[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6491 Introduced in House (IH)]

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115th CONGRESS
  2d Session
                                H. R. 6491

To amend the Controlled Substances Act to require the Drug Enforcement 
Administration to report certain information on distribution of opioids 
 to manufacturers and distributors to help identify, report, and stop 
suspicious orders of opioids and reduce diversion rates, and for other 
                               purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 24, 2018

  Ms. Castor of Florida (for herself and Mr. McKinley) 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 
 to manufacturers and distributors to help identify, report, and stop 
suspicious orders of opioids and reduce diversion rates, 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. PROVISION AND REVIEW OF AUTOMATED REPORTS AND CONSOLIDATED 
              ORDERS SYSTEMS INFORMATION.

    (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; and
            (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 manufacturers 
and distributors registered under this title 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 distributors registered under 
        this title that distribute controlled substances to a pharmacy 
        or practitioner registered under section 303(f), 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 registered under section 303(f).
    ``(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 manufacturers and distributors registered under this 
title 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 manufacturer or distributor registered under this title 
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.
    ``(4) All of the reports required under this subsection shall be 
provided in 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. Such reports shall include 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 authorize an action to 
be brought in any court to challenge the sufficiency of the information 
in the report or to compel the Attorney General to produce any 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 manufacturer or distributors of 
        opioids registered under this title, 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 manufacturer or distributor of opioids registered under this title 
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 manufacturer or distributor of opioids registered under 
this title 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. 4. 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. 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.
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