Title: Opioid Crisis Accountability Act of 2019
Policy area: Health

Summary:
Opioid Crisis Accountability Act of 2019
This bill establishes a series of restrictions and requirements relating to opioid marketing and distribution practices.
Specifically, the bill prohibits (1) knowingly making false advertising or marketing claims regarding the addictive nature of opioids; (2) knowingly supplying communities with quantities of opioids that are not medically reasonable; or (3) failing to report distribution orders, or patterns of orders, while knowing that the orders are not being dispensed in a medically reasonable manner. Employees of opioid manufacturers and distributors are subject to civil penalties and imprisonment for violations; corporations and executives are subject to civil penalties. Manufacturers shall also lose their period of market exclusivity.
Additionally, the Department of Health and Human Services must assess a fee against each corporation that, between January 1, 1993, and the date of enactment of this bill, manufactured or distributed opioids, if such opioids were covered under a federal health program at least once during this period. Manufacturers that fail to pay the fee shall lose associated drug approval until the fee is paid in full.
The bill authorizes collected civil penalties and fees to be used for activities that address opioid misuse and abuse, including family and educational programs.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 1584 Introduced in Senate (IS)]

<DOC>






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.
                                 <all>