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.
Legislative Progress
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
59pct
3d open
vs 9,698 other HR bills in the 117th — cohort avg 63d
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.
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Filing registrants (1)
2021 · second_quarter · Health Issues
Issues related to HR 3 "Lower Drug Costs Now Act of 2019"; issues related to drug pricing; issues related to influenza vaccines; issues related to RSV Access; issues related to routine immunization rates; issues related to HR 1319 "American Rescue Plan"; general issues related to trade; general issues related to AMP CAP; general issues related to vaccines; issues related to 340B; issues related to insulin pricing; issues related to funding for Pandemic influenza; issues related to Flu Infrastructure Funding; issues related to HR 1978 "Protecting Seniors Through Immunization Act"; issues related to HR 2170 "Helping Adults Protect Immunity Act"; issues related to HR 550 "Immunization Infrastructure Modernization Act"; issues related to HR 2437 "Strengthening the Vaccines for Children Act of 2021"; issues related to HR 3655 "Vaccine Injury Compensation Modernization Act"; issues related to vaccine authorized for emergency use under HR 3705; issues related to RX to OTC switch; issues related to S.1132 "EPI Act"; issues related to S.2164 "Lower Costs, More Cures Act of 2021; and issues related to HR 19 "Lower Costs, More Cures Act of 2021".
Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Congress.gov source codes: 1000, Intro-H
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Sources: Congress.gov
Client expense: $980,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE