,,ii #aaeth ,,congress #ast ,session ,s4 #bjeg ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,november #a1 #bjag ,ms4 ,baldwin 7for herself1 ,mrs4 ,feinstein1 ,ms4 ,harris1 ,ms4 ,hassan1 ,mr4 ,markey1 ,mrs4 ,shaheen1 and ,mr4 ,udall7 introduced the following bill2 which was read twice and referred to the ,committee on ,homeland ,security and ,governmental ,affairs ,a ,,bill ,to prevent conflicts of interest that stem from the revolving door that raises concerns about the independence of pharmaceutical regulators4 #a4 ,short title ,this ,act may be cited as the ,pharmaceutical ,regulation ,conflict of ,interest ,act4 #b4 ,requirements relating to slowing the revolving door among pharmaceutical regulators ,the ,ethics in ,government ,act of #aigh 7#e ,u4,s4,c4 ,app47 is amended by adding at the end the following3 ,,vi ,special requirements for pharmaceutical regulators #fja4 ,definitions 7a7 ,in general ,in this title1 the terms designated agency ethics official and executive branch have the meanings given those terms under section #aji4 7b7 ,other definitions ,in this title3 7#a7 ,covered pharmaceutical regulator ,the term covered pharmaceutical regulator means an officer or employee of a covered pharmaceutical regulatory agency who occupies-- 7,a7 a supervisory position classified at or above ,,gs-#ac of the ,general ,schedule2 7,b7 in the case of a position not under the ,general ,schedule1 a supervisory position for which the rate of basic pay is not less than the minimum rate of basic pay for ,,gs-#ac of the ,general ,schedule2 or 7,c7 any other supervisory position determined to be of equal classification by the ,director4 7#b7 ,covered pharmaceutical regulatory agency ,the term covered pharmaceutical regulatory agency-- 7,a7 means an agency whose primary responsibility is to regulate the manufacture1 distribution1 or sale of drugs 7as defined in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba77 or biological products 7as defined in section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb772 and 7,b7 includes-- 7i7 the ,drug ,enforcement ,administration2 and 7ii7 the ,food and ,drug ,administration4 7#c7 ,director ,the term ,director means the ,director of the ,office of ,government ,ethics4 7#d7 ,former client ,the term former client-- 7,a7 means a person for whom the covered pharmaceutical regulator served personally as an agent1 attorney1 or consultant during the #b-year period ending on the date 7after such service7 on which the covered pharmaceutical regulator begins service in the ,federal ,government2 and 7,b7 does not include-- 7i7 instances in which the service provided was limited to a speech or similar appearance2 or 7ii7 a client of the former employer of the covered pharmaceutical regulator to whom the covered pharmaceutical regulator did not personally provide such services4 7#e7 ,former employer ,the term former employer-- 7,a7 means a person for whom a covered pharmaceutical regulator served as an employee1 officer1 director1 trustee1 or general partner during the #b-year period ending on the date 7after such service7 on which the covered pharmaceutical regulator begins service in the ,federal ,government2 and 7,b7 does not include-- 7i7 any entity in the ,federal ,government1 including an executive branch agency2 7ii7 a ,state or local government2 7iii7 the ,district of ,columbia2 7iv7 an ,indian tribe1 as defined in section #d of the ,indian ,self-,determination and ,education ,assistance ,act 7#be ,u4,s4,c4 #ecjd72 or 7v7 the government of a territory or possession of the ,united ,states4 #fjb4 ,conflict of interest and eligibility standards for pharmaceutical regulators 7a7 ,in general ,a covered pharmaceutical regulator shall not make1 participate in making1 or in any way attempt to use the official position of the covered pharmaceutical regulator to influence a particular matter that provides a direct and substantial pecuniary benefit for a former employer or former client of the covered pharmaceutical regulator4 7b7 ,recusal ,a covered pharmaceutical regulator shall recuse himself or herself from any official action that would violate subsection 7a74 7c7 ,waiver 7#a7 ,in general ,the head of the covered pharmaceutical regulatory agency employing a covered pharmaceutical regulator1 in consultation with the ,director1 may grant a written waiver of the restrictions under subsection 7a7 if1 and to the extent that1 the head of the covered pharmaceutical regulatory agency certifies in writing that-- 7,a7 the application of the restriction to the particular matter is inconsistent with the purposes of the restriction2 or 7,b7 it is in the public interest to grant the waiver4 7#b7 ,publication ,the ,director shall make each waiver under paragraph 7#a7 publicly available on the ,web site of the ,office of ,government ,ethics4 #fjc4 ,negotiating future private sector employment 7a7 ,prohibition ,except as provided in subsection 7c71 and notwithstanding any other provision of law1 a covered pharmaceutical regulator may not participate in any particular matter which involves1 to the knowledge of the covered pharmaceutical regulator1 an individual or entity with whom the covered pharmaceutical regulator is in negotiations of future employment or has an arrangement concerning prospective employment4 7b7 ,disclosure of employment negotiations 7#a7 ,in