Bill > HR3631

This bill, called the Vaccines in Trial and Liability Act of 2025 (VITAL Act of 2025), aims to criminalize fraudulent statements and material information concealment by medical research companies or sponsors during clinical vaccine trials. The bill creates a new federal criminal offense where a medical research company or sponsor that makes fraudulent statements or conceals material data from a U.S. government agency during a clinical vaccine trial can be fined and imprisoned. The legislation also modifies several existing laws to strengthen accountability, including amendments to the Federal Food, Drug, and Cosmetic Act that require vaccine authorization to be based on a certification of no fraudulent statements. Additionally, the bill provides mechanisms for revoking vaccine authorizations if fraud is discovered, removes liability protections for manufacturers who make fraudulent statements, and allows plaintiffs to seek damages in cases where material information was concealed during clinical trials. Notably, the bill includes specific provisions related to COVID-19 vaccines, allowing civil actions against manufacturers at any time if fraudulent statements are discovered. The legislation also establishes a formal hearing process where vaccine manufacturers can respond to fraud allegations, with the Secretary of Health and Human Services determining the hearing format and potentially publishing testimony.

Business and Industry

https://www.congress.gov/bill/119th-congress/house-bill/3631/all-info