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.

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.

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Timeline

1. 4 June 2021

   Introduced

   Introduced in House

   Source: IntroReferral

2. 4 June 2021

   Introduced

   Referred to the House Committee on Energy and Commerce.

   Source: IntroReferral

3. 4 June 2021

   Introduced

   Introduced in House

   Source: IntroReferral

4. 7 June 2021

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in House · 4 June 2021 · Official file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 4 June 2021

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 4 June 2021

  ViewDownloadOpen at official source

• Introduced in House

  summary · EN · 4 June 2021

  Open at official source

Sponsors

• H. Griffith · R · Sponsor
• · hsif00 · Standing

Related records

No cross-record relationships stored yet.