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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 exacer-
bating 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 re-
ferred 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 epi-
demic in the United States.
Be it enacted by the Senate and House of Representa-
1
tives of the United States of America in Congress assembled,
2
SECTION 1. SHORT TITLE.
3
This Act may be cited as the ‘‘Opioid Crisis Account-
4
ability Act of 2019’’.
5
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•S 1584 IS
SEC. 2. PROHIBITION OF DUBIOUS MARKETING AND MEDI-
1
CALLY UNREASONABLE DISTRIBUTION PRAC-
2
TICES WITH RESPECT TO OPIOIDS.
3
(a) DUBIOUS MARKETING OR DISTRIBUTION PRAC-
4
TICE WITH RESPECT TO AN OPIOID.—
5
(1) IN
GENERAL.—In this section, the term
6
‘‘dubious marketing or distribution practice with re-
7
spect to an opioid’’, subject to paragraph (2),
8
means—
9
(A) including in any advertisement, pro-
10
motion, direct-to-consumer marketing materials,
11
or other marketing material a representation
12
that an opioid has no addiction-forming or ad-
13
diction-sustaining liability or has less of an ad-
14
diction-forming or addiction-sustaining liability
15
than one or more other opioids, knowing the
16
representation to be false, as determined by the
17
Secretary of Health and Human Services (re-
18
ferred to in this section as the ‘‘Secretary’’), in
19
consultation with the Commissioner of Food
20
and Drugs (referred to in this section as the
21
‘‘Commissioner’’), based on research, testimoni-
22
als, and other evidence;
23
(B) knowingly supplying States or commu-
24
nities with a quantity of opioids that the person
25
knows is not medically reasonable; or
26
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•S 1584 IS
(C) failing to report to the Secretary any
1
order or pattern of orders for the distribution
2
of opioids in a State or community that the per-
3
son knows are not being dispensed in a medi-
4
cally reasonable manner.
5
(2) LIMITATION.—An act does not constitute a
6
‘‘dubious marketing or distribution practice with re-
7
spect to an opioid’’, with respect to a natural per-
8
son—
9
(A) within the meaning of paragraph
10
(1)(B), if such natural person was not involved
11
in the decision making regarding the quantity
12
of opioids to supply; or
13
(B) within the meaning of paragraph
14
(1)(C) if such natural person knows that the
15
Secretary should reasonably be aware of the rel-
16
evant order or pattern of orders for the dis-
17
tribution of opioids.
18
(b) PROHIBITION.—It shall be unlawful for any per-
19
son involved in the manufacture or distribution of an
20
opioid to engage in an dubious marketing or distribution
21
practice with respect to an opioid.
22
(c) PENALTIES.—
23
(1) IN
GENERAL.—Any person who violates
24
subsection (b)—
25
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(A) if a natural person employed by an
1
opioid manufacturer or distributor, shall be—
2
(i) subject to a civil penalty in an
3
amount equal to the sum of—
4
(I) such person’s full amount of
5
salary for each year during which
6
such person engaged in dubious mar-
7
keting or distribution practices with
8
respect to an opioid product; and
9
(II) the amount by which the
10
stock or other certificates of owner-
11
ship interest of the person that is
12
owned by the individual has increased
13
in value during the period during
14
which such person engaged in dubious
15
marketing or distribution practices of
16
an opioid product, without regard to
17
whether the individual has sold any of
18
the stock or certificates from such
19
opioid manufacturer or distributor;
20
and
21
(ii) subject to a term of imprison-
22
ment—
23
(I) with respect to a violation in-
24
volving a drug in schedule II of sec-
25
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•S 1584 IS
tion 202 of the Controlled Substances
1
Act (21 U.S.C. 812), of not more
2
than 10 years; or
3
(II) with respect to a violation in-
4
volving a drug in schedule III of sec-
5
tion 202 of the Controlled Substances
6
Act (21 U.S.C. 812), of not more
7
than 5 years; or
8
(B) if a corporate entity, shall be subject
9
to a civil penalty in the amount equal to 75 per-
10
cent of the total profit such corporate entity
11
made on lawful sales of opioids in the United
12
States during the period in which the corporate
13
entity engaged in dubious marketing or dis-
14
tribution practices.
