115 S2057 IS: Pharmaceutical Regulation Conflict of Interest Act U.S. Senate 2017-11-01 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
II 115th CONGRESS1st Session S. 2057 IN THE SENATE OF THE UNITED STATES November 1, 2017 Ms. Baldwin (for herself, Mrs. Feinstein, Ms. Harris, Ms. Hassan, Mr. Markey, Mrs. Shaheen, and Mr. Udall) introduced the following bill; 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 regulators.
1.
Short title
This Act may be cited as the Pharmaceutical Regulation Conflict of Interest Act.
2.
Requirements relating to slowing the revolving door among pharmaceutical regulators
The Ethics in Government Act of 1978 (5 U.S.C. App.) is amended by adding at the end the following: <enum>VI</enum><header>Special requirements for pharmaceutical regulators</header> <section id="id883D843EA4134E159F1FDA4B23A35B31"><enum>601.</enum><header>Definitions</header> <subsection id="idC1ED874A6FD14CE89F2DC32872CB38C6"><enum>(a)</enum><header>In general</header><text>In this title, the terms <term>designated agency ethics official</term> and <term>executive branch</term> have the meanings given those terms under section 109.</text> </subsection><subsection id="id122E093B553540A081BE068F1A66FE54"><enum>(b)</enum><header>Other definitions</header><text display-inline="yes-display-inline">In this title:</text> <paragraph id="id17A93DE839E94098A89C88CA51C8DB97"><enum>(1)</enum><header>Covered pharmaceutical regulator</header><text>The term <term>covered pharmaceutical regulator</term> means an officer or employee of a covered pharmaceutical regulatory agency who occupies—</text> <subparagraph id="id27C66B88184140E9AEEBF756D9D69D0B"><enum>(A)</enum><text>a supervisory position classified at or above GS–13 of the General Schedule;</text> </subparagraph><subparagraph id="idECAB0CEB6E874952971CE9727B5D361B"><enum>(B)</enum><text>in the case of a position not under the General Schedule, a supervisory position for which the rate of basic pay is not less than the minimum rate of basic pay for GS–13 of the General Schedule; or</text> </subparagraph><subparagraph id="id70851517E99745D4A0F10F05DDC416A8"><enum>(C)</enum><text>any other supervisory position determined to be of equal classification by the Director.</text> </subparagraph></paragraph><paragraph commented="no" id="idddc152595ab74122a379c189c99e82a0"><enum>(2)</enum><header>Covered pharmaceutical regulatory agency</header><text>The term <quote>covered pharmaceutical regulatory agency</quote>—</text> <subparagraph commented="no" id="id903E49612A3F46699D71155FC76AA616"><enum>(A)</enum><text>means an agency whose primary responsibility is to regulate the manufacture, distribution, or sale of drugs (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/321">21 U.S.C. 321</external-xref>)) or biological products (as defined in section 351 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262</external-xref>)); and</text> </subparagraph><subparagraph commented="no" id="id9222EEFBC9B649FE97FDA503E50F604D"><enum>(B)</enum><text>includes—</text> <clause commented="no" id="idEC97331D7FE145798811F08746DE1582"><enum>(i)</enum><text>the Drug Enforcement Administration; and</text> </clause><clause commented="no" id="idBF8AAE014F344199AB55B35D436F8A0B"><enum>(ii)</enum><text>the Food and Drug Administration.</text> </clause></subparagraph></paragraph><paragraph id="idDD1CDB13999946718DD4FF02445A1AF9"><enum>(3)</enum><header>Director</header><text>The term <quote>Director</quote> means the Director of the Office of Government Ethics.</text> </paragraph><paragraph id="id6CD7A31D43E848B4B5930599633CC6FF"><enum>(4)</enum><header>Former client</header><text>The term <quote>former client</quote>—</text> <subparagraph id="id423523FF84A446F6B7592F08866EE53C"><enum>(A)</enum><text>means a person for whom the covered pharmaceutical regulator served personally as an agent, attorney, or consultant during the 2-year period ending on the date (after such service) on which the covered pharmaceutical regulator begins service in the Federal Government; and</text> </subparagraph><subparagraph id="id3A213BED30F0484D9B8EB9F4C049336C"><enum>(B)</enum><text>does not include—</text> <clause id="id4D65C07F757545CC81CED19C0213D67D"><enum>(i)</enum><text>instances in which the service provided was limited to a speech or similar appearance; or</text> </clause><clause id="id7AF9210331E44559BE378263C234D8AA"><enum>(ii)</enum><text>a client of the former employer of the covered pharmaceutical regulator to whom the covered pharmaceutical regulator did not personally provide such services.