II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Pharmaceutical Regu5 lation Conflict of Interest Act’’. 


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1 SEC. 2. REQUIREMENTS RELATING TO SLOWING THE RE2 VOLVING DOOR AMONG PHARMACEUTICAL 

3 REGULATORS. 

4 The Ethics in Government Act of 1978 (5 U.S.C. 

5 App.) is amended by adding at the end the following: 

6 ‘‘TITLE VI—SPECIAL REQUIRE7 MENTS FOR PHARMA8 CEUTICAL REGULATORS 

9 ‘‘SEC. 601. DEFINITIONS. 

10 ‘‘(a) IN GENERAL.—In this title, the terms ‘des11 ignated agency ethics official’ and ‘executive branch’ have 

12 the meanings given those terms under section 109. 

13 ‘‘(b) OTHER DEFINITIONS.—In this title: 

14 ‘‘(1) COVERED PHARMACEUTICAL REGU15 LATOR.—The term ‘covered pharmaceutical regu16 lator’ means an officer or employee of a covered 

17 pharmaceutical regulatory agency who occupies— 

18 ‘‘(A) a supervisory position classified at or 

19 above GS–13 of the General Schedule; 

20 ‘‘(B) in the case of a position not under 

21 the General Schedule, a supervisory position for 

22 which the rate of basic pay is not less than the 

23 minimum rate of basic pay for GS–13 of the 

24 General Schedule; or 


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1 ‘‘(C) any other supervisory position deter2 mined to be of equal classification by the Direc3 tor. 

4 ‘‘(2) COVERED PHARMACEUTICAL REGULATORY

5 AGENCY.—The term ‘covered pharmaceutical regu6 latory agency’— 

7 ‘‘(A) means an agency whose primary re8 sponsibility is to regulate the manufacture, dis9 tribution, or sale of drugs (as defined in section 

10 201 of the Federal Food, Drug, and Cosmetic 

11 Act (21 U.S.C. 321)) or biological products (as 

12 defined in section 351 of the Public Health 

13 Service Act (42 U.S.C. 262)); and 

14 ‘‘(B) includes— 

15 ‘‘(i) the Drug Enforcement Adminis16 tration; and 

17 ‘‘(ii) the Food and Drug Administra18 tion. 

19 ‘‘(3) DIRECTOR.—The term ‘Director’ means 

20 the Director of the Office of Government Ethics. 

21 ‘‘(4) FORMER CLIENT.—The term ‘former cli22 ent’— 

23 ‘‘(A) means a person for whom the covered 

24 pharmaceutical regulator served personally as 

25 an agent, attorney, or consultant during the 2- 


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1 year period ending on the date (after such serv2 ice) on which the covered pharmaceutical regu3 lator begins service in the Federal Government; 

4 and 

5 ‘‘(B) does not include— 

6 ‘‘(i) instances in which the service 

7 provided was limited to a speech or similar 

8 appearance; or 

9 ‘‘(ii) a client of the former employer 

10 of the covered pharmaceutical regulator to 

11 whom the covered pharmaceutical regu12 lator did not personally provide such serv13 ices. 

14 ‘‘(5) FORMER EMPLOYER.—The term ‘former 

15 employer’— 

16 ‘‘(A) means a person for whom a covered 

17 pharmaceutical regulator served as an em18 ployee, officer, director, trustee, or general part19 ner during the 2-year period ending on the date 

20 (after such service) on which the covered phar21 maceutical regulator begins service in the Fed22 eral Government; and 

23 ‘‘(B) does not include— 


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1 ‘‘(i) any entity in the Federal Govern2 ment, including an executive branch agen3 cy; 

4 ‘‘(ii) a State or local government; 

5 ‘‘(iii) the District of Columbia; 

6 ‘‘(iv) an Indian tribe, as defined in 

7 section 4 of the Indian Self-Determination 

8 and Education Assistance Act (25 U.S.C. 

9 5304); or 

10 ‘‘(v) the government of a territory or 

11 possession of the United States. 

12 ‘‘SEC. 602. CONFLICT OF INTEREST AND ELIGIBILITY 

13 STANDARDS FOR PHARMACEUTICAL REGU14 LATORS. 

15 ‘‘(a) IN GENERAL.—A covered pharmaceutical regu16 lator shall not make, participate in making, or in any way 

17 attempt to use the official position of the covered pharma18 ceutical regulator to influence a particular matter that 

19 provides a direct and substantial pecuniary benefit for a 

20 former employer or former client of the covered pharma21 ceutical regulator. 

22 ‘‘(b) RECUSAL.—A covered pharmaceutical regulator 

23 shall recuse himself or herself from any official action that 

24 would violate subsection (a). 

