I 
115TH CONGRESS 
2D SESSION 
H. R. 5782 
To hold pharmaceutical companies accountable for illegal marketing and dis-
tribution of opioid products and for their role in creating and exacer-
bating the opioid epidemic in the United States. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 11, 2018 
Ms. GABBARD (for herself and Mr. KHANNA) introduced the following bill; 
which was referred to the Committee on Energy and Commerce, and in 
addition to the Committees on Education and the Workforce, Ways and 
Means, and the Judiciary, for a period to be subsequently determined by 
the Speaker, in each case for consideration of such provisions as fall with-
in the jurisdiction of the committee concerned 
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 epi-
demic in the United States. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Opioid Crisis Account-
ability Act of 2018’’. 
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SEC. 2. PROHIBITION OF ILLEGAL MARKETING AND DIS-
TRIBUTION PRACTICES WITH RESPECT TO 
OPIOIDS. 
(a) IN GENERAL.—Section 303 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 333) is amended by 
adding at the end the following: 
‘‘(h)(1) In this subsection, the term ‘illegal marketing 
or distribution practice with respect to an opioid’ means— 
‘‘(A) including in any advertisement, promotion, 
direct-to-consumer marketing materials, or other 
marketing material a representation that an opioid 
has no addiction-forming or addiction-sustaining li-
ability or has less of an addiction-forming or addic-
tion-sustaining liability than 1 or more other opioids, 
knowing the representation to be false, as deter-
mined by the Secretary, in consultation with the 
Commissioner, based on research, testimonials, and 
other evidence; 
‘‘(B) supplying States or communities with a 
quantity of opioids that is not medically reasonable, 
as determined by the Secretary, in consultation with 
the Attorney General using, if applicable, data from 
the Automated Reports and Consolidated Ordering 
System of the Department of Justice; or 
‘‘(C) failing to report to the Secretary any 
order or pattern of orders for the distribution of 
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opioids that would cause a reasonable person to be-
lieve the opioids were not being dispensed in a medi-
cally reasonable manner. 
‘‘(2) It shall be unlawful for any person who manu-
factures or distributes an opioid to engage in an illegal 
marketing or distribution practice with respect to an 
opioid. 
‘‘(3)(A) Any person who violates paragraph (2)— 
‘‘(i) if a natural person employed by an opioid 
manufacturer or distributor, shall be— 
‘‘(I) subject to a civil penalty in an amount 
equal to the sum of— 
‘‘(aa) such person’s full amount of 
salary for each year during which such 
person engaged in illegal marketing or dis-
tribution practices with respect to an 
opioid product; and 
‘‘(bb) the amount by which the stock 
or other certificates of ownership interest 
of the person that is owned by the indi-
vidual has increased in value during the 
period during which such person engaged 
in illegal marketing or distribution prac-
tices of an opioid product, without regard 
to whether the individual has sold any of 
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the stock or certificates from such opioid 
manufacturer or distributor; and 
‘‘(II) with respect to a violation that occurs 
on or after the date of enactment of the Opioid 
Crisis Accountability Act of 2018, subject to 
the period of imprisonment specified under sec-
tion 401 of the Controlled Substances Act that 
would be applicable for a violation of subsection 
(a) of such section that involved the quantity of 
opioids that were involved in the illegal mar-
keting or distribution practices with respect to 
an opioid; 
‘‘(ii) if not a natural person, shall be subject to 
a civil penalty in the amount equal to the sum of— 
‘‘(I) $7,800,000,000; plus 
‘‘(II) 25 percent of the total profit such 
person made on lawful sales of opioids in the 
United States during the period in which the 
person engaged in illegal marketing or distribu-
tion practices. 
‘‘(B) If a person that is not a natural person 
violates paragraph (2), the court, without regard to 
the participation of such individuals in, or knowledge 
of such individuals of, the violation, shall— 
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‘‘(II) 25 percent of the amount by 
which the stock or other certificates of 
ownership interest of the person that is 
owned by the individual has increased in 
value during the calendar year in which a 
court enters such judgment. 
‘‘(C) Any person described in clause (i) or (ii) 
of subparagraph (A) shall be required to issue a 
public statement apologizing for their role in cre-
ating, sustaining, and exacerbating the opioid epi-
demic in the United States.’’. 
