II 

116TH CONGRESS 

1ST SESSION S. 1584 

To hold pharmaceutical companies accountable for dubious 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 

MAY 21, 2019 

Mr. SANDERS (for himself, Mr. BENNET, Ms. HARRIS, and Mr. 

BLUMENTHAL) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To hold pharmaceutical companies accountable for dubious 

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 2019’’. 


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1 SEC. 2. PROHIBITION OF DUBIOUS MARKETING AND MEDI2 CALLY UNREASONABLE DISTRIBUTION PRAC3 TICES WITH RESPECT TO OPIOIDS. 

4 (a) DUBIOUS MARKETING OR DISTRIBUTION PRAC5 TICE WITH RESPECT TO AN OPIOID.— 

6 (1) IN GENERAL.—In this section, the term 

7 ‘‘dubious marketing or distribution practice with re8 spect to an opioid’’, subject to paragraph (2), 

9 means— 

10 (A) including in any advertisement, pro11 motion, direct-to-consumer marketing materials, 

12 or other marketing material a representation 

13 that an opioid has no addiction-forming or ad14 diction-sustaining liability or has less of an ad15 diction-forming or addiction-sustaining liability 

16 than one or more other opioids, knowing the 

17 representation to be false, as determined by the 

18 Secretary of Health and Human Services (re19 ferred to in this section as the ‘‘Secretary’’), in 

20 consultation with the Commissioner of Food 

21 and Drugs (referred to in this section as the 

22 ‘‘Commissioner’’), based on research, testimoni23 als, and other evidence; 

24 (B) knowingly supplying States or commu25 nities with a quantity of opioids that the person 

26 knows is not medically reasonable; or 


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1 (C) failing to report to the Secretary any 

2 order or pattern of orders for the distribution 

3 of opioids in a State or community that the per4 son knows are not being dispensed in a medi5 cally reasonable manner. 

6 (2) LIMITATION.—An act does not constitute a 

7 ‘‘dubious marketing or distribution practice with re8 spect to an opioid’’, with respect to a natural per9 son— 

10 (A) within the meaning of paragraph 

11 (1)(B), if such natural person was not involved 

12 in the decision making regarding the quantity 

13 of opioids to supply; or 

14 (B) within the meaning of paragraph 

15 (1)(C) if such natural person knows that the 

16 Secretary should reasonably be aware of the rel17 evant order or pattern of orders for the dis18 tribution of opioids. 

19 (b) PROHIBITION.—It shall be unlawful for any per20 son involved in the manufacture or distribution of an 

21 opioid to engage in an dubious marketing or distribution 

22 practice with respect to an opioid. 

23 (c) PENALTIES.— 

24 (1) IN GENERAL.—Any person who violates 

25 subsection (b)— 


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1 (A) if a natural person employed by an 

2 opioid manufacturer or distributor, shall be— 

3 (i) subject to a civil penalty in an 

4 amount equal to the sum of— 

5 (I) such person’s full amount of 

6 salary for each year during which 

7 such person engaged in dubious mar8 keting or distribution practices with 

9 respect to an opioid product; and 

10 (II) the amount by which the 

11 stock or other certificates of owner12 ship interest of the person that is 

13 owned by the individual has increased 

14 in value during the period during 

15 which such person engaged in dubious 

16 marketing or distribution practices of 

17 an opioid product, without regard to 

18 whether the individual has sold any of 

19 the stock or certificates from such 

20 opioid manufacturer or distributor; 

21 and 

22 (ii) subject to a term of imprison23 ment— 

24 (I) with respect to a violation in25 volving a drug in schedule II of secVerDate Sep 11 2014 04:14 May 30, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1584.IS S1584

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1 tion 202 of the Controlled Substances 

2 Act (21 U.S.C. 812), of not more 

3 than 10 years; or 

4 (II) with respect to a violation in5 volving a drug in schedule III of sec6 tion 202 of the Controlled Substances 

7 Act (21 U.S.C. 812), of not more 

8 than 5 years; or 

9 (B) if a corporate entity, shall be subject 

10 to a civil penalty in the amount equal to 75 per11 cent of the total profit such corporate entity 

12 made on lawful sales of opioids in the United 

13 States during the period in which the corporate 

14 entity engaged in dubious marketing or dis15 tribution practices. 