general ,if a covered pharmaceutical regulator begins any negotiations of future employment with another person1 or an agent or intermediary of another person1 or other discussion or communication with another person1 or an agent or intermediary of another person1 mutually conducted with a view toward reaching an agreement regarding possible employment of the covered pharmaceutical regulator1 the covered pharmaceutical regulator shall notify the designated agency ethics official of the covered pharmaceutical regulatory agency employing the covered pharmaceutical regulator regarding the negotiations1 discussions1 or communications4 7#b7 ,information ,a designated agency ethics official receiving notice under paragraph 7#a71 after consultation with the ,director1 shall inform the covered pharmaceutical regulator of any potential conflicts of interest involved in any negotiations1 discussions1 or communications with the other person and the applicable prohibitions4 7#c7 ,publication ,the ,director1 after receiving notice under paragraph 7#a71 shall make publicly available on the ,web site of the ,office of ,government ,ethics the name of the covered pharmaceutical regulator and the name of the private person involved in the negotiations or arrangement concerning prospective employment of the covered pharmaceutical regulator4 7c7 ,waivers only when exceptional circumstances exist 7#a7 ,in general ,the head of a covered pharmaceutical regulatory agency may only grant a waiver of the prohibition under subsection 7a7 if the head determines that exceptional circumstances exist4 7#b7 ,review and publication ,for any waiver granted under paragraph 7#a71 the ,director shall-- 7,a7 review the circumstances relating to the waiver and the determination that exceptional circumstances exist2 and 7,b7 make the waiver publicly available on the ,web site of the ,office of ,government ,ethics1 which shall include-- 7i7 the name of the private person involved in the negotiations or arrangement concerning prospective employment of the covered pharmaceutical regulator2 and 7ii7 the date on which the negotiations or arrangement commenced4 7d7 ,scope ,for the purposes of this section1 the term negotiations of future employment is not limited to discussions of specific terms or conditions of employment in a specific position4 #fjd4 ,recordkeeping ,the ,director shall-- 7#a7 receive all employment histories1 recusal and waiver records1 and other disclosure records for covered pharmaceutical regulators necessary for monitoring compliance with this title1 and make those records publicly available on the ,web site of the ,office of ,government ,ethics2 7#b7 promulgate rules and regulations1 in consultation with the ,director of the ,office of ,personnel ,management and the ,attorney ,general1 to implement this title2 7#c7 provide guidance and assistance where appropriate to facilitate compliance with this title2 7#d7 review and1 where necessary1 assist designated agency ethics officials in providing advice to covered pharmaceutical regulators regarding compliance with this title2 and 7#e7 if the ,director determines that a violation of this title may have occurred1 and in consultation with the designated agency ethics official and the ,counsel to the ,president1 refer the compliance case to the ,united ,states ,attorney for the ,district of ,columbia for enforcement action4 #fje4 ,penalties and injunctions 7a7 ,criminal penalties 7#a7 ,in general ,any person who violates section #fjb or #fjc shall be fined under title #ah1 ,united ,states ,code1 imprisoned for not more than #a year1 or both4 7#b7 ,willful violations ,any person who willfully violates section #fjb or #fjc shall be fined under title #ah1 ,united ,states ,code1 imprisoned for not more than #e years1 or both4 7b7 ,civil enforcement 7#a7 ,in general ,the ,attorney ,general may bring a civil action in an appropriate district court of the ,united ,states against any person who violates1 or whom the ,attorney ,general has reason to believe is engaging in conduct that violates1 section #fjb or #fjc4 7#b7 ,civil penalty 7,a7 ,in general ,upon proof by a preponderance of the evidence that a person violated section #fjb or #fjc1 the court shall impose a civil penalty of not more than the greater of-- 7i7 #ajj1jjj for each violation2 or 7ii7 the amount of compensation the person received or was offered for the conduct constituting the violation4 7,b7 ,rule of construction ,a civil penalty under this subsection shall be in addition to any other criminal or civil statutory1 common law1 or administrative remedy available to the ,united ,states or any other person4 7#c7 ,injunctive relief 7,a7 ,in general ,in a civil action brought under paragraph 7#a7 against a person1 the ,attorney ,general may petition the court for an order prohibiting the person from engaging in conduct that violates section #fjb or #fjc4 7,b7 ,standard ,the court may issue an order under subparagraph 7,a7 if the court finds by a preponderance of the evidence that the conduct of the person violates section #fjb or #fjc4 7,c7 ,rule of construction ,the filing of a petition seeking injunctive relief under this paragraph shall not preclude any other remedy that is available by law to the ,united ,states or any other person4 4 #c4 ,slowing the revolving door from pharmaceutical regulatory agency