</text> </clause></subparagraph></paragraph><paragraph id="idfc8d0e8c2cf74326a38a6475d370dd40"><enum>(5)</enum><header>Former employer</header><text>The term <quote>former employer</quote>—</text> <subparagraph id="id4DA9236A001A403CBBD577F15C3D2BD2"><enum>(A)</enum><text>means a person for whom a covered pharmaceutical regulator served as an employee, officer, director, trustee, or general partner during the 2-year period ending on the date (after such service) on which the covered pharmaceutical regulator begins service in the Federal Government; and</text> </subparagraph><subparagraph id="idAA171422515844D18B633D13A83B4664"><enum>(B)</enum><text>does not include—</text> <clause id="idD5F9A97E6C4C4BA9BC4B041D4FBD8767"><enum>(i)</enum><text>any entity in the Federal Government, including an executive branch agency;</text> </clause><clause id="id565E03D70FC04A7BB93654D7FFEFB4A7"><enum>(ii)</enum><text>a State or local government;</text> </clause><clause id="idB44D35D531F34087BC7634CFC3EE5BB5"><enum>(iii)</enum><text>the District of Columbia;</text> </clause><clause id="id50905B09984D4CE3B453129A76E5A4AC"><enum>(iv)</enum><text>an Indian tribe, as defined in section 4 of the Indian Self-Determination and Education Assistance Act (<external-xref legal-doc="usc" parsable-cite="usc/25/5304">25 U.S.C. 5304</external-xref>); or</text> </clause><clause id="id98124507F0914E5FAB6843B9290001F7"><enum>(v)</enum><text>the government of a territory or possession of the United States.</text> </clause></subparagraph></paragraph></subsection></section><section id="id30F44DA2B30B4CCDB0E5A43CC9E1DCA7"><enum>602.</enum><header>Conflict of interest and eligibility standards for pharmaceutical regulators</header> <subsection id="id81bc1e8866e74a009530036ed313a83d"><enum>(a)</enum><header>In general</header><text>A covered pharmaceutical regulator shall not make, participate in making, 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 regulator.</text> </subsection><subsection id="id9e5e9fbb64ae4a36ba3e95e352e1ee87"><enum>(b)</enum><header>Recusal</header><text>A covered pharmaceutical regulator shall recuse himself or herself from any official action that would violate subsection (a).</text> </subsection><subsection id="idd64991de2b4840109cdd43bcf5fea55f"><enum>(c)</enum><header>Waiver</header> <paragraph id="id72221AF95E864AE29858C67870358D22"><enum>(1)</enum><header>In general</header><text>The head of the covered pharmaceutical regulatory agency employing a covered pharmaceutical regulator, in consultation with the Director, may grant a written waiver of the restrictions under subsection (a) if, and to the extent that, the head of the covered pharmaceutical regulatory agency certifies in writing that—</text> <subparagraph id="id9b5645dcb5464965acd6a0b1102f94b8"><enum>(A)</enum><text>the application of the restriction to the particular matter is inconsistent with the purposes of the restriction; or</text> </subparagraph><subparagraph id="id3fe62e21a0c747c9a019d7cd36ff3c27"><enum>(B)</enum><text>it is in the public interest to grant the waiver.</text> </subparagraph></paragraph><paragraph id="id42ea63e008794a48ad699bd17d9ae0af"><enum>(2)</enum><header>Publication</header><text display-inline="yes-display-inline">The Director shall make each waiver under paragraph (1) publicly available on the Web site of the Office of Government Ethics.</text> </paragraph></subsection></section><section id="idDFEF56A19AA84A228F0BB9D84646EDFB"><enum>603.</enum><header>Negotiating future private sector employment</header> <subsection id="ida627bb9ba1ba40ec996677fb0503dc1a"><enum>(a)</enum><header>Prohibition</header><text>Except as provided in subsection (c), and notwithstanding any other provision of law, a covered pharmaceutical regulator may not participate in any particular matter which involves, to the knowledge of the covered pharmaceutical regulator, an individual or entity with whom the covered pharmaceutical regulator is in negotiations of future employment or has an arrangement concerning prospective employment.