15
(2) OTHER
PENALTIES
APPLICABLE
IN
THE
16
CASE OF A VIOLATION BY A CORPORATE ENTITY.—
17
If a person that is a corporate entity violates sub-
18
section (b), the court, without regard to the partici-
19
pation of such individuals in, or knowledge of such
20
individuals of, the violation, shall—
21
(A) impose on the chief executive officer
22
(or equivalent) of the corporate entity a civil
23
penalty in an amount equal to the sum of—
24
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(i) the salary of the individual during
1
the period in which the corporate entity
2
engaged in dubious marketing or distribu-
3
tion practices and such individual served
4
as chief executive office; and
5
(ii) the amount by which the stock or
6
other certificates of ownership interest of
7
the corporate entity that is owned by the
8
individual has increased in value during
9
the period that the corporate entity en-
10
gaged in dubious marketing or distribution
11
practices and such individual served as
12
chief executive officer, without regard to
13
whether the individual has sold any of the
14
stock or certificates;
15
(B) impose on any executive other than the
16
chief executive officer (or equivalent) who led
17
the finance, research, marketing, or sales de-
18
partment of the corporate entity a civil penalty
19
in the amount equal to the sum of—
20
(i) 25 percent of the salary of the in-
21
dividual during the period that the cor-
22
porate entity engaged in dubious mar-
23
keting or distribution practices and such
24
individual served as such an executive; and
25
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•S 1584 IS
(ii) 25 percent of the amount by
1
which the stock or other certificates of
2
ownership interest of the corporate entity
3
that is owned by the individual has in-
4
creased in value during the period that the
5
corporate entity engaged in dubious mar-
6
keting or distribution practices and such
7
individual served as such an executive,
8
without regard to whether the individual
9
has sold any of the stock or certificates;
10
and
11
(C) impose on any executive, including the
12
chief executive officer (or equivalent) who led
13
the finance, research, marketing, or sales de-
14
partment of the corporate entity during the cal-
15
endar year in which a court enters a judgment
16
that the corporate entity violated subsection (b)
17
and who is not subject to a civil penalty under
18
subparagraph (A) or (B), a civil penalty in the
19
amount equal to the sum of—
20
(i) 25 percent of the salary of the in-
21
dividual from the corporate entity during
22
the calendar year in which a court enters
23
such judgment; and
24
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(ii) 25 percent of the amount by
1
which the stock or other certificates of
2
ownership interest of the corporate entity
3
that is owned by the individual has in-
4
creased in value during the calendar year
5
in which a court enters such judgment.
6
(d) RULES FOR APPLICATION.—
7
(1) QUANTITY OF OPIOIDS COVERED.—
8
(A) FORMULA.—For purposes of subpara-
9
graphs (B) and (C) of subsection (a)(1), the
10
Secretary, in consultation with the Attorney
11
General and, as appropriate, provider groups
12
and patient advocacy groups, using, if applica-
13
ble, data from the Automated Reports and Con-
14
solidated Ordering System of the Department
15
of Justice, shall establish a formula for deter-
16
mining the quantity of opioids that is not medi-
17
cally reasonable with respect to a community or
18
State.
19
(B) REBUTTABLE
PRESUMPTION.—There
20
shall be a rebuttable presumption that a person
21
who supplies a State or community with a
22
quantity of opioids that is not medically reason-
23
able, as determined using the formula estab-
24
lished under paragraph (1), knowingly supplied
25
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•S 1584 IS
such
quantity
in
violation
of
subsection
1
(a)(1)(B).
2
(2) MEDICALLY
REASONABLE
QUANTITIES
IN
3
AN ORDER.—
4
(A) GUIDANCE.—For purposes of sub-
5
section (a)(1)(C), the Secretary shall issue
6
guidance setting forth a procedure that opioid
7
manufacturers and distributors shall follow to
8
recognize orders or patterns of orders for the
9
distribution of opioids that are not medically
10
reasonable.
11
(B) REBUTTABLE
PRESUMPTION.—There
12
shall be a rebuttable presumption that a person
13
who—
14
(i) receives an order that the Sec-
15
retary determines to be not medically rea-
16
sonable and does not report such order;
17
and
18
(ii) did not follow the procedure set
19
forth in the guidance described in subpara-
20
graph (A) with respect to such order,
21
knowingly failed to report as described in sub-
22
section (a)(1)(C).