into private sector representational activities 7a7 ,in general ,section #bjg of title #ah1 ,united ,states ,code1 is amended-- 7#a7 by redesignating subsections 7e7 through 7l7 as subsections 7f7 through 7m71 respectively2 and 7#b7 by inserting after subsection 7d7 the following3 7e7 ,restrictions on employment for pharmaceutical regulators 7#a7 ,in general ,in addition to the restrictions set forth in subsections 7a71 7b71 7c71 and 7d71 a covered pharmaceutical regulator shall not-- 7,a7 during the #b-year period beginning on the date on which his or her employment as a covered pharmaceutical regulator ceases-- 7i7 knowingly act as agent or attorney for1 or otherwise represent1 any other person for compensation 7except the ,united ,states7 in any formal or informal appearance before2 7ii7 with the intent to influence1 make any oral or written communication on behalf of any other person 7except the ,united ,states7 to2 or 7iii7 knowingly aid1 advise1 or assist in-- 7,i7 representing any other person 7except the ,united ,states7 in any formal or informal appearance before2 or 7,,ii7 making1 with the intent to influence1 any oral or written communication on behalf of any other person 7except the ,united ,states7 to1 any court of the ,united ,states1 or any officer or employee thereof1 in connection with any judicial or other proceeding1 which was actually pending under his or her official responsibility as a covered pharmaceutical regulator during the #a-year period ending on the date on which his or her employment as a covered pharmaceutical regulator ceases or in which he or she participated personally and substantially as a covered pharmaceutical regulator2 or 7,b7 during the #b-year period beginning on the date on which his or her employment as a covered pharmaceutical regulator ceases-- 7i7 knowingly act as a lobbyist or agent for1 or otherwise represent1 any other person for compensation 7except the ,united ,states7 in any formal or informal appearance before2 7ii7 with the intent to influence1 make any oral or written communication or conduct any lobbying activities on behalf of any other person 7except the ,united ,states7 to2 or 7iii7 knowingly aid1 advise1 or assist in-- 7,i7 representing any other person 7except the ,united ,states7 in any formal or informal appearance before2 or 7,,ii7 making1 with the intent to influence1 any oral or written communication or conduct any lobbying activities on behalf of any other person 7except the ,united ,states7 to1 any department or agency of the executive branch or ,congress 7including any committee of ,congress71 or any officer or employee thereof1 in connection with any matter that is pending before the department1 the agency1 or ,congress4 7#b7 ,penalty ,any person who violates paragraph 7#a7 shall be punished as provided in section #baf4 7#c7 ,definitions ,in this subsection-- 7,a7 the term covered pharmaceutical regulator has the meaning given that term in section #fja of the ,ethics in ,government ,act of #aigh 7#e ,u4,s4,c4 ,app472 and 7,b7 the terms lobbying activities and lobbyist have the meanings given those terms in section #c of the ,lobbying ,disclosure ,act of #aiie 7#b ,u4,s4,c4 #afjb74 4 7b7 ,technical and conforming amendments 7#a7 ,section #ajc7;a7 of the ,honest ,leadership and ,open ,government ,act of #bjjg 7#b ,u4,s4,c4 #dgjb7;a77 is amended by striking section #bjg7;e7 each place it appears and inserting section #bjg7;f74 7#b7 ,section #bjg of title #ah1 ,united ,states ,code1 as amended by subsection 7a71 is amended-- 7,a7 in subsection 7g77#a71 as so redesignated1 by striking or 7e7 and inserting or 7f72 7,b7 in subsection 7j77#a77;,b71 as so redesignated1 by striking subsection 7f7 and inserting subsection 7g72 and 7,c7 in subsection 7k71 as so redesignated-- 7i7 in paragraph 7#a77;,b71 by striking 7#be ,u4,s4,c4 #dej;i7j77 and inserting 7#be ,u4,s4,c4 #ecbc7;j772 7ii7 in paragraph 7#b71 in the matter preceding subparagraph 7,a71 by striking and 7e7 and inserting 7e71 and 7f72 7iii7 in paragraph 7#d71 by striking and 7e7 and inserting 7e71 and 7f72 and 7iv7 in paragraph 7#g7-- 7,i7 in subparagraph 7,a71 by striking and 7e7 and inserting 7e71 and 7f72 and 7,,ii7 in subparagraph 7,b77ii71 in the matter preceding subclause 7,i71 by striking subsections 7c71 7d71 or 7e7 and inserting subsection 7c71 7d71 7e71 or 7f74 7#c7 ,section #ada7;b77#d7 of the ,trade ,act of #aigd 7#ai ,u4,s4,c4 #baga7;b77#d77 is amended by striking section #bjg7;f77#c7 and inserting #bjg7;g77#c74 7#d7 ,section #ghjb7;b77#c77;,b7 of the ,internal ,revenue ,code of #aihf is amended by striking and 7f7 of section #bjg and inserting and 7g7 of section #bjg4 7#e7 ,section #caje7;c7 of the ,,usec ,privatization ,act 7#db ,u4,s4,c4 #bbig;h-#c7;c77 is amended by striking and 7d7 and inserting 7d71 and 7e74 7#f7 ,section #ajf7p77#f77;,i77ii7 of title #di1 ,united ,states ,code1 is amended by striking and 7f7 of section #bjg and inserting and 7g7 of section #bjg4 #d4 ,severability ,if any provision of this ,act or any amendment made by this ,act1 or any application of such provision or amendment to any person or circumstance1 is held to be unconstitutional1 the remainder of the provisions of this ,act and the amendments made by this ,act and the application of the provision or amendment to any other person or circumstance shall not be affected4