[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 1584 Introduced in Senate (IS)]
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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.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Opioid Crisis Accountability Act of
2019''.
SEC. 2. PROHIBITION OF DUBIOUS MARKETING AND MEDICALLY UNREASONABLE
DISTRIBUTION PRACTICES WITH RESPECT TO OPIOIDS.
(a) Dubious Marketing or Distribution Practice With Respect to an
Opioid.--
(1) In general.--In this section, the term ``dubious
marketing or distribution practice with respect to an opioid'',
subject to paragraph (2), 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 liability
or has less of an addiction-forming or addiction-
sustaining liability than one or more other opioids,
knowing the representation to be false, as determined
by the Secretary of Health and Human Services (referred
to in this section as the ``Secretary''), in
consultation with the Commissioner of Food and Drugs
(referred to in this section as the ``Commissioner''),
based on research, testimonials, and other evidence;
(B) knowingly supplying States or communities with
a quantity of opioids that the person knows is not
medically reasonable; or
(C) failing to report to the Secretary any order or
pattern of orders for the distribution of opioids in a
State or community that the person knows are not being
dispensed in a medically reasonable manner.
(2) Limitation.--An act does not constitute a ``dubious
marketing or distribution practice with respect to an opioid'',
with respect to a natural person--
(A) within the meaning of paragraph (1)(B), if such
natural person was not involved in the decision making
regarding the quantity of opioids to supply; or
(B) within the meaning of paragraph (1)(C) if such
natural person knows that the Secretary should
reasonably be aware of the relevant order or pattern of
orders for the distribution of opioids.
(b) Prohibition.--It shall be unlawful for any person involved in
the manufacture or distribution of an opioid to engage in an dubious
marketing or distribution practice with respect to an opioid.
(c) Penalties.--
(1) In general.--Any person who violates subsection (b)--
(A) 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--
(I) such person's full amount of
salary for each year during which such
person engaged in dubious marketing or
distribution practices with respect to
an opioid product; and
(II) 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 period during which such
person engaged in dubious marketing or
distribution practices of an opioid
product, without regard to whether the
individual has sold any of the stock or
certificates from such opioid
manufacturer or distributor; and
(ii) subject to a term of imprisonment--
(I) with respect to a violation
involving a drug in schedule II of
section 202 of the Controlled
Substances Act (21 U.S.C. 812), of not
more than 10 years; or
(II) with respect to a violation
involving a drug in schedule III of
section 202 of the Controlled
Substances Act (21 U.S.C. 812), of not
more than 5 years; or
(B) if a corporate entity, shall be subject to a
civil penalty in the amount equal to 75 percent of the
total profit such corporate entity made on lawful sales
of opioids in the United States during the period in
which the corporate entity engaged in dubious marketing
or distribution practices.
(2) Other penalties applicable in the case of a violation
by a corporate entity.--If a person that is a corporate entity
violates subsection (b), the court, without regard to the
participation of such individuals in, or knowledge of such
individuals of, the violation, shall--
(A) impose on the chief executive officer (or
equivalent) of the corporate entity a civil penalty in
an amount equal to the sum of--
(i) the salary of the individual during the
period in which the corporate entity engaged in
dubious marketing or distribution practices and
such individual served as chief executive
office; and
(ii) the amount by which the stock or other
certificates of ownership interest of the
corporate entity that is owned by the
individual has increased in value during the
period that the corporate entity engaged in
dubious marketing or distribution practices and
such individual served as chief executive
officer, without regard to whether the
individual has sold any of the stock or
certificates;
(B) impose on any executive other than the chief
executive officer (or equivalent) who led the finance,
research, marketing, or sales department of the
corporate entity a civil penalty in the amount equal to
the sum of--
(i) 25 percent of the salary of the
individual during the period that the corporate
entity engaged in dubious marketing or
distribution practices and such individual
served as such an executive; and
(ii) 25 percent of the amount by which the
stock or other certificates of ownership
interest of the corporate entity that is owned
by the individual has increased in value during
the period that the corporate entity engaged in
dubious marketing or distribution practices and
such individual served as such an executive,
without regard to whether the individual has
sold any of the stock or certificates; and
(C) impose on any executive, including the chief
executive officer (or equivalent) who led the finance,
research, marketing, or sales department of the
corporate entity during the calendar year in which a
court enters a judgment that the corporate entity
violated subsection (b) and who is not subject to a
civil penalty under subparagraph (A) or (B), a civil
penalty in the amount equal to the sum of--
(i) 25 percent of the salary of the
individual from the corporate entity during the
calendar year in which a court enters such
judgment; and
(ii) 25 percent of the amount by which the
stock or other certificates of ownership
interest of the corporate entity that is owned
by the individual has increased in value during
the calendar year in which a court enters such
judgment.
(d) Rules for Application.--
(1) Quantity of opioids covered.--
(A) Formula.--For purposes of subparagraphs (B) and
(C) of subsection (a)(1), the Secretary, in
consultation with the Attorney General and, as
appropriate, provider groups and patient advocacy
groups, using, if applicable, data from the Automated
Reports and Consolidated Ordering System of the
Department of Justice, shall establish a formula for
determining the quantity of opioids that is not
medically reasonable with respect to a community or
State.