25 ‘‘(c) WAIVER.— 


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1 ‘‘(1) IN GENERAL.—The head of the covered 

2 pharmaceutical regulatory agency employing a cov3 ered pharmaceutical regulator, in consultation with 

4 the Director, may grant a written waiver of the re5 strictions under subsection (a) if, and to the extent 

6 that, the head of the covered pharmaceutical regu7 latory agency certifies in writing that— 

8 ‘‘(A) the application of the restriction to 

9 the particular matter is inconsistent with the 

10 purposes of the restriction; or 

11 ‘‘(B) it is in the public interest to grant 

12 the waiver. 

13 ‘‘(2) PUBLICATION.—The Director shall make 

14 each waiver under paragraph (1) publicly available 

15 on the Web site of the Office of Government Ethics. 

16 ‘‘SEC. 603. NEGOTIATING FUTURE PRIVATE SECTOR EM17 PLOYMENT. 

18 ‘‘(a) PROHIBITION.—Except as provided in sub19 section (c), and notwithstanding any other provision of 

20 law, a covered pharmaceutical regulator may not partici21 pate in any particular matter which involves, to the knowl22 edge of the covered pharmaceutical regulator, an indi23 vidual or entity with whom the covered pharmaceutical 

24 regulator is in negotiations of future employment or has 

25 an arrangement concerning prospective employment. 


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1 ‘‘(b) DISCLOSURE OF EMPLOYMENT NEGOTIA2 TIONS.— 

3 ‘‘(1) IN GENERAL.—If a covered pharmaceutical 

4 regulator begins any negotiations of future employ5 ment with another person, or an agent or inter6 mediary of another person, or other discussion or 

7 communication with another person, or an agent or 

8 intermediary of another person, mutually conducted 

9 with a view toward reaching an agreement regarding 

10 possible employment of the covered pharmaceutical 

11 regulator, the covered pharmaceutical regulator shall 

12 notify the designated agency ethics official of the 

13 covered pharmaceutical regulatory agency employing 

14 the covered pharmaceutical regulator regarding the 

15 negotiations, discussions, or communications. 

16 ‘‘(2) INFORMATION.—A designated agency eth17 ics official receiving notice under paragraph (1), 

18 after consultation with the Director, shall inform the 

19 covered pharmaceutical regulator of any potential 

20 conflicts of interest involved in any negotiations, dis21 cussions, or communications with the other person 

22 and the applicable prohibitions. 

23 ‘‘(3) PUBLICATION.—The Director, after receiv24 ing notice under paragraph (1), shall make publicly 

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1 ment Ethics the name of the covered pharmaceutical 

2 regulator and the name of the private person in3 volved in the negotiations or arrangement con4 cerning prospective employment of the covered phar5 maceutical regulator. 

6 ‘‘(c) WAIVERS ONLY WHEN EXCEPTIONAL CIR7 CUMSTANCES EXIST.— 

8 ‘‘(1) IN GENERAL.—The head of a covered 

9 pharmaceutical regulatory agency may only grant a 

10 waiver of the prohibition under subsection (a) if the 

11 head determines that exceptional circumstances 

12 exist. 

13 ‘‘(2) REVIEW AND PUBLICATION.—For any 

14 waiver granted under paragraph (1), the Director 

15 shall— 

16 ‘‘(A) review the circumstances relating to 

17 the waiver and the determination that excep18 tional circumstances exist; and 

19 ‘‘(B) make the waiver publicly available on 

20 the Web site of the Office of Government Eth21 ics, which shall include— 

22 ‘‘(i) the name of the private person in23 volved in the negotiations or arrangement 

24 concerning prospective employment of the 

25 covered pharmaceutical regulator; and 


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1 ‘‘(ii) the date on which the negotia2 tions or arrangement commenced. 

3 ‘‘(d) SCOPE.—For the purposes of this section, the 

4 term ‘negotiations of future employment’ is not limited to 

5 discussions of specific terms or conditions of employment 

6 in a specific position. 

7 ‘‘SEC. 604. RECORDKEEPING. 

8 ‘‘The Director shall— 

9 ‘‘(1) receive all employment histories, recusal 

10 and waiver records, and other disclosure records for 

11 covered pharmaceutical regulators necessary for 

12 monitoring compliance with this title, and make 

13 those records publicly available on the Web site of 

14 the Office of Government Ethics; 

15 ‘‘(2) promulgate rules and regulations, in con16 sultation with the Director of the Office of Per17 sonnel Management and the Attorney General, to 

18 implement this title; 

19 ‘‘(3) provide guidance and assistance where ap20 propriate to facilitate compliance with this title; 

21 ‘‘(4) review and, where necessary, assist des22 ignated agency ethics officials in providing advice to 

23 covered pharmaceutical regulators regarding compli24 ance with this title; and 


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1 ‘‘(5) if the Director determines that a violation 

2 of this title may have occurred, and in consultation 

3 with the designated agency ethics official and the 

4 Counsel to the President, refer the compliance case 

5 to the United States Attorney for the District of Co6 lumbia for enforcement action. 