</text> </subsection><subsection id="ida9744e3db05f4dd99b0c577c8b97517b"><enum>(b)</enum><header>Disclosure of employment negotiations</header> <paragraph id="idBEEAE0C67D774BD0A1CA1612752FBD1B"><enum>(1)</enum><header>In general</header><text>If a covered pharmaceutical regulator begins any negotiations of future employment with another person, or an agent or intermediary of another person, or other discussion or communication with another person, or an agent or intermediary of another person, mutually conducted with a view toward reaching an agreement regarding possible employment of the covered pharmaceutical regulator, the covered pharmaceutical regulator shall notify the designated agency ethics official of the covered pharmaceutical regulatory agency employing the covered pharmaceutical regulator regarding the negotiations, discussions, or communications.</text> </paragraph><paragraph id="id471DD4A693684A27BD257B9D91EBD203"><enum>(2)</enum><header>Information</header><text>A designated agency ethics official receiving notice under paragraph (1), after consultation with the Director, shall inform the covered pharmaceutical regulator of any potential conflicts of interest involved in any negotiations, discussions, or communications with the other person and the applicable prohibitions.</text> </paragraph><paragraph id="id408B1E5427034CD5896AD09BFB1C7C29"><enum>(3)</enum><header>Publication</header><text>The Director, after receiving notice under paragraph (1), 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 regulator.</text> </paragraph></subsection><subsection id="id2a81e6ab8036416e9e837fd9b3f98416"><enum>(c)</enum><header>Waivers only when exceptional circumstances exist</header> <paragraph id="idB5F77F21737545A2ABB9B876F93D35E1"><enum>(1)</enum><header>In general</header><text>The head of a covered pharmaceutical regulatory agency may only grant a waiver of the prohibition under subsection (a) if the head determines that exceptional circumstances exist.</text> </paragraph><paragraph id="id13A4075C17D3432490387DFBDA44B672"><enum>(2)</enum><header>Review and publication</header><text>For any waiver granted under paragraph (1), the Director shall—</text> <subparagraph id="id6111B22265AE4A979EAC1CF797C9BADC"><enum>(A)</enum><text>review the circumstances relating to the waiver and the determination that exceptional circumstances exist; and</text> </subparagraph><subparagraph id="id9CEF3ECEFA2749FD8D19E3834A2BEA53"><enum>(B)</enum><text>make the waiver publicly available on the Web site of the Office of Government Ethics, which shall include—</text> <clause id="id8D6FFFA806C94F3F90D5F2E6B7DB9DBF"><enum>(i)</enum><text>the name of the private person involved in the negotiations or arrangement concerning prospective employment of the covered pharmaceutical regulator; and</text> </clause><clause id="idC32BF77119A344BA841D39AF22E70156"><enum>(ii)</enum><text>the date on which the negotiations or arrangement commenced.</text> </clause></subparagraph></paragraph></subsection><subsection id="id3EF0D03DD2A142048F1EE363C7AEF36E"><enum>(d)</enum><header>Scope</header><text>For the purposes of this section, the term <term>negotiations of future employment</term> is not limited to discussions of specific terms or conditions of employment in a specific position.</text> </subsection></section><section id="id1A1E24CA92CF4AD0A33376B56BE01350"><enum>604.