How they killed informed consent after 75 years of honoring Holocaust teachings
The EUA provision was added to the federal Food, Drug, and Cosmetic Act (FDCA) in 2004 to give the government increased flexibility to respond to a chemical, biologic, nuclear, or radiation threat. When the pathway was created, special language was included for informational disclosures for individuals offered a medical product under an EUA. Specifically, under 21 U.S.C. § 360bbb-3(e)(1)(A)(ii)(III), each individual must be informed “of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.”
Although no court has interpreted this provision, the first segment of the subclause suggests that mandates are categorically prohibited, since each person must have “the option to accept or refuse.” But another plausible interpretation is to view segment two as a qualifier to segment one. According to this interpretation, the provision as a whole could be interpreted to dictate that, although a person has the option to refuse an EUA product, refusal can come with “consequences.” Under this interpretation, the legality of a mandate is likely to hinge on how the term “consequences” is defined. Since the term is not defined in the statute, statutory interpretation principles dictate that the word should be defined in ordinary terms within the context of the statute.
So we are on a slippery slope with different western nations and governmental bodies outbidding each other on who can undermine informed consent faster:
And then you had DOJ OLC manufacture this breach of humanity to justify…well just about anything: