To require the Commissioner of Food and Drugs to make available for public inspection all records of information submitted to the Food and Drug Administration in conjunction with authorizing the emergency use of, or licensing, a COVID-19 vaccine.

12/30/2022, 3:04 AM

This bill requires the Food and Drug Administration (FDA) to make publicly available all records of information submitted to the FDA in conjunction with the emergency use authorization or licensing of a COVID-19 vaccine.

Bill 117 hr 6133, also known as the "COVID-19 Vaccine Transparency Act," aims to increase transparency surrounding the authorization and licensing of COVID-19 vaccines by the Food and Drug Administration (FDA). The bill requires the Commissioner of Food and Drugs to make all records of information submitted to the FDA in relation to the emergency use or licensing of a COVID-19 vaccine available for public inspection.

This means that any data, studies, or other information submitted to the FDA by vaccine manufacturers seeking authorization or licensing for a COVID-19 vaccine must be made accessible to the public. This transparency is intended to provide greater accountability and ensure that the decision-making process behind the approval of COVID-19 vaccines is open and transparent.

By requiring the disclosure of these records, the bill aims to increase public trust in the FDA's regulatory process and provide the public with access to important information about the safety and efficacy of COVID-19 vaccines. This transparency is crucial in ensuring that the public can make informed decisions about their health and well-being during the ongoing COVID-19 pandemic.
Congress
117

Number
HR - 6133

Introduced on
2021-12-02

# Amendments
0

Sponsors
+5

Cosponsors
+5

Variations and Revisions

12/2/2021

Status of Legislation

Bill Introduced
Introduced to House
House to Vote
Introduced to Senate
Senate to Vote

Purpose and Summary

This bill requires the Food and Drug Administration (FDA) to make publicly available all records of information submitted to the FDA in conjunction with the emergency use authorization or licensing of a COVID-19 vaccine.

Bill 117 hr 6133, also known as the "COVID-19 Vaccine Transparency Act," aims to increase transparency surrounding the authorization and licensing of COVID-19 vaccines by the Food and Drug Administration (FDA). The bill requires the Commissioner of Food and Drugs to make all records of information submitted to the FDA in relation to the emergency use or licensing of a COVID-19 vaccine available for public inspection.

This means that any data, studies, or other information submitted to the FDA by vaccine manufacturers seeking authorization or licensing for a COVID-19 vaccine must be made accessible to the public. This transparency is intended to provide greater accountability and ensure that the decision-making process behind the approval of COVID-19 vaccines is open and transparent.

By requiring the disclosure of these records, the bill aims to increase public trust in the FDA's regulatory process and provide the public with access to important information about the safety and efficacy of COVID-19 vaccines. This transparency is crucial in ensuring that the public can make informed decisions about their health and well-being during the ongoing COVID-19 pandemic.
Alternative Names
Official Title as IntroducedTo require the Commissioner of Food and Drugs to make available for public inspection all records of information submitted to the Food and Drug Administration in conjunction with authorizing the emergency use of, or licensing, a COVID-19 vaccine.

Policy Areas
Health

Potential Impact
Cardiovascular and respiratory health•
Drug safety, medical device, and laboratory regulation•
Emergency medical services and trauma care•
Government information and archives•
Immunology and vaccination•
Infectious and parasitic diseases•
Licensing and registrations

Comments

Recent Activity

Latest Summary7/5/2022

This bill requires the Food and Drug Administration (FDA) to make publicly available all records of information submitted to the FDA in conjunction with the emergency use authorization or licensing of a COVID-19 vaccine.


Latest Action12/3/2021
Referred to the Subcommittee on Health.