Title: Using Data to Prevent Opioid Diversion Act of 2018
Policy area: Crime and Law Enforcement

Summary:
Using Data to Prevent Opioid Diversion Act of 2018
This bill establishes a new requirement intended to help drug manufacturers and distributors identify and prevent suspicious orders of opioids and reduce rates of diversion.
Specifically, the Drug Enforcement Administration must use its automated data system—the Automated Reports and Consolidated Ordering System—to inform drug manufacturers and distributors about the quantity and type of opioids that are distributed to pharmacies and practitioners.
Additionally, the bill establishes new requirements for reporting, collecting, and sharing information about suspicious orders.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6779 Introduced in House (IH)]

<DOC>






115th CONGRESS
  2d Session
                                H. R. 6779

To amend the Controlled Substances Act to require the Drug Enforcement 
    Administration to report certain information on distribution of 
                    opioids, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 12, 2018

   Mr. Buck introduced the following bill; which was referred to the 
 Committee on Energy and Commerce, and in addition to the Committee on 
   the Judiciary, for a period to be subsequently determined by the 
  Speaker, in each case for consideration of such provisions as fall 
           within the jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
To amend the Controlled Substances Act to require the Drug Enforcement 
    Administration to report certain information on distribution of 
                    opioids, and for other purposes.

    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 ``Using Data to Prevent Opioid 
Diversion Act of 2018''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) In 2016, there were nearly 64,000 drug overdose deaths 
        in the United States. More than 42,000 of these deaths were 
        opioid-related.
            (2) The regulations promulgated under the Controlled 
        Substances Act (21 U.S.C. 801 et seq.) require drug 
        manufacturers and distributors to--
                    (A) provide effective controls against the 
                diversion of controlled substances;
                    (B) detect and disclose suspicious orders to the 
                Drug Enforcement Administration; and
                    (C) keep complete and accurate records relating to 
                the manufacture or distribution of controlled 
                substances.
            (3) Despite the requirements described in paragraph (2), it 
        has been publicly reported that between 2006 and 2016, nearly 
        21,000,000 opioids were distributed to 2 pharmacies in 
        Williamson, West Virginia, which has a population of 
        approximately 3,000. It has been further reported that between 
        2007 and 2008, nearly 9,000,000 pills were distributed to a 
        single pharmacy in Kermit, West Virginia, which has a 
        population of 392.
            (4) Similarly, it has been publicly reported that 
        780,000,000 oxycodone and hydrocodone pills were distributed to 
        pharmacies throughout West Virginia between 2007 and 2012. In 
        the same period, more than 1,700 people in the State died from 
        overdoses of these 2 substances.
            (5) Drug manufacturers and distributors are required to 
        report the sale, delivery or other disposal of narcotics to the 
        Drug Enforcement Administration through the Automated Reports 
        and Consolidated Orders System.
            (6) Notwithstanding the reporting requirement described in 
        paragraph (5), the Drug Enforcement Administration does not 
        disclose the total quantity and type of opioids distributed to 
        a single pharmacy or practitioner with those manufacturers and 
        distributors who are required to input information into the 
        Automated Reports and Consolidated Orders System. This creates 
        a barrier to identifying and stopping potentially suspicious 
        orders.
            (7) Although manufacturers and distributors are already 
        required to provide effective controls against the diversion of 
        controlled substances, this lack of data sharing may create a 
        barrier to better identifying and stopping potentially 
        suspicious orders.
            (8) On an annual basis, the Attorney General of the United 
        States is statutorily required to share the controlled 
        substance or substances in schedule II that have the highest 
        rates of abuse and to prepare and make available reports on the 
        distribution patterns of such substances, with State 
        regulatory, licensing, and law enforcement agencies. The 
        Attorney General of the United States has entered into data 
        sharing agreements with the attorneys general of the vast 
        majority of States, Puerto Rico, and the District of Colombia 
        to share, pursuant to State law and policy, data obtained from 
        State prescription drug monitoring programs and other sources.
            (9) To further reduce barriers associated with identifying 
        suspicious patterns and stopping the diversion of opioids, the 
        remaining States and territories of the United States should 
        enter into similar agreements with, and to the greatest extent 
        practical share data obtained from State prescription drug 
        monitoring programs with, the Attorney General of the United 
        States.

SEC. 3. PURPOSE.

    (a) In General.--The purpose of this Act is to provide drug 
manufacturers and distributors with access to anonymized information 
through the Automated Reports and Consolidated Orders System to help 
drug manufacturers and distributors identify, report, and stop 
suspicious orders of opioids and reduce diversion rates.
    (b) Rule of Construction.--Nothing in this Act should be construed 
to absolve a drug manufacturer, drug distributor, or other Drug 
Enforcement Administration registrant from the responsibility of the 
manufacturer, distributor, or other registrant to--
            (1) identify, stop, and report suspicious orders; or
            (2) maintain effective controls against diversion in 
        accordance with section 303 of the Controlled Substances Act 
        (21 U.S.C. 823) or any successor law or associated regulation.

