II 

115TH CONGRESS 

2D SESSION S. 2691 

To hold pharmaceutical companies accountable for illegal marketing and distribution of opioid products and for their role in creating and exacerbating the opioid epidemic in the United States. 

IN THE SENATE OF THE UNITED STATES 

APRIL 17, 2018 

Mr. SANDERS (for himself and Ms. HARRIS) introduced the following bill; 

which was read twice and referred to the Committee on Finance 

A BILL 

To hold pharmaceutical companies accountable for illegal 

marketing and distribution of opioid products and for 

their role in creating and exacerbating the opioid epidemic in the United States. 

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 ‘‘Opioid Crisis Account5 ability Act of 2018’’. 


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1 SEC. 2. PROHIBITION OF ILLEGAL MARKETING AND DIS2 TRIBUTION PRACTICES WITH RESPECT TO 

3 OPIOIDS. 

4 (a) IN GENERAL.—Section 303 of the Federal Food, 

5 Drug, and Cosmetic Act (21 U.S.C. 333) is amended by 

6 adding at the end the following: 

7 ‘‘(h)(1) In this subsection, the term ‘illegal marketing 

8 or distribution practice with respect to an opioid’ means— 

9 ‘‘(A) including in any advertisement, promotion, 

10 direct-to-consumer marketing materials, or other 

11 marketing material a representation that an opioid 

12 has no addiction-forming or addiction-sustaining li13 ability or has less of an addiction-forming or addic14 tion-sustaining liability than one or more other 

15 opioids, knowing the representation to be false, as 

16 determined by the Secretary, in consultation with 

17 the Commissioner, based on research, testimonials, 

18 and other evidence; 

19 ‘‘(B) supplying States or communities with a 

20 quantity of opioids that is not medically reasonable, 

21 as determined by the Secretary, in consultation with 

22 the Attorney General using, if applicable, data from 

23 the Automated Reports and Consolidated Ordering 

24 System of the Department of Justice; or 

25 ‘‘(C) failing to report to the Secretary any 

26 order or pattern of orders for the distribution of 


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1 opioids that would cause a reasonable person to be2 lieve the opioids were not being dispensed in a medi3 cally reasonable manner. 

4 ‘‘(2) It shall be unlawful for any person who manu5 factures or distributes an opioid to engage in an illegal 

6 marketing or distribution practice with respect to an 

7 opioid. 

8 ‘‘(3)(A) Any person who violates paragraph (2)— 

9 ‘‘(i) if a natural person employed by an opioid 

10 manufacturer or distributor, shall be— 

11 ‘‘(I) subject to a civil penalty in an amount 

12 equal to the sum of— 

13 ‘‘(aa) such person’s full amount of 

14 salary for each year during which such 

15 person engaged in illegal marketing or dis16 tribution practices with respect to an 

17 opioid product; and 

18 ‘‘(bb) the amount by which the stock 

19 or other certificates of ownership interest 

20 of the person that is owned by the indi21 vidual has increased in value during the 

22 period during which such person engaged 

23 in illegal marketing or distribution prac24 tices of an opioid product, without regard 

25 to whether the individual has sold any of 


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1 the stock or certificates from such opioid 

2 manufacturer or distributor; and 

3 ‘‘(II) with respect to a violation that occurs 

4 on or after the date of enactment of the Opioid 

5 Crisis Accountability Act of 2018, subject to 

6 the period of imprisonment specified under sec7 tion 401 of the Controlled Substances Act that 

8 would be applicable for a violation of subsection 

9 (a) of such section that involved the quantity of 

10 opioids that were involved in the illegal mar11 keting or distribution practices with respect to 

12 an opioid; 

13 ‘‘(ii) if not a natural person, shall be subject to 

14 a civil penalty in the amount equal to the sum of— 

15 ‘‘(I) $7,800,000,000; plus 

16 ‘‘(II) 25 percent of the total profit such 

17 person made on lawful sales of opioids in the 

18 United States during the period in which the 

19 person engaged in illegal marketing or distribu20 tion practices. 