16 (2) OTHER PENALTIES APPLICABLE IN THE

17 CASE OF A VIOLATION BY A CORPORATE ENTITY.— 

18 If a person that is a corporate entity violates sub19 section (b), the court, without regard to the partici20 pation of such individuals in, or knowledge of such 

21 individuals of, the violation, shall— 

22 (A) impose on the chief executive officer 

23 (or equivalent) of the corporate entity a civil 

24 penalty in an amount equal to the sum of— 


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1 (i) the salary of the individual during 

2 the period in which the corporate entity 

3 engaged in dubious marketing or distribu4 tion practices and such individual served 

5 as chief executive office; and 

6 (ii) the amount by which the stock or 

7 other certificates of ownership interest of 

8 the corporate entity that is owned by the 

9 individual has increased in value during 

10 the period that the corporate entity en11 gaged in dubious marketing or distribution 

12 practices and such individual served as 

13 chief executive officer, without regard to 

14 whether the individual has sold any of the 

15 stock or certificates; 

16 (B) impose on any executive other than the 

17 chief executive officer (or equivalent) who led 

18 the finance, research, marketing, or sales de19 partment of the corporate entity a civil penalty 

20 in the amount equal to the sum of— 

21 (i) 25 percent of the salary of the in22 dividual during the period that the cor23 porate entity engaged in dubious mar24 keting or distribution practices and such 

25 individual served as such an executive; 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 corporate entity 

4 that is owned by the individual has in5 creased in value during the period that the 

6 corporate entity engaged in dubious mar7 keting or distribution practices and such 

8 individual served as such an executive, 

9 without regard to whether the individual 

10 has sold any of the stock or certificates; 

11 and 

12 (C) impose on any executive, including the 

13 chief executive officer (or equivalent) who led 

14 the finance, research, marketing, or sales de15 partment of the corporate entity during the cal16 endar year in which a court enters a judgment 

17 that the corporate entity violated subsection (b) 

18 and who is not subject to a civil penalty under 

19 subparagraph (A) or (B), a civil penalty in the 

20 amount equal to the sum of— 

21 (i) 25 percent of the salary of the in22 dividual from the corporate entity during 

23 the calendar year in which a court enters 

24 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 corporate entity 

4 that is owned by the individual has in5 creased in value during the calendar year 

6 in which a court enters such judgment. 

7 (d) RULES FOR APPLICATION.— 

8 (1) QUANTITY OF OPIOIDS COVERED.— 

9 (A) FORMULA.—For purposes of subpara10 graphs (B) and (C) of subsection (a)(1), the 

11 Secretary, in consultation with the Attorney 

12 General and, as appropriate, provider groups 

13 and patient advocacy groups, using, if applica14 ble, data from the Automated Reports and Con15 solidated Ordering System of the Department 

16 of Justice, shall establish a formula for deter17 mining the quantity of opioids that is not medi18 cally reasonable with respect to a community or 

19 State. 

20 (B) REBUTTABLE PRESUMPTION.—There 

21 shall be a rebuttable presumption that a person 

22 who supplies a State or community with a 

23 quantity of opioids that is not medically reason24 able, as determined using the formula estab25 lished under paragraph (1), knowingly supplied 


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1 such quantity in violation of subsection 

2 (a)(1)(B). 

3 (2) MEDICALLY REASONABLE QUANTITIES IN

4 AN ORDER.— 

5 (A) GUIDANCE.—For purposes of sub6 section (a)(1)(C), the Secretary shall issue 

7 guidance setting forth a procedure that opioid 

8 manufacturers and distributors shall follow to 

9 recognize orders or patterns of orders for the 

10 distribution of opioids that are not medically 

11 reasonable. 