7 ‘‘SEC. 605. PENALTIES AND INJUNCTIONS. 

8 ‘‘(a) CRIMINAL PENALTIES.— 

9 ‘‘(1) IN GENERAL.—Any person who violates 

10 section 602 or 603 shall be fined under title 18, 

11 United States Code, imprisoned for not more than 

12 1 year, or both. 

13 ‘‘(2) WILLFUL VIOLATIONS.—Any person who 

14 willfully violates section 602 or 603 shall be fined 

15 under title 18, United States Code, imprisoned for 

16 not more than 5 years, or both. 

17 ‘‘(b) CIVIL ENFORCEMENT.— 

18 ‘‘(1) IN GENERAL.—The Attorney General may 

19 bring a civil action in an appropriate district court 

20 of the United States against any person who vio21 lates, or whom the Attorney General has reason to 

22 believe is engaging in conduct that violates, section 

23 602 or 603. 

24 ‘‘(2) CIVIL PENALTY.— 


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1 ‘‘(A) IN GENERAL.—Upon proof by a pre2 ponderance of the evidence that a person vio3 lated section 602 or 603, the court shall impose 

4 a civil penalty of not more than the greater 

5 of— 

6 ‘‘(i) $100,000 for each violation; or 

7 ‘‘(ii) the amount of compensation the 

8 person received or was offered for the con9 duct constituting the violation. 

10 ‘‘(B) RULE OF CONSTRUCTION.—A civil 

11 penalty under this subsection shall be in addi12 tion to any other criminal or civil statutory, 

13 common law, or administrative remedy available 

14 to the United States or any other person. 

15 ‘‘(3) INJUNCTIVE RELIEF.— 

16 ‘‘(A) IN GENERAL.—In a civil action 

17 brought under paragraph (1) against a person, 

18 the Attorney General may petition the court for 

19 an order prohibiting the person from engaging 

20 in conduct that violates section 602 or 603. 

21 ‘‘(B) STANDARD.—The court may issue an 

22 order under subparagraph (A) if the court finds 

23 by a preponderance of the evidence that the 

24 conduct of the person violates section 602 or 

25 603. 


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1 ‘‘(C) RULE OF CONSTRUCTION.—The filing 

2 of a petition seeking injunctive relief under this 

3 paragraph shall not preclude any other remedy 

4 that is available by law to the United States or 

5 any other person.’’. 

6 SEC. 3. SLOWING THE REVOLVING DOOR FROM PHARMA7 CEUTICAL REGULATORY AGENCY INTO PRI8 VATE SECTOR REPRESENTATIONAL ACTIVI9 TIES. 

10 (a) IN GENERAL.—Section 207 of title 18, United 

11 States Code, is amended— 

12 (1) by redesignating subsections (e) through (l) 

13 as subsections (f) through (m), respectively; and 

14 (2) by inserting after subsection (d) the fol15 lowing: 

16 ‘‘(e) RESTRICTIONS ON EMPLOYMENT FOR PHARMA17 CEUTICAL REGULATORS.— 

18 ‘‘(1) IN GENERAL.—In addition to the restric19 tions set forth in subsections (a), (b), (c), and (d), 

20 a covered pharmaceutical regulator shall not— 

21 ‘‘(A) during the 2-year period beginning on 

22 the date on which his or her employment as a 

23 covered pharmaceutical regulator ceases— 

24 ‘‘(i) knowingly act as agent or attor25 ney for, or otherwise represent, any other 


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1 person for compensation (except the 

2 United States) in any formal or informal 

3 appearance before; 

4 ‘‘(ii) with the intent to influence, 

5 make any oral or written communication 

6 on behalf of any other person (except the 

7 United States) to; or 

8 ‘‘(iii) knowingly aid, advise, or assist 

9 in— 

10 ‘‘(I) representing any other per11 son (except the United States) in any 

12 formal or informal appearance before; 

13 or 

14 ‘‘(II) making, with the intent to 

15 influence, any oral or written commu16 nication on behalf of any other person 

17 (except the United States) to, 

18 any court of the United States, or any offi19 cer or employee thereof, in connection with 

20 any judicial or other proceeding, which was 

21 actually pending under his or her official 

22 responsibility as a covered pharmaceutical 

23 regulator during the 1-year period ending 

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1 lator ceases or in which he or she partici2 pated personally and substantially as a 