(b) INVESTIGATION; RETROACTIVE EFFECT.— 
(1) INVESTIGATION.—Immediately after the 
date of enactment of this Act, the Secretary of 
Health and Human Services, acting through the 
Commissioner of Food and Drugs and in consulta-
tion with the Attorney General, acting through the 
Administrator of the Drug Enforcement Administra-
tion, shall begin investigating all opioid manufactur-
ers and all executives employed by such manufactur-
ers to determine whether any such manufacturers or 
executives, at any time before or after such date of 
enactment, violated subsection (h)(2) of section 303 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 333) (as added by subsection (a)). 
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(2) RETROACTIVE EFFECT.—Subsection (h)(2) 
of section 303 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 333) (as added by subsection 
(a)) shall take effect on January 1, 1985, and shall 
have retroactive effect. 
(c) REIMBURSEMENT OF ECONOMIC IMPACT.— 
(1) ESTABLISHMENT OF FUND.—There is es-
tablished in the Treasury of the United States a 
fund, to be known as the ‘‘Opioids Reimbursement 
Fund’’ (referred to in this subsection as the 
‘‘Fund’’), to be administered by the Secretary of 
Health and Human Services (referred to in this sub-
section as the ‘‘Secretary’’), in consultation with the 
Commissioner of Food and Drugs. 
(2) TRANSFERS TO THE FUND.—In a manner 
consistent with section 3302(b) of title 31, United 
States Code, there shall be transferred to the Fund 
from the General Fund of the Treasury an amount 
equal to the amount of the civil penalties collected 
under subsection (h)(3) of section 303 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 333) 
(as added by subsection (a)), which shall remain 
available until expended. 
(3) USE OF FUNDS.— 
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(A) IN GENERAL.—The Secretary, in con-
sultation with the Commissioner of Food and 
Drugs, may, without further appropriation, use 
amounts in the Fund to combat the abuse of 
opioids in the United States, which may include 
transferring amounts from the Fund to other 
agencies to carry out programs, projects, and 
activities of the agencies to combat the abuse of 
opioids in the United States. 
(B) PRIORITY.—In using amounts in the 
Fund, the Secretary shall give priority to pro-
viding funds for— 
(i) programs, projects, and activities 
of the Substance Abuse and Mental Health 
Services Administration, the Department 
of Labor, and the Department of Justice; 
(ii) programs, projects, and activities 
that provide services to individuals directly 
affected by the abuse of opioids (including 
family members of such individuals); 
(iii) programs, projects, and activities 
of the Department of Education related to 
national activities for school safety, includ-
ing such activities authorized under section 
4631 of the Elementary and Secondary 
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Education Act of 1965 (20 U.S.C. 7281) 
to help State and local educational agen-
cies implement evidence-based opioid-abuse 
prevention strategies for schools in commu-
nities impacted by the opioid crisis, and 
particularly for any applicant who de-
scribes how such applicant would use the 
funds to prevent opioid abuse by students 
and address the mental health needs of 
students affected by opioid abuse with 
their families or communities; and 
(iv) Head Start programs, including 
Early Head Start programs, under the 
Head Start Act (42 U.S.C. 9831 et seq.), 
to provide additional qualified child care 
providers trained in trauma-informed care 
in States with the largest number of chil-
dren and families affected by the opioid 
crisis in their communities. 
(C) AVAILABILITY.—Amounts transferred 
to an agency under subparagraph (A) shall re-
main available until expended. 
SEC. 3. REDUCED EXCLUSIVITY. 
(a) IN GENERAL.—If a drug manufacturer violates 
subsection (h)(2) of section 303 of the Federal Food, 
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Drug, and Cosmetic Act (21 U.S.C. 333) (as added by 
section 2) with respect to a covered opioid, effective on 
the date on which such manufacturer is found to have so 
violated such section— 
(1) any remaining period of market exclusivity 
with respect to such covered opioid shall be revoked; 
(2) the period of market exclusivity with respect 
to any other opioid for which such manufacturer is 
the holder of an approved application under section 
505 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355) or a license under section 351 of 
the Public Health Service Act (42 U.S.C. 262) shall 
be reduced to one half of the remaining period of 
market exclusivity; and 
(3) no new or additional exclusivity shall be 
awarded to any opioid for which an application is 
submitted by such manufacturer for approval under 
section 505 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355) or under section 351 of 
the Public Health Service Act (42 U.S.C. 262) or 
marketed as a result of product hopping. 
(b) DEFINITIONS.—For purposes of this section: 
(1) COVERED OPIOID.—A ‘‘covered opioid’’ is a 
prescription opioid drug, the sales of which in the 
United States, beginning on the date on which the 
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drug was first eligible to be marketed in the United 
States and ending on the date on which the manu-
facturer was found to be in violation of subsection 
(h)(2) of section 303 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 333), has generated at 
least $1. 
