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.
- Last Action
- 6/7/2021
Actions
- 2021-06-07Referred to the Subcommittee on Health.
- 2021-06-04Referred to the House Committee on Energy and Commerce.
- 2021-06-04Introduced in House
- 2021-06-04Introduced in House
CRS Summary
As of 2021-06-04 (00)
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.
Sourced from Congress.gov (public domain).
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