12 (B) REBUTTABLE PRESUMPTION.—There 

13 shall be a rebuttable presumption that a person 

14 who— 

15 (i) receives an order that the Sec16 retary determines to be not medically rea17 sonable and does not report such order; 

18 and 

19 (ii) did not follow the procedure set 

20 forth in the guidance described in subpara21 graph (A) with respect to such order, 

22 knowingly failed to report as described in sub23 section (a)(1)(C). 

24 (e) FEES APPLICABLE TO ALL OPIOID MANUFAC25 TURERS AND DISTRIBUTORS.— 


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1 (1) IN GENERAL.—The Secretary shall assess a 

2 fee against each corporate entity that, during the pe3 riod beginning on January 1, 1993, and ending on 

4 the day before the date of enactment of this Act, 

5 manufactured or distributed any opioid drug that 

6 was covered by a Federal health program at least 

7 once during such period, in amounts, for each such 

8 manufacturer or distributor, determined by the Sec9 retary through rulemaking. 

10 (2) TOTAL AMOUNT.—The Secretary shall en11 sure that the total amount assessed under para12 graph (1) equals $20,000,000,000. 

13 (3) DUE DATES.—With respect to a fee as14 sessed under this subsection— 

15 (A) not less than 50 percent of the amount 

16 of the fee shall be paid within 1 year of the 

17 date of enactment of this Act; and 

18 (B) 100 percent of such amount shall be 

19 paid not later than 2 years after the date of en20 actment of this Act. 

21 (4) WITHDRAWAL OF APPROVAL IN THE CASE

22 OF NONPAYMENT BY MANUFACTURER.—If a manu23 facturer assessed a fee under this subsection fails to 

24 pay the full fee as required under paragraph (3), the 

25 Secretary shall withdraw approval of the application 


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1 under section 505 of the Federal Food, Drug, and 

2 Cosmetic Act (21 U.S.C. 355) for the drug until the 

3 fee is paid in full. 

4 (5) INVESTIGATION.—Immediately after the 

5 date of enactment of this Act, the Secretary, acting 

6 through the Commissioner and in consultation with 

7 the Attorney General, acting through the Adminis8 trator of the Drug Enforcement Administration, 

9 shall begin an assessment to set fees under this sub10 section. 

11 (f) REIMBURSEMENT OF ECONOMIC IMPACT.— 

12 (1) ESTABLISHMENT OF FUND.—There is es13 tablished in the Treasury of the United States a 

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

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

16 ‘‘Fund’’), to be administered by the Secretary, in 

17 consultation with the Commissioner. 

18 (2) APPROPRIATIONS; TRANSFERS TO THE

19 FUND.— 

20 (A) APPROPRIATION.—There is appro21 priated, out of any monies in the Treasury not 

22 otherwise appropriated, $20,000,000,000 to the 

23 Fund. 

24 (B) TRANSFERS.—In a manner consistent 

25 with section 3302(b) of title 31, United States 


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1 Code, there shall be transferred to the Fund 

2 from the General Fund of the Treasury an 

3 amount equal to— 

4 (i) the amount of the civil penalties 

5 collected under subsection (c); plus 

6 (ii) the amount of fees collected under 

7 subsection (e). 

8 (C) AVAILABILITY.—Funds appropriated 

9 under paragraph (1) and transferred under 

10 subparagraph (B) shall remain available until 

11 expended. 

12 (3) USE OF FUNDS.— 

13 (A) IN GENERAL.—The Secretary, in con14 sultation with the Commissioner, may, without 

15 further appropriation, use amounts in the Fund 

16 to combat the misuse and abuse of opioids in 

17 the United States, which may include transfer18 ring amounts from the Fund to other agencies 

19 to carry out programs, projects, and activities 

20 of the agencies to combat the misuse and abuse 

21 of opioids in the United States. 

