Enforcing Emergency Authorization Rules

ICAN DEMANDS THAT THE FDA DO ITS JOB WITH REGARD TO ENFORCING THE TERMS OF ITS EMERGENCY USE AUTHORIZATIONS

ICAN filed a petition asking the FDA to do its job and enforce the terms of the COVID-19 vaccine emergency use authorizations which are being violated by public health authorities across the country who are spreading vaccine misinformation.

After ICAN’s legal team spent countless hours and resources doing the FDA’s job of policing public health authorities’ inaccurate and misleading messaging regarding COVID-19 vaccines, ICAN’s attorneys petitioned the FDA on March 24, 2021 to do its job!

ICAN has asked the FDA to enforce its conditions of the emergency use authorization issued to three manufacturers.  In those EUAs, pursuant to federal law, the FDA required certain specific conditions that must be met when promoting these vaccines.  Among those are that all promotional material regarding the vaccines “clearly and conspicuously shall state that: This product has not been approved or licensed by FDA, but has been authorized for emergency use by FDA.”  This is simply not occurring.

Not only are public health authorities not disclosing this crucial information, mandated by federal law, but they are stating that the vaccines are, in fact, “approved” by the FDA.  ICAN also requested that the FDA make clear that the same federal statute requires that all individuals be notified of the known risks and benefits of the vaccines and are given the right to refuse.  ICAN has made clear to the FDA that “It is imperative that the FDA make clear that all individuals must retain their statutory right to refuse these unapproved products without facing penalty, coercion, or retaliation of any kind.”  ICAN awaits a response to its most recent Petition.

Specifically, the Petition requests the following actions by the FDA:

1. “All descriptive printed matter, advertising, and promotional material, relating to the use of the [] COVID-19 Vaccine[s] shall be consistent with the authorized labeling, as well as the terms set forth in [each] EUA…”;
2. “All descriptive printed matter, advertising, and promotional material relating to the use of the Janssen COVID-19 Vaccine clearly and conspicuously shall state that: This product has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 18 years of age and older…”; and
3. “[I]ndividuals to whom the product is administered are informed of the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown; and 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.”

ICAN will follow through and continue to ensure the terms of the emergency use authorization are complied with by health departments until the FDA adequately does its job itself.  ICAN promotes accurate information regarding vaccines and will not stand for misinformation being shared, especially from “trusted” public health agencies and officials.