How do these guys get away with mandates on drugs that aren't licensed when the FDA code says that it has to be voluntary?
https://www.law.cornell.edu/us....code/text/21/360bbb-
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How do these guys get away with mandates on drugs that aren't licensed when the FDA code says that it has to be voluntary?
https://www.law.cornell.edu/us....code/text/21/360bbb-
Kathy Johnson
(2) that, based on the totality of scientific evidence available to the Secretary, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that—
(A) the product may be effective in diagnosing, treating, or preventing—
(i) such disease or condition; or
(ii) a serious or life-threatening disease or condition caused by a product authorized under this section, approved or cleared under this chapter, or licensed under section 351 of the Public Health Service Act [42 U.S.C. 262], for diagnosing, treating, or preventing such a disease or condition caused by such an agent; and
( the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product, taking into consideration the material threat posed by the agent or agents identified in a declaration under subsection (b)(1)(D), if applicable;
(3) that there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition;
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