23
(e) FEES APPLICABLE TO ALL OPIOID MANUFAC-
24
TURERS AND DISTRIBUTORS.—
25
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(1) IN GENERAL.—The Secretary shall assess a
1
fee against each corporate entity that, during the pe-
2
riod beginning on January 1, 1993, and ending on
3
the day before the date of enactment of this Act,
4
manufactured or distributed any opioid drug that
5
was covered by a Federal health program at least
6
once during such period, in amounts, for each such
7
manufacturer or distributor, determined by the Sec-
8
retary through rulemaking.
9
(2) TOTAL AMOUNT.—The Secretary shall en-
10
sure that the total amount assessed under para-
11
graph (1) equals $20,000,000,000.
12
(3) DUE
DATES.—With respect to a fee as-
13
sessed under this subsection—
14
(A) not less than 50 percent of the amount
15
of the fee shall be paid within 1 year of the
16
date of enactment of this Act; and
17
(B) 100 percent of such amount shall be
18
paid not later than 2 years after the date of en-
19
actment of this Act.
20
(4) WITHDRAWAL OF APPROVAL IN THE CASE
21
OF NONPAYMENT BY MANUFACTURER.—If a manu-
22
facturer assessed a fee under this subsection fails to
23
pay the full fee as required under paragraph (3), the
24
Secretary shall withdraw approval of the application
25
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under section 505 of the Federal Food, Drug, and
1
Cosmetic Act (21 U.S.C. 355) for the drug until the
2
fee is paid in full.
3
(5) INVESTIGATION.—Immediately after the
4
date of enactment of this Act, the Secretary, acting
5
through the Commissioner and in consultation with
6
the Attorney General, acting through the Adminis-
7
trator of the Drug Enforcement Administration,
8
shall begin an assessment to set fees under this sub-
9
section.
10
(f) REIMBURSEMENT OF ECONOMIC IMPACT.—
11
(1) ESTABLISHMENT OF FUND.—There is es-
12
tablished in the Treasury of the United States a
13
fund, to be known as the ‘‘Opioids Reimbursement
14
Fund’’ (referred to in this subsection as the
15
‘‘Fund’’), to be administered by the Secretary, in
16
consultation with the Commissioner.
17
(2) APPROPRIATIONS;
TRANSFERS
TO
THE
18
FUND.—
19
(A) APPROPRIATION.—There is appro-
20
priated, out of any monies in the Treasury not
21
otherwise appropriated, $20,000,000,000 to the
22
Fund.
23
(B) TRANSFERS.—In a manner consistent
24
with section 3302(b) of title 31, United States
25
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Code, there shall be transferred to the Fund
1
from the General Fund of the Treasury an
2
amount equal to—
3
(i) the amount of the civil penalties
4
collected under subsection (c); plus
5
(ii) the amount of fees collected under
6
subsection (e).
7
(C) AVAILABILITY.—Funds appropriated
8
under paragraph (1) and transferred under
9
subparagraph (B) shall remain available until
10
expended.
11
(3) USE OF FUNDS.—
12
(A) IN GENERAL.—The Secretary, in con-
13
sultation with the Commissioner, may, without
14
further appropriation, use amounts in the Fund
15
to combat the misuse and abuse of opioids in
16
the United States, which may include transfer-
17
ring amounts from the Fund to other agencies
18
to carry out programs, projects, and activities
19
of the agencies to combat the misuse and abuse
20
of opioids in the United States.
21
(B) PRIORITY.—In using amounts in the
22
Fund, the Secretary shall give priority to pro-
23
viding funds for—
24
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(i) programs, projects, and activities
1
of the Substance Abuse and Mental Health
2
Services Administration, the Department
3
of Labor, the Centers for Disease Control
4
and Prevention, and the Health Resources
5
and Services Administration;
6
(ii) programs, projects, and activities
7
that provide services to individuals directly
8
affected by the misuse and abuse of opioids
9
(including family members of such individ-
10
uals);
11
(iii)
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