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

23 Fund, the Secretary shall give priority to pro24 viding funds for— 


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1 (i) programs, projects, and activities 

2 of the Substance Abuse and Mental Health 

3 Services Administration, the Department 

4 of Labor, the Centers for Disease Control 

5 and Prevention, and the Health Resources 

6 and Services Administration; 

7 (ii) programs, projects, and activities 

8 that provide services to individuals directly 

9 affected by the misuse and abuse of opioids 

10 (including family members of such individ11 uals); 

12 (iii) programs, projects, and activities 

13 of the Department of Education related to 

14 national activities for school safety, includ15 ing such activities authorized under section 

16 4631 of the Elementary and Secondary 

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

18 to help State and local educational agen19 cies implement evidence-based opioid mis20 use and abuse prevention strategies for 

21 schools in communities impacted by the 

22 opioid crisis, and particularly for any ap23 plicant who describes how such applicant 

24 would use the funds to prevent opioid mis25 use and abuse by students and address the 


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1 mental health needs of students affected by 

2 opioid misuse and abuse with their families 

3 or communities; and 

4 (iv) Head Start programs, including 

5 Early Head Start programs, under the 

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

7 and the Healthy Start program of the 

8 Health Resources and Services Administra9 tion to provide additional qualified child 

10 care providers trained in trauma-informed 

11 care in States with the largest number of 

12 children and families affected by the opioid 

13 crisis in their communities. 

14 (C) AVAILABILITY.—Amounts transferred 

15 to an agency under subparagraph (A) shall re16 main available until expended. 

17 (D) SUPPLEMENT NOT SUPPLANT.— 

18 Amounts transferred to an agency under sub19 paragraph (A) to carry out programs, projects, 

20 and activities of the agency shall supplement, 

21 and not supplant, amounts otherwise available 

22 for such purpose. 

23 SEC. 3. REDUCED EXCLUSIVITY. 

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

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


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

2 violated such section— 

3 (1) any remaining period of market exclusivity 

4 with respect to such covered opioid shall be revoked; 

5 (2) the period of market exclusivity with respect 

6 to any other opioid for which such manufacturer is 

7 the holder of an approved application under section 

8 505 of the Federal Food, Drug, and Cosmetic Act 

9 (21 U.S.C. 355) or a license under section 351 of 

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

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

12 market exclusivity; and 

13 (3) no new or additional exclusivity shall be 

14 awarded to any opioid for which an application is 

15 submitted by such manufacturer for approval under 

16 section 505 of the Federal Food, Drug, and Cos17 metic Act (21 U.S.C. 355) or under section 351 of 

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

19 marketed as a result of product hopping. 

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

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

22 prescription opioid drug, the sales of which in the 

23 United States, beginning on the date on which the 

24 drug was first eligible to be marketed in the United 

25 States and ending on the date on which the manuVerDate Sep 11 2014 04:14 May 30, 2019 Jkt 089200 PO 00000 Frm 00015 Fmt 6652 Sfmt 6201 E:\BILLS\S1584.IS S1584

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1 facturer was found to be in violation of section 2(b), 

2 has generated at least $1. 

3 (2) PERIOD OF MARKET EXCLUSIVITY.—The 

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

5 a drug means the total period of market exclusivity 

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

7 505(c)(3)(E) of the Federal Food, Drug, and Cos8 metic Act (21 U.S.C. 355(c)(3)(E)), section 

9 505(j)(5)(B)(iv) of such Act, clause (ii), (iii), or (iv) 

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

11 such Act (21 U.S.C. 360cc), or paragraph (6) or (7) 

12 of section 351(k) of the Public Health Service Act 

13 (42 U.S.C. 262(k)), and any extension of such a pe14 riod granted under section 505A or 505E of the 

15 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

16 355a, 355f). 

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

18 hopping’’ means a reformulation of an approved 

19 drug or biological product that allows a manufac20 turer to submit a new drug application under section 

21 505(b) of the Federal Food, Drug, and Cosmetic Act 

22 (21 U.S.C. 355(b)) or new application for a license 

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

24 Act (42 U.S.C. 262(a)) and that— 


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1 (A) is intended for the treatment of the 

2 same medical condition as the drug or biological 

3 product that was originally so approved; and 

4 (B) is undertaken in conjunction with the 

5 sponsor’s actions to reduce or eliminate demand 

6 for the original formulation of the drug or bio7 logical product. 

Æ 


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