As you may recall from prior legal updates, ICAN has been enforcing the FDA’s conditions in its emergency use authorizations (EUA) for the COVID-19 vaccines which prohibit making claims that these vaccines were approved as safe and effective.  ICAN, for example, has successfully forced public health departments, including in New York and Michigan, to remove false claims about the safety and approval of these vaccines.

But because this is supposed to be the FDA’s job, ICAN filed a Citizen Petition with the FDA on March 29, 2021 demanding that the agency do its job and enforce the conditions it created when it granted the EUAs for the COVID-19 vaccines.  This includes demanding that the FDA assure that state health departments stop making false claims about these vaccines in violation of the FDA’s EUAs.  The FDA could have easily produced this result with a simple letter to each state health department asking them to not violate the EUAs.

Instead, the FDA has done nothing.  Six months after filing our petition, the FDA has stated: “Because of the existence of other FDA priorities, we have not been able to reach a decision on the petition at this time … We will respond to your petition as soon as we have reached a decision on your request.”

It is highly concerning, and telling, that enforcement of its own EUAs of a novel product being promoted, administered, and mandated nationwide is not an “FDA priority.”  It also seems apparent that the FDA aims to respond to this petition only after it is moot: that is, after the vaccines are licensed and the EUAs are no longer in place.

If the FDA cannot be trusted to enforce its own simple conditions for its EUAs, it is understandable that the public does not trust them on more complex decisions.  ICAN will continue to shed light on the failings of our public health authorities.