Since the three COVID-19 vaccines were granted emergency use authorization (EUA) in the U.S., the question of whether employers, schools, and others can mandate the vaccines has been heavily debated. At the crux of the debate is Section 564 of the Food, Drug, and Cosmetic Act (FDCA), codified at 21 U.S.C. § 360bbb-3 (Section 564), which provides “required conditions” for EUA products including that:
the Secretary … shall … establish … [a]ppropriate conditions designed to ensure that individuals to whom the product is administered are 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.
On July 26, 2021, an opinion written by the Acting Assistant Attorney General of the Department of Justice (“DOJ”) was released to the public. The opinion was addressed to the Deputy Counsel to the President, part of an administration whose stated goal is to vaccinate as many Americans as possible, and concludes “that section 564 of the FDCA does not prohibit public or private entities from imposing vaccination requirements, even when the only vaccines available are those authorized under EUAs.”
ICAN promptly and thoroughly responded in a letter to the DOJ. ICAN’s attorneys explain in careful detail how this conclusion runs contrary to the text of Section 564, its statutory framework, the history surrounding its passage, and its consistent interpretation by the FDA, Centers for Disease Control and Prevention (CDC), the Department of Defense (DOD), and other federal agencies. ICAN’s response highlights the experimental nature of EUA products and the long settled legal precedent which establishes that it is not legal to coerce an individual to accept an experimental product.
It further provides the historical background and evidence that Congress’ intent in enacting Section 564 was to provide only one limited exception to the option to accept or refuse EUA products – that exception applies only to military personnel and only when national security is at risk. Federal agencies have also historically interpreted Section 564 as a prohibition on mandates of EUA products, and ICAN’s letter highlights these interpretations from the CDC, FDA, DOD, and the U.S. General Services Administration.
ICAN also pointed out it would be illogical that Congress would require that individuals be informed of a freedom of choice if that choice is illusory at the whim of any public or private entity, and concluded its letter by urging the DOJ to revise its Slip Opinion and enforce Section 564 by making clear that it prohibits entities from requiring the use of an EUA product.
Read the full letter here and share it far and wide so that the correct interpretation of Section 564 and the fundamental right to be free from coercion with respect to unlicensed medical products ultimately prevails.
