and Title 45 is regulations related to Health and Human Services as a whole, under heading of "Public Welfare." Not sure how they relate to each other.