,i #aahth ,,congress #b;d ,session ,h4 ,r4 #hchj ,,in ,,the ,,house ,,of ,,representatives ,may #ad1 #bjbd ,mr4 ,green of ,tennessee introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committee on the ,judiciary1 for a period to be subsequently determined by the ,speaker1 in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned ,a ,,bill ,to criminalize fraudulent statements made with respect to clinical vaccine trials4 #a4 ,short title ,this ,act may be cited as the ,vaccines ,in ,trial ,and ,liability ,act of #bjbd or the ,,vital ,act of #bjbd4 #b4 ,medical research company or sponsor 7a7 ,in general ,chapter #dg of title #ah1 ,united ,states ,code1 is amended by adding at the end the following3 #ajda4 ,clinical vaccine trial fraud ,whoever1 being a medical research company or sponsor1 makes a fraudulent statement to1 or conceals from1 any department or agency of the ,united ,states1 any material data collected from a clinical vaccine trial1 shall be fined under this title1 imprisoned not more than #e years1 or both4 4 7b7 ,clerical amendment ,the table of sections for chapter #dg of title #ah1 ,united ,states ,code1 is amended by adding at the end the following3 #ajda4 ,clinical vaccine trial fraud4 4 #c4 ,scope of authorization ,section #efd7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c7;c77 is amended-- 7#a7 in paragraph 7#d71 by striking and 7#b7 by redesignating paragraph 7#e7 as paragraph 7#f72 and 7#c7 by inserting after paragraph 7#d7 the following3 7#e7 the authorization is based on a certification by a medical research company or sponsor that no fraudulent material statements were made1 and no material information was concealed1 with respect to the circumstances described under subsection 7b77#a7 or the criteria under this subsection2 and 4 #d4 ,revision and revocation ,section #efd7;g77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c7;g77#b77 is amended-- 7#a7 in subparagraph 7,b71 by striking or at the end2 7#b7 by redesignating subparagraph 7,c7 as subparagraph 7,d72 and 7#c7 by inserting after subparagraph 7,b7 the following3 7,c7 the ,secretary determines that fraudulent material statements were made1 or material information was concealed1 with respect to the circumstances described under subsection 7b77#a7 or the criteria under subsection 7c72 or 4 #e4 ,exception to limitation on liability ,section #b7;b77#a7 of the ,trickett ,wendler1 ,frank ,mongiello1 ,jordan ,mc,linn1 and ,matthew ,bellina ,right to ,try ,act of #bjag 7#ba ,u4,s4,c4 #cfj;bbb-#j;a note7 is amended-- 7#a7 in subparagraph 7,a71 by inserting 1 unless a fraudulent material statement was made1 or material information was concealed1 with respect to data collected from a clinical trial of the investigational drug before the semicolon2 and 7#b7 in subparagraph 7,b71 by inserting 1 including a fraudulent material statement made1 or material information concealed1 with respect to data collected from a clinical trial of the investigational drug before the period4 #f4 ,exception to targeted liability protections for pandemic and epidemic products ,section #cai;,f-#c of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;d7c77 is amended-- 7#a7 in subsection 7c7-- 7,a7 in paragraph 7#a77;,a7-- 7i7 by redesignating clauses 7i71 7ii71 and 7iii7 as subclauses 7,i71 7,,ii71 and 7,,iii71 respectively2 7ii7 by moving subclauses 7,i71 7,,ii71 and 7,,iii71 as redesignated1 #b ems to the right2 7iii7 by striking the period at the end of subclause 7,,iii71 as redesignated2 7iv7 by striking subsection 7d71 denote and inserting the following3 subsection 7d7-- 7i7 denote 2 and 7v7 by adding at the end the following3 7ii7 includes-- 7,i7 making a fraudulent material statement with respect to data collected from a clinical trial2 or 7,,ii7 concealing material information with respect to data collected from a clinical trial4 2 and 7,b7 in paragraph 7#e77;,a7-- 7i7 in the matter preceding clause 7i71 by striking subsection 7d7 if-- and inserting subsection 7d7--2 7ii7 in clause 7i7-- 7,i7 by inserting if before neither2 and 7,,ii7 by striking or at the end2 7iii7 in clause 7ii7-- 7,i7 by inserting if before such an enforcement2 and 7,,ii7 by striking the period at the end and inserting 2 and2 and 7iv7 by adding at the end the following3 7iii7 unless the ,secretary determines1 after notice and opportunity for a hearing1 that a fraudulent material statement was made1 or material information was concealed1 by a covered person with respect to data collected from a clinical trial of a covered countermeasure4 2 7#b7 in subsection 7d7 by adding at the end the following3 7#aa7 ,award of damages ,notwithstanding any other provision of law1 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 claim4 2 and 7#c7 subsection 7e71 by striking paragraph 7#g74 #g4 ,national ,vaccine ,injury ,compensation ,program ,section #babb of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;aa-#bb7 is amended by adding at the end the following3 7f7 ,liability 7#a7 ,fraudulent material statement ,no civil action against a vaccine manufacturer or vaccine sponsor shall be barred under this part if the ,secretary determines1 after notice and opportunity for a hearing1 that a fraudulent material statement was made1 or material information was concealed1 by a vaccine manufacturer with respect to data collected from a clinical trial of a vaccine4 7#b7 ,award of damages 7,a7 ,in general ,notwithstanding any other provision of law1 an plaintiff bringing a claim pursuant to paragraph 7#a7 may-- 7i7 seek compensation under the program established under this part2 and 7ii7 concurrently bring an action with respect to such claim in any appropriate ,united ,states district court4 7,b7 ,award of damages ,notwithstanding any other provision of law1 the amount of an award of damages made to a plaintiff for a claim pursuant to paragraph 7#a7 may not be reduced on the basis of any other damages the plaintiff may receive as a result of such claim4 7#c7 ,applicability with respect to ,,covid-#ai vaccine ,notwithstanding any other provision of law1 a civil action against a vaccine manufacturer pursuant to paragraph 7#a7 with respect to a vaccine related to ,,covid-#ai may be made at any time4 7#d7 ,,covid-#ai definition ,in this section1 the term ,,covid-#ai means the coronavirus disease caused by the severe acute respiratory syndrome coronavirus #b or the ,,sars-,co,v-#b4 ,this term also relates to any and all variations of that virus of which there is no termination date for this term4 #h4 ,liability hearing 7a7 ,fraudulent material or statements ,in the case that the ,secretary of ,health and ,human ,services determines that a vaccine manufacturer or vaccine sponsor has made fraudulent material or statements or concealed material information with respect to a situation described in this ,act1 or an amendment made by this ,act1 the ,secretary shall and provide such manufacturer or sponsor #cj days to refute a determination made in a hearing described in subsection 7b74 7b7 ,hearing 7#a7 ,in general ,the ,secretary shall determine a date1 time1 and format for a hearing under this subsection1 including a requirement that the vaccine manufacturer or vaccine sponsor provide any requested document to the ,secretary not more than five days before the hearing4 7#b7 ,format ,the format of a hearing under paragraph 7#a7 shall be determined by the ,secretary4 7#c7 ,publication ,any written or verbal testimony submitted by the vaccine manufacturer or vaccine sponsor at the hearing under paragraph 7#a7 shall be published on the internet website of the ,secretary of ,health and ,human ,services4 7c7 ,does not provide information ,in the case that the vaccine manufacturer or vaccine sponsor does not respond to the ,secretary in accordance with this section1 an initial determination of fraud shall be maintained and shall have the full force and effect of this ,act4