21 ‘‘(B) If a person that is not a natural person 

22 violates paragraph (2), the court, without regard to 

23 the participation of such individuals in, or knowledge 

24 of such individuals of, the violation, shall— 


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1 ‘‘(i) impose on the chief executive officer 

2 (or equivalent) of the person a civil penalty in 

3 an amount equal to the sum of— 

4 ‘‘(I) the salary of the individual dur5 ing the period in which the person engaged 

6 in illegal marketing or distribution prac7 tices and such individual served as chief 

8 executive office; and 

9 ‘‘(II) the amount by which the stock 

10 or other certificates of ownership interest 

11 of the person that is owned by the indi12 vidual has increased in value during the 

13 period that the person engaged in illegal 

14 marketing or distribution practices and 

15 such individual served as chief executive 

16 officer, without regard to whether the indi17 vidual has sold any of the stock or certifi18 cates; 

19 ‘‘(ii) impose on any executive other than 

20 the chief executive officer (or equivalent) who 

21 led the finance, research, marketing, or sales 

22 department of the person a civil penalty in the 

23 amount equal to the sum of— 

24 ‘‘(I) 25 percent of the salary of the in25 dividual during the period that the person 


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1 engaged in illegal marketing or distribution 

2 practices and such individual served as 

3 such an executive; and 

4 ‘‘(II) 25 percent of the amount by 

5 which the stock or other certificates of 

6 ownership interest of the person that is 

7 owned by the individual has increased in 

8 value during the period that the person en9 gaged in illegal marketing or distribution 

10 practices and such individual served as 

11 such an executive, without regard to 

12 whether the individual has sold any of the 

13 stock or certificates; and 

14 ‘‘(iii) impose on any executive, including 

15 the chief executive officer (or equivalent) who 

16 led the finance, research, marketing, or sales 

17 department of the person during the calendar 

18 year in which a court enters a judgment that 

19 the person violated paragraph (2) and who is 

20 not subject to a civil penalty under clause (i) or 

21 (ii), a civil penalty in the amount equal to the 

22 sum of— 

23 ‘‘(I) 25 percent of the salary of the in24 dividual during the calendar year in which 

25 a court enters such judgment; and 


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1 ‘‘(II) 25 percent of the amount by 

2 which the stock or other certificates of 

3 ownership interest of the person that is 

4 owned by the individual has increased in 

5 value during the calendar year in which a 

6 court enters such judgment. 

7 ‘‘(C) Any person described in clause (i) or (ii) 

8 of subparagraph (A) shall be required to issue a 

9 public statement apologizing for their role in cre10 ating, sustaining, and exacerbating the opioid epi11 demic in the United States.’’. 

12 (b) INVESTIGATION; RETROACTIVE EFFECT.— 

13 (1) INVESTIGATION.—Immediately after the 

14 date of enactment of this Act, the Secretary of 

15 Health and Human Services, acting through the 

16 Commissioner of Food and Drugs and in consulta17 tion with the Attorney General, acting through the 

18 Administrator of the Drug Enforcement Administra19 tion, shall begin investigating all opioid manufactur20 ers and all executives employed by such manufactur21 ers to determine whether any such manufacturers or 

22 executives, at any time before or after such date of 

23 enactment, violated subsection (h)(2) of section 303 

24 of the Federal Food, Drug, and Cosmetic Act (21 

25 U.S.C. 333) (as added by subsection (a)). 


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1 (2) RETROACTIVE EFFECT.—Subsection (h)(2) 

2 of section 303 of the Federal Food, Drug, and Cos3 metic Act (21 U.S.C. 333) (as added by subsection 

4 (a)) shall take effect on January 1, 1985, and shall 

5 have retroactive effect. 

6 (c) REIMBURSEMENT OF ECONOMIC IMPACT.— 

7 (1) ESTABLISHMENT OF FUND.—There is es8 tablished in the Treasury of the United States a 

9 fund, to be known as the ‘‘Opioids Reimbursement 

10 Fund’’ (referred to in this subsection as the 

11 ‘‘Fund’’), to be administered by the Secretary of 

12 Health and Human Services (referred to in this sub13 section as the ‘‘Secretary’’), in consultation with the 

14 Commissioner of Food and Drugs. 

15 (2) TRANSFERS TO THE FUND.—In a manner 

16 consistent with section 3302(b) of title 31, United 

17 States Code, there shall be transferred to the Fund 

18 from the General Fund of the Treasury an amount 

19 equal to the amount of the civil penalties collected 

20 under subsection (h)(3) of section 303 of the Fed21 eral Food, Drug, and Cosmetic Act (21 U.S.C. 333) 

22 (as added by subsection (a)), which shall remain 

23 available until expended. 

