H.R. 3631
VITAL Act of 2025
Sponsor: Mark E. Green · 0 cosponsors
Official summary
No official summary yet.
Text of the bill
Section 319F–3 of the Public Health Service Act (42 U.S.C. 247d–6d) is amended—
(1) in subsection (c)—
(A) in paragraph (1)(A)—
(i) by redesignating clauses (i), (ii), and (iii) as subclauses (I), (II), and (III), respectively;
(ii) by moving subclauses (I), (II), and (III), as redesignated, 2 ems to the right;
(iii) by striking the period at the end of subclause (III) and inserting ; and, as redesignated;
(iv) by striking subsection (d), denote and inserting the following:
subsection (d)—
(i) denote
; and
(v) by adding at the end the following:
(ii) includes—
(I) making a fraudulent material statement with respect to data collected from a clinical trial; or
(II) concealing material information with respect to data collected from a clinical trial.
; and
(B) in paragraph (5)(A)—
(i) in the matter preceding clause (i), by striking subsection (d) if— and inserting subsection (d)—;
(ii) in clause (i)—
(I) by inserting if before neither; and
(II) by striking or at the end;
(iii) in clause (ii)—
(I) by inserting if before such an enforcement; and
(II) by striking the period at the end and inserting ; and; and
(iv) by adding at the end the following:
(iii) unless the Secretary determines, after notice and opportunity for a hearing, that a fraudulent material statement was made, or material information was concealed, by a covered person with respect to data collected from a clinical trial of a covered countermeasure.
; and
(2) in subsection (e)—
(A) by striking paragraph (7); and
(B) by adding at the end the following:
(11) Award of damages. Notwithstanding any other provision of law, the amount of an award of damages made to a plaintiff may not be reduced because of any other award for damages the plaintiff may receive as a result of such claim.