(2) PERIOD
OF
MARKET
EXCLUSIVITY.—The 
term ‘‘period of market exclusivity’’ with respect to 
a drug means the total period of market exclusivity 
granted under clause (ii), (iii), or (iv) of section 
505(c)(3)(E) of the Federal Food, Drug, and Cos-
metic 
Act 
(21 
U.S.C. 
355(c)(3)(E)), 
section 
505(j)(5)(B)(iv) of such Act, clause (ii), (iii), or (iv) 
of section 505(j)(5)(F) of such Act, section 527 of 
such Act, or section 351(k)(7) of the Public Health 
Service Act (42 U.S.C. 262(k)(7)), and any exten-
sion of such a period granted under section 505A or 
505E of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355a, 355f). 
(3) PRODUCT
HOPPING.—The term ‘‘product 
hopping’’ means a reformulation of an approved 
drug or biological product that allows a manufac-
turer to submit a new drug application under section 
505(b) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355(b)) or new application for a license 
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under section 351(a) of the Public Health Service 
Act (42 U.S.C. 262(a)) and that— 
(A) is intended for the treatment of the 
same medical condition as the drug or biological 
product that was originally so approved; and 
(B) is undertaken in conjunction with the 
sponsor’s actions to reduce or eliminate demand 
for the original formulation of the drug or bio-
logical product. 
SEC. 4. PENALTY WITH RESPECT TO OPIOIDS DEVELOPED 
USING FEDERAL FUNDING. 
If a drug manufacturer or distributor violates sub-
section (h)(2) of section 303 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 333) (as added by section 
2) with respect to an opioid that was developed with the 
support of Federal funding, in addition to the applicable 
penalties under such subsection (h), such manufacturer or 
distributor shall be subject to a civil penalty in an amount 
equal to the sum of— 
(1) such Federal funding, regardless of whether 
the Federal funding was received by the manufac-
turer or distributor or another entity; plus 
(2) 25 percent of the total profit such manufac-
turer or distributor received in connection with man-
ufacturing or distributing such opioid. 
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SEC. 5. TREATMENT OF CERTAIN TAX CREDITS FOR VIOLA-
TORS OF ILLEGAL MARKETING AND DIS-
TRIBUTION PRACTICES WITH RESPECT TO 
OPIOIDS. 
(a) IN GENERAL.—Section 41 of the Internal Rev-
enue Code of 1986 is amended by adding at the end the 
following new subsection: 
‘‘(i) TREATMENT
OF CERTAIN TAXPAYERS VIO-
LATING ILLEGAL MARKETING AND DISTRIBUTION PRAC-
TICES WITH RESPECT TO OPIOIDS.— 
‘‘(1) IN GENERAL.—In the case of any taxpayer 
who has engaged in an illegal marketing or distribu-
tion practice with respect to an opioid (within the 
meaning of section 303(h) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 333))— 
‘‘(A) no credit shall be allowed under sub-
section (a), section 45C(a), or section 3111(f) 
for any taxable year in the applicable period, 
and 
‘‘(B) the taxpayer’s tax under this chapter 
for the taxable year described in paragraph 
(2)(A) shall be increased by an amount equal to 
the amount of credits allowed to such taxpayer 
by reason of subsection (a), section 45C(a), and 
section 3111(f) for the period described in para-
graph (2)(B). 
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‘‘(2) APPLICABLE
PERIOD.—For purposes of 
this subsection, the term ‘applicable period’ means 
the period of taxable years which— 
‘‘(A) begins with the taxable year in which 
a civil penalty has been imposed for an illegal 
marketing or distribution practice with respect 
to an opioid under section 303(h)(3) of the 
Federal Food, Drug, and Cosmetic Act, and 
‘‘(B) has a duration equal to the number 
of taxable years in the period that begins with 
the first day on which the illegal marketing or 
distribution practice with respect to the opioid 
occurred and ends on the earlier of date on 
which— 
‘‘(i) the illegal marketing or distribu-
tion practice with respect to the opioid per-
manently ceased, or 
‘‘(ii) the date on which the civil pen-
alty described in subparagraph (A) is im-
posed. 
For purposes of subparagraph (B), any portion of a 
taxable year that is less than a whole taxable year 
shall be treated as a whole taxable year.’’. 
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(b) EFFECTIVE DATE.—The amendments made by 
this section shall apply to taxable years ending after the 
date of the enactment of this Act. 
Æ 
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