(B) Rebuttable presumption.--There shall be a
rebuttable presumption that a person who supplies a
State or community with a quantity of opioids that is
not medically reasonable, as determined using the
formula established under paragraph (1), knowingly
supplied such quantity in violation of subsection
(a)(1)(B).
(2) Medically reasonable quantities in an order.--
(A) Guidance.--For purposes of subsection
(a)(1)(C), the Secretary shall issue guidance setting
forth a procedure that opioid manufacturers and
distributors shall follow to recognize orders or
patterns of orders for the distribution of opioids that
are not medically reasonable.
(B) Rebuttable presumption.--There shall be a
rebuttable presumption that a person who--
(i) receives an order that the Secretary
determines to be not medically reasonable and
does not report such order; and
(ii) did not follow the procedure set forth
in the guidance described in subparagraph (A)
with respect to such order,
knowingly failed to report as described in subsection
(a)(1)(C).
(e) Fees Applicable to All Opioid Manufacturers and Distributors.--
(1) In general.--The Secretary shall assess a fee against
each corporate entity that, during the period beginning on
January 1, 1993, and ending on the day before the date of
enactment of this Act, manufactured or distributed any opioid
drug that was covered by a Federal health program at least once
during such period, in amounts, for each such manufacturer or
distributor, determined by the Secretary through rulemaking.
(2) Total amount.--The Secretary shall ensure that the
total amount assessed under paragraph (1) equals
$20,000,000,000.
(3) Due dates.--With respect to a fee assessed under this
subsection--
(A) not less than 50 percent of the amount of the
fee shall be paid within 1 year of the date of
enactment of this Act; and
(B) 100 percent of such amount shall be paid not
later than 2 years after the date of enactment of this
Act.
(4) Withdrawal of approval in the case of nonpayment by
manufacturer.--If a manufacturer assessed a fee under this
subsection fails to pay the full fee as required under
paragraph (3), the Secretary shall withdraw approval of the
application under section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355) for the drug until the fee is paid
in full.
(5) Investigation.--Immediately after the date of enactment
of this Act, the Secretary, acting through the Commissioner and
in consultation with the Attorney General, acting through the
Administrator of the Drug Enforcement Administration, shall
begin an assessment to set fees under this subsection.
(f) Reimbursement of Economic Impact.--
(1) Establishment of fund.--There is established 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, in
consultation with the Commissioner.
(2) Appropriations; transfers to the fund.--
(A) Appropriation.--There is appropriated, out of
any monies in the Treasury not otherwise appropriated,
$20,000,000,000 to the Fund.
(B) Transfers.--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--
(i) the amount of the civil penalties
collected under subsection (c); plus
(ii) the amount of fees collected under
subsection (e).
(C) Availability.--Funds appropriated under
paragraph (1) and transferred under subparagraph (B)
shall remain available until expended.
(3) Use of funds.--
(A) In general.--The Secretary, in consultation
with the Commissioner, may, without further
appropriation, use amounts in the Fund to combat the
misuse and 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 misuse and
abuse of opioids in the United States.
(B) Priority.--In using amounts in the Fund, the
Secretary shall give priority to providing funds for--
(i) programs, projects, and activities of
the Substance Abuse and Mental Health Services
Administration, the Department of Labor, the
Centers for Disease Control and Prevention, and
the Health Resources and Services
Administration;
(ii) programs, projects, and activities
that provide services to individuals directly
affected by the misuse and 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, including such
activities authorized under section 4631 of the
Elementary and Secondary Education Act of 1965
(20 U.S.C. 7281) to help State and local
educational agencies implement evidence-based
opioid misuse and abuse prevention strategies
for schools in communities impacted by the
opioid crisis, and particularly for any
applicant who describes how such applicant
would use the funds to prevent opioid misuse
and abuse by students and address the mental
health needs of students affected by opioid
misuse and 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.) and the Healthy Start
program of the Health Resources and Services
Administration to provide additional qualified
child care providers trained in trauma-informed
care in States with the largest number of
children and families affected by the opioid
crisis in their communities.
(C) Availability.--Amounts transferred to an agency
under subparagraph (A) shall remain available until
expended.
(D) Supplement not supplant.--Amounts transferred
to an agency under subparagraph (A) to carry out
programs, projects, and activities of the agency shall
supplement, and not supplant, amounts otherwise
available for such purpose.
SEC. 3. REDUCED EXCLUSIVITY.
(a) In General.--If a drug manufacturer violates section 2(b) 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 Cosmetic 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 drug was first eligible to be marketed
in the United States and ending on the date on which the
manufacturer was found to be in violation of section 2(b), 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
Cosmetic 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 (21 U.S.C.
360cc), or paragraph (6) or (7) of section 351(k) of the Public
Health Service Act (42 U.S.C. 262(k)), and any extension 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 manufacturer 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 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 biological product.
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