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Message: <blockquote data-quote="zubenelgenubi" data-source="post: 4956013" data-attributes="member: 63706">[URL unfurl="true"]https://www.icandecide.org/wp-content/uploads/2021/08/Letter-in-Response-to-DOJ-Slip-Opinion-Released-on-July-26-2021.pdf[/URL]Entrenched Principle to Not Coerce Acceptance of Unlicensed Medical ProductsTo be licensed, the FDA must find that a medical product is “safe for use and … effective in use.”3 Until licensed, a medical product remains investigational, even after issuance of an EUA. As the National Institutes of Health (“NIH”) explains with regard to a vaccine granted EUA: “The issuance of an EUA is different than an FDA approval (licensure) of a vaccine. A vaccine available under emergency use authorization is still considered investigational.”4 And as the FDA explains, “an investigational drug can also be called an experimental drug” because these two terms are synonymous.5 For example, the EUA fact sheet for an intravenous drug to treat H1N1 granted EUA by the FDA explains that it is “an experimental drug.”6 Similarly, after an EUA was grantedfor the COVID-19 vaccine co-developed by the NIH and Moderna, it was described by the NIH as an “[e]xperimental coronavirus vaccine.”7Long settled legal precedent establishes that it is not legal to coerce an individual to accept an unlicensed, and hence experimental, medical product. An individual must voluntarily agree, free from any undue influence, to accept same. This principle was first codified long-ago by American jurists.8 It was then incorporated into the United States Code, the Code of Federal Regulations, and guidance from federal health agencies. See e.g., 21 U.S.C. § 360bbb-0a (Even for patients with a life-threatening condition, an unlicensed medical product cannot be coerced, rather Congress required obtaining the patient’s “written informed consent.”) 42 U.S.C. § 9501 (Same for mental health patients);9 45 C.friend.R. § 46.116 (For an unlicensed medical product, the “Basic elements of informed consent” include that “participation is voluntary,” “refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled” and that consent be obtained without “coercion or undue influence.”);10 FDA Information Sheet: Informed Consent (“Coercion occurs when an overt threat of harm [such as expulsion from school or employment] is intentionally presented by one person to another in order to obtain compliance.”)11</blockquote>

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