SEC. 4. AMENDMENTS.

    (a) Records and Reports of Registrants.--Section 307 of the 
Controlled Substances Act (21 U.S.C. 827) is amended--
            (1) by redesignating subsections (f), (g), and (h) as 
        subsections (g), (h), and (i), respectively;
            (2) by inserting after subsection (e) the following:
    ``(f)(1) The Attorney General shall, not less frequently than 
quarterly, make the following information available to manufacturer and 
distributor registrants through the Automated Reports and Consolidated 
Orders System, or any subsequent automated system developed by the Drug 
Enforcement Administration to monitor selected controlled substances:
            ``(A) The total number of distributor registrants that 
        distribute controlled substances to a pharmacy or practitioner 
        registrant, aggregated by the name and address of each pharmacy 
        and practitioner registrant.
            ``(B) The total quantity and type of opioids distributed, 
        listed by Administration Controlled Substances Code Number, to 
        each pharmacy and practitioner registrant described in 
        subparagraph (A).
    ``(2) The information required to be made available under paragraph 
(1) shall be made available not later than the 15th day of the first 
month following the quarter to which the information relates.
    ``(3)(A) All registered manufacturers and distributors shall be 
responsible for reviewing the information made available by the 
Attorney General under this subsection.
    ``(B) In determining whether to initiate proceedings under this 
title against a registered manufacturer or distributor based on the 
failure of the registrant to maintain effective controls against 
diversion or otherwise comply with the requirements of this title or 
the regulations issued thereunder, the Attorney General may take into 
account that the information made available under this subsection was 
available to the registrant.''; and
            (3) by inserting after subsection (i), as so redesignated, 
        the following:
    ``(j) All of the reports required under this section shall be 
provided in an electronic format.''.
    (b) Cooperative Arrangements.--Section 503 of the Controlled 
Substances Act (21 U.S.C. 873) is amended--
            (1) by striking subsection (c) and inserting the following:
    ``(c)(1) The Attorney General shall, once every 6 months, prepare 
and make available to regulatory, licensing, attorneys general, and law 
enforcement agencies of States a standardized report containing 
descriptive and analytic information on the actual distribution 
patterns, as gathered through the Automated Reports and Consolidated 
Orders System, or any subsequent automated system, pursuant to section 
307 and which includes detailed amounts, outliers, and trends of 
distributor and pharmacy registrants, in such States for the controlled 
substances contained in schedule II, which, in the discretion of the 
Attorney General, are determined to have the highest abuse.
    ``(2) If the Attorney General publishes the report described in 
paragraph (1) once every 6 months as required under paragraph (1), 
nothing in this subsection shall be construed to bring an action in any 
court to challenge the sufficiency of the information or to compel the 
Attorney General to produce any documents or reports referred to in 
this subsection.''.
    (c) Civil and Criminal Penalties.--Section 402 of the Controlled 
Substances Act (21 U.S.C. 842) is amended--
            (1) in subsection (a)--
                    (A) in paragraph (15), by striking ``or'' at the 
                end;
                    (B) in paragraph (16), by striking the period at 
                the end and inserting ``; or''; and
                    (C) by inserting after paragraph (16) the 
                following:
            ``(17) in the case of a registered manufacturer or 
        distributor of opioids, to fail to review the most recent 
        information, directly related to the customers of the 
        manufacturer or distributor, made available by the Attorney 
        General in accordance with section 307(f).''; and
            (2) in subsection (c)--
                    (A) in paragraph (1), by striking subparagraph (B) 
                and inserting the following:
    ``(B)(i) Except as provided in clause (ii), in the case of a 
violation of paragraph (5), (10), or (17) of subsection (a), the 
penalty shall not exceed $10,000.
    ``(ii) In the case of a violation described in clause (i) committed 
by a registered manufacturer or distributor of opioids and related to 
the reporting of suspicious orders for opioids, failing to maintain 
effective controls against diversion of opioids, or failing to review 
the most recent information made available by the Attorney General in 
accordance with section 307(f), the penalty shall not exceed 
$100,000.''; and
                    (B) in paragraph (2)--
                            (i) in subparagraph (A), by inserting ``or 
                        (D)'' after ``subparagraph (B)''; and
                            (ii) by adding at the end the following:
    ``(D) In the case of a violation described in subparagraph (A) that 
was a violation of paragraph (5), (10), or (17) of subsection (a) 
committed by a registered manufacturer or distributor of opioids that 
relates to the reporting of suspicious orders for opioids, failing to 
maintain effective controls against diversion of opioids, or failing to 
review the most recent information made available by the Attorney 
General in accordance with section 307(f), the criminal fine under 
title 18, United States Code, shall not exceed $500,000.''.

SEC. 5. REPORT.

