Title: Opioid Crisis Accountability Act of 2018
Policy area: Health

Summary:
Opioid Crisis Accountability Act of 2018
This bill amends the Federal Food, Drug, and Cosmetic Act to prohibit a drug manufacturer from engaging in illegal marketing and distribution practices, including falsely advertising, promoting, or marketing that an opioid has no addiction-forming or addiction-sustaining qualities or risks.
The bill penalizes drug manufacturers or distributors who illegally advertise, market or distribute an opioid product, including by (1) imposing a civil fine or salary confiscation, (2)	revoking any remaining period of market exclusivity for such product, (3)	requiring reimbursement of federal funding received for such product, and (4)	prohibiting certain tax credits.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 2691 Introduced in Senate (IS)]

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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.

    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 
2018''.

SEC. 2. PROHIBITION OF ILLEGAL MARKETING AND DISTRIBUTION 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 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, 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 opioids that would 
        cause a reasonable person to believe the opioids were not being 
        dispensed in a medically reasonable manner.
    ``(2) It shall be unlawful for any person who manufactures 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 distribution 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 individual has 
                        increased in value during the period during 
                        which such person engaged in illegal 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) 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 section 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 marketing 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 distribution 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--
                    ``(i) impose on the chief executive officer (or 
                equivalent) of the person a civil penalty in an amount 
                equal to the sum of--
                            ``(I) the salary of the individual during 
                        the period in which the person engaged in 
                        illegal 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 
                        person that is owned by the individual has 
                        increased in value during the period that the 
                        person engaged in illegal 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;
                    ``(ii) impose on any executive other than the chief 
                executive officer (or equivalent) who led the finance, 
                research, marketing, or sales department of the person 
                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 person 
                        engaged in illegal 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 person that is owned by the 
                        individual has increased in value during the 
                        period that the person engaged in illegal 
                        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
                    ``(iii) impose on any executive, including the 
                chief executive officer (or equivalent) who led the 
                finance, research, marketing, or sales department of 
                the person during the calendar year in which a court 
                enters a judgment that the person violated paragraph 
                (2) and who is not subject to a civil penalty under 
                clause (i) or (ii), a civil penalty in the amount equal 
                to the sum of--
                            ``(I) 25 percent of the salary of the 
                        individual 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 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 creating, sustaining, and 
        exacerbating the opioid epidemic 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 consultation 
        with the Attorney General, acting through the Administrator of 
        the Drug Enforcement Administration, shall begin investigating 
        all opioid manufacturers and all executives employed by such 
        manufacturers 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)).
            (2) Retroactive effect.--Subsection (h)(2) of section 303 
        of the Federal Food, Drug, and Cosmetic 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 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 of Health 
        and Human Services (referred to in this subsection 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 Federal 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.--
                    (A) In general.--The Secretary, in consultation 
                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 providing 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, 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-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 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 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.

SEC. 3. REDUCED EXCLUSIVITY.

    (a) In General.--If a drug manufacturer violates subsection (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 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 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 
        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, or section 
        351(k)(7) of the Public Health Service Act (42 U.S.C. 
        262(k)(7)), 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.

SEC. 4. PENALTY WITH RESPECT TO OPIOIDS DEVELOPED USING FEDERAL 
              FUNDING.

    If a drug manufacturer or distributor violates subsection (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 manufacturer or distributor or 
        another entity; plus
            (2) 25 percent of the total profit such manufacturer or 
        distributor received in connection with manufacturing or 
        distributing such opioid.

SEC. 5. TREATMENT OF CERTAIN TAX CREDITS FOR VIOLATORS OF ILLEGAL 
              MARKETING AND DISTRIBUTION PRACTICES WITH RESPECT TO 
              OPIOIDS.

    (a) In General.--Section 41 of the Internal Revenue Code of 1986 is 
amended by adding at the end the following new subsection:
    ``(i) Treatment of Certain Taxpayers Violating Illegal Marketing 
and Distribution Practices With Respect to Opioids.--
            ``(1) In general.--In the case of any taxpayer who has 
        engaged in an illegal marketing or distribution 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 subsection 
                (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 paragraph (2)(B).
            ``(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 distribution 
                        practice with respect to the opioid permanently 
                        ceased, or
                            ``(ii) the date on which the civil penalty 
                        described in subparagraph (A) is imposed.
        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.''.
    (b) Effective Date.--The amendments made by this section shall 
apply to taxable years ending after the date of the enactment of this 
Act.
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