Title: Pharmaceutical Regulation Conflict of Interest Act
Policy area: Government Operations and Politics

Summary:
Pharmaceutical Regulation Conflict of Interest Act
This bill amends the Ethics in Government Act of 1978 to prohibit a pharmaceutical regulator from using his or her position as regulator to influence any matter that provides a direct or substantial pecuniary benefit to a former employer or client. The position of pharmaceutical regulator refers to any officer or employee occupying a supervisory position within the Drug Enforcement Administration or the Food and Drug Administration.
The bill also prohibits such a pharmaceutical regulator from participating in matters involving an individual or entity with whom the pharmaceutical regulator is negotiating future employment.
The bill expands restrictions on lobbying by such pharmaceutical regulators following separation from employment with a pharmaceutical regulatory agency.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 2057 Introduced in Senate (IS)]

<DOC>






115th CONGRESS
  1st Session
                                S. 2057

To prevent conflicts of interest that stem from the revolving door that 
  raises concerns about the independence of pharmaceutical regulators.


_______________________________________________________________________


                   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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Pharmaceutical Regulation Conflict 
of Interest Act''.

SEC. 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:

     ``TITLE VI--SPECIAL REQUIREMENTS FOR PHARMACEUTICAL REGULATORS

``SEC. 601. DEFINITIONS.

    ``(a) In General.--In this title, the terms `designated agency 
ethics official' and `executive branch' have the meanings given those 
terms under section 109.
    ``(b) Other Definitions.--In this title:
            ``(1) Covered pharmaceutical regulator.--The term `covered 
        pharmaceutical regulator' means an officer or employee of a 
        covered pharmaceutical regulatory agency who occupies--
                    ``(A) a supervisory position classified at or above 
                GS-13 of the General Schedule;
                    ``(B) 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
                    ``(C) any other supervisory position determined to 
                be of equal classification by the Director.
            ``(2) Covered pharmaceutical regulatory agency.--The term 
        `covered pharmaceutical regulatory agency'--
                    ``(A) 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 (21 U.S.C. 321)) or 
                biological products (as defined in section 351 of the 
                Public Health Service Act (42 U.S.C. 262)); and
                    ``(B) includes--
                            ``(i) the Drug Enforcement Administration; 
                        and
                            ``(ii) the Food and Drug Administration.
            ``(3) Director.--The term `Director' means the Director of 
        the Office of Government Ethics.
            ``(4) Former client.--The term `former client'--
                    ``(A) 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
                    ``(B) does not include--
                            ``(i) instances in which the service 
                        provided was limited to a speech or similar 
                        appearance; or
                            ``(ii) a client of the former employer of 
                        the covered pharmaceutical regulator to whom 
                        the covered pharmaceutical regulator did not 
                        personally provide such services.
            ``(5) Former employer.--The term `former employer'--
                    ``(A) 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
                    ``(B) does not include--
                            ``(i) any entity in the Federal Government, 
                        including an executive branch agency;
                            ``(ii) a State or local government;
                            ``(iii) the District of Columbia;
                            ``(iv) an Indian tribe, as defined in 
                        section 4 of the Indian Self-Determination and 
                        Education Assistance Act (25 U.S.C. 5304); or
                            ``(v) the government of a territory or 
                        possession of the United States.

``SEC. 602. CONFLICT OF INTEREST AND ELIGIBILITY STANDARDS FOR 
              PHARMACEUTICAL REGULATORS.

    ``(a) In General.--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.
    ``(b) Recusal.--A covered pharmaceutical regulator shall recuse 
himself or herself from any official action that would violate 
subsection (a).
    ``(c) Waiver.--
            ``(1) In general.--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--
                    ``(A) the application of the restriction to the 
                particular matter is inconsistent with the purposes of 
                the restriction; or
                    ``(B) it is in the public interest to grant the 
                waiver.
            ``(2) Publication.--The Director shall make each waiver 
        under paragraph (1) publicly available on the Web site of the 
        Office of Government Ethics.

``SEC. 603. NEGOTIATING FUTURE PRIVATE SECTOR EMPLOYMENT.

    ``(a) Prohibition.--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.
    ``(b) Disclosure of Employment Negotiations.--
            ``(1) In general.--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.
            ``(2) Information.--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.
            ``(3) Publication.--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.
    ``(c) Waivers Only When Exceptional Circumstances Exist.--
            ``(1) In general.--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.
            ``(2) Review and publication.--For any waiver granted under 
        paragraph (1), the Director shall--
                    ``(A) review the circumstances relating to the 
                waiver and the determination that exceptional 
                circumstances exist; and
                    ``(B) make the waiver publicly available on the Web 
                site of the Office of Government Ethics, which shall 
                include--
                            ``(i) the name of the private person 
                        involved in the negotiations or arrangement 
                        concerning prospective employment of the 
                        covered pharmaceutical regulator; and
                            ``(ii) the date on which the negotiations 
                        or arrangement commenced.
    ``(d) Scope.--For the purposes of this section, the term 
`negotiations of future employment' is not limited to discussions of 
specific terms or conditions of employment in a specific position.

``SEC. 604. RECORDKEEPING.

    ``The Director shall--
            ``(1) 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;
            ``(2) promulgate rules and regulations, in consultation 
        with the Director of the Office of Personnel Management and the 
        Attorney General, to implement this title;
            ``(3) provide guidance and assistance where appropriate to 
        facilitate compliance with this title;
            ``(4) review and, where necessary, assist designated agency 
        ethics officials in providing advice to covered pharmaceutical 
        regulators regarding compliance with this title; and
            ``(5) 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.

``SEC. 605. PENALTIES AND INJUNCTIONS.

    ``(a) Criminal Penalties.--
            ``(1) In general.--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.
            ``(2) Willful violations.--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.
    ``(b) Civil Enforcement.--
            ``(1) In general.--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.
            ``(2) Civil penalty.--
                    ``(A) In general.--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--
                            ``(i) $100,000 for each violation; or
                            ``(ii) the amount of compensation the 
                        person received or was offered for the conduct 
                        constituting the violation.
                    ``(B) Rule of construction.--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.
            ``(3) Injunctive relief.--
                    ``(A) In general.--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.
                    ``(B) Standard.--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.
                    ``(C) 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 person.''.

SEC. 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''.

SEC. 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.
                                 <all>