24 (3) USE OF FUNDS.— 


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1 (A) IN GENERAL.—The Secretary, in con2 sultation with the Commissioner of Food and 

3 Drugs, may, without further appropriation, use 

4 amounts in the Fund to combat the abuse of 

5 opioids in the United States, which may include 

6 transferring amounts from the Fund to other 

7 agencies to carry out programs, projects, and 

8 activities of the agencies to combat the abuse of 

9 opioids in the United States. 

10 (B) PRIORITY.—In using amounts in the 

11 Fund, the Secretary shall give priority to pro12 viding funds for— 

13 (i) programs, projects, and activities 

14 of the Substance Abuse and Mental Health 

15 Services Administration, the Department 

16 of Labor, and the Department of Justice; 

17 (ii) programs, projects, and activities 

18 that provide services to individuals directly 

19 affected by the abuse of opioids (including 

20 family members of such individuals); 

21 (iii) programs, projects, and activities 

22 of the Department of Education related to 

23 national activities for school safety, includ24 ing such activities authorized under section 

25 4631 of the Elementary and Secondary 


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1 Education Act of 1965 (20 U.S.C. 7281) 

2 to help State and local educational agen3 cies implement evidence-based opioid-abuse 

4 prevention strategies for schools in commu5 nities impacted by the opioid crisis, and 

6 particularly for any applicant who de7 scribes how such applicant would use the 

8 funds to prevent opioid abuse by students 

9 and address the mental health needs of 

10 students affected by opioid abuse with 

11 their families or communities; and 

12 (iv) Head Start programs, including 

13 Early Head Start programs, under the 

14 Head Start Act (42 U.S.C. 9831 et seq.), 

15 to provide additional qualified child care 

16 providers trained in trauma-informed care 

17 in States with the largest number of chil18 dren and families affected by the opioid 

19 crisis in their communities. 

20 (C) AVAILABILITY.—Amounts transferred 

21 to an agency under subparagraph (A) shall re22 main available until expended. 

23 SEC. 3. REDUCED EXCLUSIVITY. 

24 (a) IN GENERAL.—If a drug manufacturer violates 

25 subsection (h)(2) of section 303 of the Federal Food, 


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1 Drug, and Cosmetic Act (21 U.S.C. 333) (as added by 

2 section 2) with respect to a covered opioid, effective on 

3 the date on which such manufacturer is found to have so 

4 violated such section— 

5 (1) any remaining period of market exclusivity 

6 with respect to such covered opioid shall be revoked; 

7 (2) the period of market exclusivity with respect 

8 to any other opioid for which such manufacturer is 

9 the holder of an approved application under section 

10 505 of the Federal Food, Drug, and Cosmetic Act 

11 (21 U.S.C. 355) or a license under section 351 of 

12 the Public Health Service Act (42 U.S.C. 262) shall 

13 be reduced to one-half of the remaining period of 

14 market exclusivity; and 

15 (3) no new or additional exclusivity shall be 

16 awarded to any opioid for which an application is 

17 submitted by such manufacturer for approval under 

18 section 505 of the Federal Food, Drug, and Cos19 metic Act (21 U.S.C. 355) or under section 351 of 

20 the Public Health Service Act (42 U.S.C. 262) or 

21 marketed as a result of product hopping. 

22 (b) DEFINITIONS.—For purposes of this section: 

23 (1) COVERED OPIOID.—A ‘‘covered opioid’’ is a 

24 prescription opioid drug, the sales of which in the 

25 United States, beginning on the date on which the 


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1 drug was first eligible to be marketed in the United 

2 States and ending on the date on which the manu3 facturer was found to be in violation of subsection 

4 (h)(2) of section 303 of the Federal Food, Drug, 

5 and Cosmetic Act (21 U.S.C. 333), has generated at 

6 least $1. 

7 (2) PERIOD OF MARKET EXCLUSIVITY.—The 

8 term ‘‘period of market exclusivity’’ with respect to 

9 a drug means the total period of market exclusivity 

10 granted under clause (ii), (iii), or (iv) of section 

11 505(c)(3)(E) of the Federal Food, Drug, and Cos12 metic Act (21 U.S.C. 355(c)(3)(E)), section 

13 505(j)(5)(B)(iv) of such Act, clause (ii), (iii), or (iv) 

14 of section 505(j)(5)(F) of such Act, section 527 of 

15 such Act, or section 351(k)(7) of the Public Health 

16 Service Act (42 U.S.C. 262(k)(7)), and any exten17 sion of such a period granted under section 505A or 

18 505E of the Federal Food, Drug, and Cosmetic Act 

19 (21 U.S.C. 355a, 355f). 