</enum><header>Recordkeeping</header><text display-inline="no-display-inline">The Director shall—</text> <paragraph id="id0bd67e67fb334d7bb60fe612a111e3dc"><enum>(1)</enum><text>receive all employment histories, recusal and waiver records, and other disclosure records for covered pharmaceutical regulators necessary for monitoring compliance with this title, and make those records publicly available on the Web site of the Office of Government Ethics;</text> </paragraph><paragraph id="id5d903d1717624df7a5aa37c0b060be09"><enum>(2)</enum><text>promulgate rules and regulations, in consultation with the Director of the Office of Personnel Management and the Attorney General, to implement this title;</text> </paragraph><paragraph id="ida700e3b61b5648c6a4e5782003b5a41e"><enum>(3)</enum><text>provide guidance and assistance where appropriate to facilitate compliance with this title;</text> </paragraph><paragraph id="idd84c178039ce471fb8af65979042a2f7"><enum>(4)</enum><text>review and, where necessary, assist designated agency ethics officials in providing advice to covered pharmaceutical regulators regarding compliance with this title; and</text> </paragraph><paragraph id="id5ecb9b666b8e49dc97a2374e5da18d78"><enum>(5)</enum><text>if the Director determines that a violation of this title may have occurred, and in consultation with the designated agency ethics official and the Counsel to the President, refer the compliance case to the United States Attorney for the District of Columbia for enforcement action.</text> </paragraph></section><section id="id0347DB868AC843E4B288D7C09FEAD5EC"><enum>605.</enum><header>Penalties and injunctions</header> <subsection id="id0c26d44a968f45b4a335aa69ddacceb7"><enum>(a)</enum><header>Criminal penalties</header> <paragraph id="idDE9B5ED286274233BCCD9F97E36B9A29"><enum>(1)</enum><header>In general</header><text>Any person who violates section 602 or 603 shall be fined under title 18, United States Code, imprisoned for not more than 1 year, or both.</text> </paragraph><paragraph id="idc1416cb9eca540e086ff67688b330af9"><enum>(2)</enum><header>Willful violations</header><text>Any person who willfully violates section 602 or 603 shall be fined under title 18, United States Code, imprisoned for not more than 5 years, or both.</text> </paragraph></subsection><subsection id="id8f0283d638464468a461dcb732c099a7"><enum>(b)</enum><header>Civil enforcement</header> <paragraph id="idC2F3C6C2F2094647905EB89AAF4FED26"><enum>(1)</enum><header>In general</header><text>The Attorney General may bring a civil action in an appropriate district court of the United States against any person who violates, or whom the Attorney General has reason to believe is engaging in conduct that violates, section 602 or 603.</text> </paragraph><paragraph id="idACD6AD98FE9B4E4D87466148C0095D4B"><enum>(2)</enum><header>Civil penalty</header> <subparagraph id="id7CC6C30FF9414701B4F4053186F9FCB1"><enum>(A)</enum><header>In general</header><text>Upon proof by a preponderance of the evidence that a person violated section 602 or 603, the court shall impose a civil penalty of not more than the greater of—</text> <clause id="id14BC668F0CEF47ED8FD80537DBB06F9C"><enum>(i)</enum><text>$100,000 for each violation; or</text> </clause><clause id="id306B4CD675E240C5AD910424985A4B3E"><enum>(ii)</enum><text>the amount of compensation the person received or was offered for the conduct constituting the violation.</text> </clause></subparagraph><subparagraph id="idAD77B72215344E78BCD47B1BA7A9FDD5"><enum>(B)</enum><header>Rule of construction</header><text>A civil penalty under this subsection shall be in addition to any other criminal or civil statutory, common law, or administrative remedy available to the United States or any other person.</text> </subparagraph></paragraph><paragraph id="id25abd7595dbd44b49e1c091ba7eb5a14"><enum>(3)</enum><header>Injunctive relief</header> <subparagraph id="id69E734434DDF4D6B9EA644C0936B66FD"><enum>(A)</enum><header>In general</header><text>In a civil action brought under paragraph (1) against a person, the Attorney General may petition the court for an order prohibiting the person from engaging in conduct that violates section 602 or 603.</text> </subparagraph><subparagraph id="idA7AD0F37B5DE4C83A71AA962F5F65185"><enum>(B)</enum><header>Standard</header><text>The court may issue an order under subparagraph (A) if the court finds by a preponderance of the evidence that the conduct of the person violates section 602 or 603.</text> </subparagraph><subparagraph id="idB13232CA1C9A442F883FF424B95B95F0"><enum>(C)</enum><header>Rule of construction</header><text>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 person.</text></subparagraph></paragraph></subsection></section>.
3.
