H.R. 3705 · 117th Congress

To amend the Federal Food, Drug, and Cosmetic Act to include a safe harbor for communication of information with respect to a vaccine authorized for emergency use under such Act that is provided or distributed to a health care provider, and for other purposes.

Stage
In committee
Introduced
2021-06-04
Latest action
2021-06-07 · Referred to the Subcommittee on Health.

Summary

This bill prohibits using certain communications to establish that a vaccine authorized for emergency use violates specified laws relating to drug safety, such as laws concerning drug misbranding and the authorization of new drugs.

Specifically, the bill applies to certain communications about the use of such a vaccine that has been provided to certain health care entities. Such a communication must be (1) neither false nor misleading when measured objectively against the available information at the time; (2) accompanied by certain disclaimers, if required, including a statement identifying any differences between the communicated information and the vaccine's authorized labeling; and (3) based on competent and reliable scientific evidence.