H.R. 3631 — VITAL Act of 2025

This section establishes a new criminal offense in 18 U.S.C. chapter 47 for medical research companies or sponsors that knowingly make fraudulent statements to or conceal material data from U.S. departments or agencies regarding clinical vaccine trials, punishable by fine under title 18, imprisonment for not more than five years, or both.

This section adds to the criteria under subsection (c) of Section 564 of the Federal Food, Drug, and Cosmetic Act for the Secretary of Health and Human Services to issue an emergency use authorization (EUA)—which permits unapproved medical products or unapproved uses of approved products during public health emergencies—a new paragraph (5) requiring that the authorization be based on a certification by a medical research company or sponsor that no fraudulent material statements were made and no material information was concealed with respect to the circumstances described under subsection (b)(1) (i.e., the Secretary's requisite findings of an emergency or potential emergency and lack of adequate alternatives) or the criteria under subsection (c).

This section revises the grounds for revocation of an emergency use authorization (EUA) by adding as a basis a Secretary determination that fraudulent material statements were made or material information was concealed with respect to the circumstances described under subsection (b)(1) (i.e., criteria for issuance, such as a public health emergency or credible risk of emergency) or the criteria under subsection (c) (i.e., conditions and limitations of the authorization).

This section revises the exceptions to liability protections for manufacturers and others under the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (Right to Try Act)—which authorizes terminally ill patients to access certain investigational drugs outside FDA processes—as follows: (1) in section 2(b)(1)(A), adding an exception for a fraudulent material statement made or material information concealed with respect to data from a clinical trial of the investigational drug; and (2) in section 2(b)(1)(B), expanding the existing exception to explicitly include such fraudulent statements or concealment.

This section expands exceptions to liability immunity for covered persons under the Public Readiness and Emergency Preparedness (PREP) Act (i.e., protections from tort liability for manufacture, distribution, administration, or use of covered countermeasures such as vaccines and drugs during public health emergencies) as follows: (1) in subsection (c)(1)(A), revises the definition of willful misconduct to include making a fraudulent material statement or concealing material information with respect to data collected from a clinical trial; (2) in subsection (c)(5)(A), conditions such immunity on the Secretary of Health and Human Services determining, after notice and opportunity for a hearing, that no such fraud or concealment by a covered person occurred with respect to clinical trial data; (3) in subsection (e), strikes paragraph (7); and (4) adds paragraph (11) prohibiting reduction of any damages award to a plaintiff due to other awards received for the same claim.

This section establishes an exception to the National Vaccine Injury Compensation Program's (VICP) bar on civil actions against vaccine manufacturers or sponsors (42 U.S.C. 300aa-22) if the Secretary of Health and Human Services determines, after notice and opportunity for a hearing, that the manufacturer made a fraudulent material statement or concealed material information regarding clinical trial data for a vaccine. (The VICP is a no-fault alternative compensation system for vaccine-related injuries that generally immunizes manufacturers from civil liability.) For such claims, a plaintiff may (1) seek VICP compensation and (2) concurrently pursue a civil action in U.S. district court, with any damages award not reduced by other compensation received for the same claim. Civil actions under this exception for COVID-19 vaccines (defined to include SARS-CoV-2 and all variations, with no termination date) may be brought at any time.

This section establishes a liability hearing process for vaccine manufacturers or sponsors determined by the Secretary of Health and Human Services to have made fraudulent material statements or concealed material information related to this Act. The Secretary must provide 30 days to refute the determination; the hearing requires document submission not more than five days prior, with format determined by the Secretary and all testimony published on the HHS website. Failure to respond upholds the fraud determination with full force under the Act.