[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>