Slowing the revolving door from pharmaceutical regulatory agency into private sector representational activities
(a)
In general
Section 207 of title 18, United States Code, is amended— (1)by redesignating subsections (e) through (l) as subsections (f) through (m), respectively; and (2)by inserting after subsection (d) the following: (e)
Restrictions on employment for pharmaceutical regulators
(1)
In general
In addition to the restrictions set forth in subsections (a), (b), (c), and (d), a covered pharmaceutical regulator shall not— (A)during the 2-year period beginning on the date on which his or her employment as a covered pharmaceutical regulator ceases— (i)knowingly act as agent or attorney for, or otherwise represent, any other person for compensation (except the United States) in any formal or informal appearance before; (ii)with the intent to influence, make any oral or written communication on behalf of any other person (except the United States) to; or (iii)knowingly aid, advise, or assist in— (I)representing any other person (except the United States) in any formal or informal appearance before; or (II)making, with the intent to influence, any oral or written communication on behalf of any other person (except the United States) to, any court of the United States, or any officer or employee thereof, in connection with any judicial or other proceeding, which was actually pending under his or her official responsibility as a covered pharmaceutical regulator during the 1-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 regulator; or(B)during the 2-year period beginning on the date on which his or her employment as a covered pharmaceutical regulator ceases— (i)knowingly act as a lobbyist or agent for, or otherwise represent, any other person for compensation (except the United States) in any formal or informal appearance before; (ii)with the intent to influence, make any oral or written communication or conduct any lobbying activities on behalf of any other person (except the United States) to; or (iii)knowingly aid, advise, or assist in— (I)representing any other person (except the United States) in any formal or informal appearance before; or (II)making, with the intent to influence, any oral or written communication or conduct any lobbying activities on behalf of any other person (except the United States) to, any department or agency of the executive branch or Congress (including any committee of Congress), or any officer or employee thereof, in connection with any matter that is pending before the department, the agency, or Congress.(2)
Penalty
Any person who violates paragraph (1) shall be punished as provided in section 216. (3)
Definitions
In this subsection— (A)the term covered pharmaceutical regulator has the meaning given that term in section 601 of the Ethics in Government Act of 1978 (5 U.S.C. App.); and (B)the terms lobbying activities and lobbyist have the meanings given those terms in section 3 of the Lobbying Disclosure Act of 1995 (2 U.S.C. 1602).. (b)
Technical and conforming amendments
(1)Section 103(a) of the Honest Leadership and Open Government Act of 2007 (2 U.S.C. 4702(a)) is amended by striking section 207(e) each place it appears and inserting section 207(f). (2)Section 207 of title 18, United States Code, as amended by subsection (a), is amended— (A)in subsection (g)(1), as so redesignated, by striking or (e) and inserting or (f); (B)in subsection (j)(1)(B), as so redesignated, by striking subsection (f) and inserting subsection (g); and (C)in subsection (k), as so redesignated— (i)in paragraph (1)(B), by striking (25 U.S.C. 450i(j)) and inserting (25 U.S.C. 5323(j)); (ii)in paragraph (2), in the matter preceding subparagraph (A), by striking and (e) and inserting (e), and (f); (iii)in paragraph (4), by striking and (e) and inserting (e), and (f); and (iv)in paragraph (7)— (I)in subparagraph (A), by striking and (e) and inserting (e), and (f); and (II)in subparagraph (B)(ii), in the matter preceding subclause (I), by striking subsections (c), (d), or (e) and inserting subsection (c), (d), (e), or (f). (3)Section 141(b)(4) of the Trade Act of 1974 (19 U.S.C. 2171(b)(4)) is amended by striking section 207(f)(3) and inserting 207(g)(3). (4)Section 7802(b)(3)(B) of the Internal Revenue Code of 1986 is amended by striking and (f) of section 207 and inserting and (g) of section 207. (5)Section 3105(c) of the USEC Privatization Act (42 U.S.C. 2297h–3(c)) is amended by striking and (d) and inserting (d), and (e). (6)Section 106(p)(6)(I)(ii) of title 49, United States Code, is amended by striking and (f) of section 207 and inserting and (g) of section 207.
4.
Severability
If any provision of this Act or any amendment made by this Act, or any application of such provision or amendment to any person or circumstance, is held to be unconstitutional, 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 affected.