3 covered pharmaceutical regulator; or 

4 ‘‘(B) during the 2-year period beginning on 

5 the date on which his or her employment as a 

6 covered pharmaceutical regulator ceases— 

7 ‘‘(i) knowingly act as a lobbyist or 

8 agent for, or otherwise represent, any 

9 other person for compensation (except the 

10 United States) in any formal or informal 

11 appearance before; 

12 ‘‘(ii) with the intent to influence, 

13 make any oral or written communication 

14 or conduct any lobbying activities on behalf 

15 of any other person (except the United 

16 States) to; or 

17 ‘‘(iii) knowingly aid, advise, or assist 

18 in— 

19 ‘‘(I) representing any other per20 son (except the United States) in any 

21 formal or informal appearance before; 

22 or 

23 ‘‘(II) making, with the intent to 

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1 tivities on behalf of any other person 

2 (except the United States) to, 

3 any department or agency of the executive 

4 branch or Congress (including any com5 mittee of Congress), or any officer or em6 ployee thereof, in connection with any mat7 ter that is pending before the department, 

8 the agency, or Congress. 

9 ‘‘(2) PENALTY.—Any person who violates para10 graph (1) shall be punished as provided in section 

11 216. 

12 ‘‘(3) DEFINITIONS.—In this subsection— 

13 ‘‘(A) the term ‘covered pharmaceutical reg14 ulator’ has the meaning given that term in sec15 tion 601 of the Ethics in Government Act of 

16 1978 (5 U.S.C. App.); and 

17 ‘‘(B) the terms ‘lobbying activities’ and 

18 ‘lobbyist’ have the meanings given those terms 

19 in section 3 of the Lobbying Disclosure Act of 

20 1995 (2 U.S.C. 1602).’’. 

21 (b) TECHNICAL AND CONFORMING AMENDMENTS.— 

22 (1) Section 103(a) of the Honest Leadership 

23 and Open Government Act of 2007 (2 U.S.C. 

24 4702(a)) is amended by striking ‘‘section 207(e)’’ 

25 each place it appears and inserting ‘‘section 207(f)’’. 


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1 (2) Section 207 of title 18, United States Code, 

2 as amended by subsection (a), is amended— 

3 (A) in subsection (g)(1), as so redesig4 nated, by striking ‘‘or (e)’’ and inserting ‘‘or 

5 (f)’’; 

6 (B) in subsection (j)(1)(B), as so redesig7 nated, by striking ‘‘subsection (f)’’ and insert8 ing ‘‘subsection (g)’’; and 

9 (C) in subsection (k), as so redesignated— 

10 (i) in paragraph (1)(B), by striking 

11 ‘‘(25 U.S.C. 450i(j))’’ and inserting ‘‘(25 

12 U.S.C. 5323(j))’’; 

13 (ii) in paragraph (2), in the matter 

14 preceding subparagraph (A), by striking 

15 ‘‘and (e)’’ and inserting ‘‘(e), and (f)’’; 

16 (iii) in paragraph (4), by striking 

17 ‘‘and (e)’’ and inserting ‘‘(e), and (f)’’; and 

18 (iv) in paragraph (7)— 

19 (I) in subparagraph (A), by strik20 ing ‘‘and (e)’’ and inserting ‘‘(e), and 

21 (f)’’; and 

22 (II) in subparagraph (B)(ii), in 

23 the matter preceding subclause (I), by 

24 striking ‘‘subsections (c), (d), or (e)’’ 


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1 and inserting ‘‘subsection (c), (d), (e), 

2 or (f)’’. 

3 (3) Section 141(b)(4) of the Trade Act of 1974 

4 (19 U.S.C. 2171(b)(4)) is amended by striking ‘‘sec5 tion 207(f)(3)’’ and inserting ‘‘207(g)(3)’’. 

6 (4) Section 7802(b)(3)(B) of the Internal Rev7 enue Code of 1986 is amended by striking ‘‘and (f) 

8 of section 207’’ and inserting ‘‘and (g) of section 

9 207’’. 

10 (5) Section 3105(c) of the USEC Privatization 

11 Act (42 U.S.C. 2297h–3(c)) is amended by striking 

12 ‘‘and (d)’’ and inserting ‘‘(d), and (e)’’. 

13 (6) Section 106(p)(6)(I)(ii) of title 49, United 

14 States Code, is amended by striking ‘‘and (f) of sec15 tion 207’’ and inserting ‘‘and (g) of section 207’’. 

16 SEC. 4. SEVERABILITY. 

17 If any provision of this Act or any amendment made 

18 by this Act, or any application of such provision or amend19 ment to any person or circumstance, is held to be uncon20 stitutional, the remainder of the provisions of this Act and 

21 the amendments made by this Act and the application of 

22 the provision or amendment to any other person or cir23 cumstance shall not be affected. 

Æ 


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