20 (3) PRODUCT HOPPING.—The term ‘‘product 

21 hopping’’ means a reformulation of an approved 

22 drug or biological product that allows a manufac23 turer to submit a new drug application under section 

24 505(b) of the Federal Food, Drug, and Cosmetic Act 

25 (21 U.S.C. 355(b)) or new application for a license 


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1 under section 351(a) of the Public Health Service 

2 Act (42 U.S.C. 262(a)) and that— 

3 (A) is intended for the treatment of the 

4 same medical condition as the drug or biological 

5 product that was originally so approved; and 

6 (B) is undertaken in conjunction with the 

7 sponsor’s actions to reduce or eliminate demand 

8 for the original formulation of the drug or bio9 logical product. 

10 SEC. 4. PENALTY WITH RESPECT TO OPIOIDS DEVELOPED 

11 USING FEDERAL FUNDING. 

12 If a drug manufacturer or distributor violates sub13 section (h)(2) of section 303 of the Federal Food, Drug, 

14 and Cosmetic Act (21 U.S.C. 333) (as added by section 

15 2) with respect to an opioid that was developed with the 

16 support of Federal funding, in addition to the applicable 

17 penalties under such subsection (h), such manufacturer or 

18 distributor shall be subject to a civil penalty in an amount 

19 equal to the sum of— 

20 (1) such Federal funding, regardless of whether 

21 the Federal funding was received by the manufac22 turer or distributor or another entity; plus 

23 (2) 25 percent of the total profit such manufac24 turer or distributor received in connection with man25 ufacturing or distributing such opioid. 


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1 SEC. 5. TREATMENT OF CERTAIN TAX CREDITS FOR VIOLA2 TORS OF ILLEGAL MARKETING AND DIS3 TRIBUTION PRACTICES WITH RESPECT TO 

4 OPIOIDS. 

5 (a) IN GENERAL.—Section 41 of the Internal Rev6 enue Code of 1986 is amended by adding at the end the 

7 following new subsection: 

8 ‘‘(i) TREATMENT OF CERTAIN TAXPAYERS VIO9 LATING ILLEGAL MARKETING AND DISTRIBUTION PRAC10 TICES WITH RESPECT TO OPIOIDS.— 

11 ‘‘(1) IN GENERAL.—In the case of any taxpayer 

12 who has engaged in an illegal marketing or distribu13 tion practice with respect to an opioid (within the 

14 meaning of section 303(h) of the Federal Food, 

15 Drug, and Cosmetic Act (21 U.S.C. 333))— 

16 ‘‘(A) no credit shall be allowed under sub17 section (a), section 45C(a), or section 3111(f) 

18 for any taxable year in the applicable period, 

19 and 

20 ‘‘(B) the taxpayer’s tax under this chapter 

21 for the taxable year described in paragraph 

22 (2)(A) shall be increased by an amount equal to 

23 the amount of credits allowed to such taxpayer 

24 by reason of subsection (a), section 45C(a), and 

25 section 3111(f) for the period described in para26 graph (2)(B). 


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1 ‘‘(2) APPLICABLE PERIOD.—For purposes of 

2 this subsection, the term ‘applicable period’ means 

3 the period of taxable years which— 

4 ‘‘(A) begins with the taxable year in which 

5 a civil penalty has been imposed for an illegal 

6 marketing or distribution practice with respect 

7 to an opioid under section 303(h)(3) of the 

8 Federal Food, Drug, and Cosmetic Act, and 

9 ‘‘(B) has a duration equal to the number 

10 of taxable years in the period that begins with 

11 the first day on which the illegal marketing or 

12 distribution practice with respect to the opioid 

13 occurred and ends on the earlier of date on 

14 which— 

15 ‘‘(i) the illegal marketing or distribu16 tion practice with respect to the opioid per17 manently ceased, or 

18 ‘‘(ii) the date on which the civil pen19 alty described in subparagraph (A) is im20 posed. 

21 For purposes of subparagraph (B), any portion of a 

22 taxable year that is less than a whole taxable year 

23 shall be treated as a whole taxable year.’’. 


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1 (b) EFFECTIVE DATE.—The amendments made by 

2 this section shall apply to taxable years ending after the 

3 date of the enactment of this Act. 

Æ 


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