VITAL Act of 2025
Sponsored By: Representative Green (TN)
Introduced
Summary
Expands criminal and civil liability for fraudulent vaccine trial data. This bill would create new federal crimes and civil pathways tied to falsified or concealed clinical trial information, change emergency authorization rules, and let injured people pursue both program compensation and court suits.
Show full summary
- Families and patients: People harmed by a vaccine could seek compensation through the federal Vaccine Injury Compensation Program and still file civil lawsuits in U.S. district court. Awards under the program would not be reduced by other damages and COVID-19 vaccine claims can be brought at any time.
- Medical research companies and sponsors: Companies that make fraudulent statements or hide material trial data would face criminal penalties, including fines and up to 5 years in prison. Sponsors would also have to certify no fraud when seeking certain emergency authorizations.
- Regulators and manufacturers: Health officials could revoke or deny emergency authorizations if they find trial fraud or concealment. The bill narrows liability protections for pandemic and epidemic products by adding fraud exceptions and sets procedures for hearings, including 30 days to rebut proposed findings and a five‑day deadline for requested documents.
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Bill Overview
Analyzed Economic Effects
4 provisions identified: 3 benefits, 0 costs, 1 mixed.
More ways to seek vaccine injury pay
If enacted, people with vaccine‑injury claims based on an HHS fraud finding could seek program money and sue in federal court at the same time. Court damages would not be reduced because you also got program money. For COVID‑19 vaccines, there would be no time limit to bring these suits; COVID‑19 would include all variants. To make a fraud finding, HHS would give the manufacturer 30 days to seek a hearing, set the date and format, and post the maker’s testimony online. The maker must provide requested documents no later than 5 days before the hearing; if it does not respond, the fraud finding would stand.
No liability shield for trial fraud
If enacted, companies could not use liability shields if they lied or hid material clinical‑trial data. This would apply under the Right to Try law and for pandemic countermeasures. Injured people could sue. If they win money, that award would not be cut because they got other related awards.
Criminal penalties for vaccine trial fraud
If enacted, making false or hidden vaccine trial data to the U.S. government would be a federal crime. A company or sponsor could face fines, and people could face up to 5 years in prison. This aims to deter fraud and protect public safety.
New fraud checks on emergency authorizations
If enacted, a sponsor seeking an emergency use authorization would have to certify it did not lie or hide material data. If the government later finds fraud or concealment, FDA could change or revoke the authorization. This targets company conduct, not direct household payments.
Sponsors & CoSponsors
Sponsor
Green (TN)
TN • R
Cosponsors
There are no cosponsors for this bill.
Roll Call Votes
No roll call votes available for this bill.
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