    Not later than 1 year after the date of enactment of this Act, the 
Attorney General shall submit to Congress a report that provides 
information about how the Attorney General is using data in the 
Automation of Reports and Consolidated Orders System to identify and 
stop suspicious activity, including whether the Attorney General is 
looking at aggregate orders from individual pharmacies to multiple 
distributors that in total are suspicious, even if no individual order 
rises to the level of a suspicious order to a given distributor.

SEC. 6. IMPROVEMENTS TO PREVENT DRUG DIVERSION.

    (a) Definition.--
            (1) In general.--Section 102 of the Controlled Substances 
        Act (21 U.S.C. 802) is amended by adding at the end the 
        following:
            ``(57) The term `suspicious order' includes--
                    ``(A) an order of a controlled substance of unusual 
                size;
                    ``(B) an order of a controlled substance deviating 
                substantially from a normal pattern;
                    ``(C) orders of controlled substances of unusual 
                frequency; and
                    ``(D) an order or pattern of orders of a controlled 
                substance that meet such other criteria as are 
                established by the Attorney General by regulation.''.
            (2) Regulations.--Not later than 1 year after the date of 
        enactment of this Act, the Attorney General shall promulgate 
        regulations under paragraph (57)(D) of section 102 of the 
        Controlled Substances Act, as added by paragraph (1) of this 
        subsection.
    (b) Suspicious Orders.--Part C of the Controlled Substances Act (21 
U.S.C. 821 et seq.) is amended by adding at the end the following:

``SEC. 312. SUSPICIOUS ORDERS.

    ``(a) Reporting.--Each registrant shall--
            ``(1) design and operate a system to identify suspicious 
        orders for the registrant;
            ``(2) ensure that the system designed and operated under 
        paragraph (1) by the registrant complies with applicable 
        Federal and State privacy laws; and
            ``(3) upon discovering a suspicious order or series of 
        orders, notify the Administrator of the Drug Enforcement 
        Administration and the Special Agent in Charge of the Division 
        Office of the Drug Enforcement Administration for the area in 
        which the registrant is located or conducts business.
    ``(b) Suspicious Order Database.--
            ``(1) In general.--Not later than 1 year after the date of 
        enactment of this section, the Attorney General shall establish 
        a centralized database for collecting reports of suspicious 
        orders.
            ``(2) Satisfaction of reporting requirements.--If a 
        registrant reports a suspicious order to the centralized 
        database established under paragraph (1), the registrant shall 
        be considered to have complied with the requirement under 
        subsection (a)(3) to notify the Administrator of the Drug 
        Enforcement Administration and the Special Agent in Charge of 
        the Division Office of the Drug Enforcement Administration for 
        the area in which the registrant is located or conducts 
        business.
    ``(c) Sharing Information With the States.--
            ``(1) In general.--The Attorney General shall prepare and 
        make available information regarding suspicious orders in a 
        State, including information in the database established under 
        subsection (b)(1), to the point of contact for purposes of 
        administrative, civil, and criminal oversight relating to the 
        diversion of controlled substances for the State, as designated 
        by the Governor or chief executive officer of the State.
            ``(2) Timing.--The Attorney General shall provide 
        information in accordance with paragraph (1) within a 
        reasonable period of time after obtaining the information.
            ``(3) Coordination.--In establishing the process for the 
        provision of information under this subsection, the Attorney 
        General shall coordinate with States to ensure that the 
        Attorney General has access to information, as permitted under 
        State law, possessed by the States relating to prescriptions 
        for controlled substances that will assist in enforcing Federal 
        law.''.
    (c) Reports to Congress.--
            (1) Definition.--In this subsection, the term ``suspicious 
        order'' has the meaning given that term in section 102 of the 
        Controlled Substances Act, as amended by this Act.
            (2) One time report.--Not later than 1 year after the date 
        of enactment of this Act, the Attorney General shall submit to 
        Congress a report on the reporting of suspicious orders, which 
        shall include--
                    (A) a description of the centralized database 
                established under section 312 of the Controlled 
                Substances Act, as added by this section, to collect 
                reports of suspicious orders;
                    (B) a description of the system and reports 
                established under section 312 of the Controlled 
                Substances Act, as added by this section, to share 
                information with States;
                    (C) information regarding how the Attorney General 
                used reports of suspicious orders before the date of 
                enactment of this Act and after the date of enactment 
                of this Act, including how the Attorney General 
                received the reports and what actions were taken in 
                response to the reports; and
                    (D) descriptions of the data analyses conducted on 
                reports of suspicious orders to identify, analyze, and 
                stop suspicious activity.
            (3) Additional reports.--Not later than 1 year after the 
        date of enactment of this Act, and annually thereafter until 
        the date that is 5 years after the date of enactment of this 
        Act, the Attorney General shall submit to Congress a report 
        providing, for the previous year--
                    (A) the number of reports of suspicious orders;
                    (B) a summary of actions taken in response to 
                reports, in the aggregate, of suspicious orders; and
                    (C) a description of the information shared with 
                States based on reports of suspicious orders.
                                 <all>