Ensuring Patient Access and Effective Drug Enforcement Act of 2016

Summary: (This measure has not been amended since it was reported to the Senate on February 11, 2016.  Ensuring Patient Access and Effective Drug Enforcement Act of 2016 (Sec. 2) This bill amends the Controlled Substances Act to define phrases related to the Drug Enforcement Administration's (DEA's) authority to register manufacturers, distributors, and dispensers of controlled substances. Currently, the DEA registers a controlled substances manufacturer, distributor, or dispenser if it is in the public interest after considering certain factors, including factors relevant to and consistent with the public health and safety. This bill defines "factors as may be relevant to and consistent with the public health and safety" to mean factors relevant to and consistent with the specified purposes of the Controlled Substances Act. Additionally, current law allows the DEA to immediately suspend a registration to prevent imminent danger to the public health and safety. This bill defines "imminent danger to the public health and safety" to mean an immediate threat of death, serious bodily harm, or abuse of a controlled substance due to a registrant's failure to maintain effective controls against diversion. The bill revises and expands the required elements of an order to show cause issued by the DEA before it denies, revokes, or suspends a registration for a Controlled Substances Act violation. An order to show cause must specifically state the legal basis for the action and notify the registrant of the opportunity to submit a corrective action plan.  (Sec. 3) The Food and Drug Administration, the Substance Abuse and Mental Health Services Administration, the Agency for Research and Quality, and the Centers for Disease Control and Prevention, in coordination with the DEA, must report to Congress on:  obstacles to legitimate patient access to controlled substances;  diversion of controlled substances;  how collaboration between law enforcement agencies and the pharmaceutical industry can benefit patients and prevent diversion and abuse of controlled substances;  the availability of and gaps in medical education, training opportunities, and comprehensive clinical guidance for pain management and opioid prescribing;  enhancements to prescription drug monitoring programs; and  improvements to prescription opioid reporting requirements. 

SECTION 1. SHORT TITLE.
    This Act may be cited as the ``Ensuring Patient Access and 
Effective Drug Enforcement Act of 2016''.
SEC. 2. REGISTRATION PROCESS UNDER CONTROLLED SUBSTANCES ACT.
    (a) Definitions.--
        (1) Factors as may be relevant to and consistent with the 
    public health and safety.--Section 303 of the Controlled Substances 
    Act (21 U.S.C. 823) is amended by adding at the end the following:
    ``(j) In this section, the phrase `factors as may be relevant to 
and consistent with the public health and safety' means factors that 
are relevant to and consistent with the findings contained in section 
101.''.
        (2) Imminent danger to the public health or safety.--Section 
    304(d) of the Controlled Substances Act (21 U.S.C. 824(d)) is 
    amended--
            (A) by striking ``(d) The Attorney General'' and inserting 
        ``(d)(1) The Attorney General''; and
            (B) by adding at the end the following:
    ``(2) In this subsection, the phrase `imminent danger to the public 
health or safety' means that, due to the failure of the registrant to 
maintain effective controls against diversion or otherwise comply with 
the obligations of a registrant under this title or title III, there is 
a substantial likelihood of an immediate threat that death, serious 
bodily harm, or abuse of a controlled substance will occur in the 
absence of an immediate suspension of the registration.''.
    (b) Opportunity To Submit Corrective Action Plan Prior to 
Revocation or Suspension.--Subsection (c) of section 304 of the 
Controlled Substances Act (21 U.S.C. 824) is amended--
        (1) by striking the last three sentences;
        (2) by striking ``(c) Before'' and inserting ``(c)(1) Before''; 
    and
        (3) by adding at the end the following:
    ``(2) An order to show cause under paragraph (1) shall--
        ``(A) contain a statement of the basis for the denial, 
    revocation, or suspension, including specific citations to any laws 
    or regulations alleged to be violated by the applicant or 
    registrant;
        ``(B) direct the applicant or registrant to appear before the 
    Attorney General at a time and place stated in the order, but not 
    less than 30 days after the date of receipt of the order; and
        ``(C) notify the applicant or registrant of the opportunity to 
    submit a corrective action plan on or before the date of 
    appearance.
    ``(3) Upon review of any corrective action plan submitted by an 
applicant or registrant pursuant to paragraph (2), the Attorney General 
shall determine whether denial, revocation, or suspension proceedings 
should be discontinued, or deferred for the purposes of modification, 
amendment, or clarification to such plan.
    ``(4) Proceedings to deny, revoke, or suspend shall be conducted 
pursuant to this section in accordance with subchapter II of chapter 5 
of title 5, United States Code. Such proceedings shall be independent 
of, and not in lieu of, criminal prosecutions or other proceedings 
under this title or any other law of the United States.
    ``(5) The requirements of this subsection shall not apply to the 
issuance of an immediate suspension order under subsection (d).''.
SEC. 3. REPORT TO CONGRESS.
    (a) In General.--Not later than 1 year after the date of enactment 
of this Act, the Secretary of Health and Human Services, acting through 
the Commissioner of Food and Drugs, the Administrator of the Substance 
Abuse and Mental Health Services Administration, the Director of the 
Agency for Healthcare Research and Quality, and the Director of the 
Centers for Disease Control and Prevention, in coordination with the 
Administrator of the Drug Enforcement Administration and in 
consultation with the Secretary of Defense and the Secretary of 
Veterans Affairs, shall submit a report to the Committee on the 
Judiciary of the House of Representatives, the Committee on Energy and 
Commerce of the House of Representatives, the Committee on the 
Judiciary of the Senate, and the Committee on Health, Education, Labor, 
and Pensions of the Senate identifying--
        (1) obstacles to legitimate patient access to controlled 
    substances;
        (2) issues with diversion of controlled substances;
        (3) how collaboration between Federal, State, local, and tribal 
    law enforcement agencies and the pharmaceutical industry can 
    benefit patients and prevent diversion and abuse of controlled 
    substances;
        (4) the availability of medical education, training 
    opportunities, and comprehensive clinical guidance for pain 
    management and opioid prescribing, and any gaps that should be 
    addressed;
        (5) beneficial enhancements to State prescription drug 
    monitoring programs, including enhancements to require 
    comprehensive prescriber input and to expand access to the programs 
    for appropriate authorized users; and
        (6) steps to improve reporting requirements so that the public 
    and Congress have more information regarding prescription opioids, 
    such as the volume and formulation of prescription opioids 
    prescribed annually, the dispensing of such prescription opioids, 
    and outliers and trends within large data sets.
    (b) Consultation.--The report under subsection (a) shall 
incorporate feedback and recommendations from the following:
        (1) Patient groups.
        (2) Pharmacies.
        (3) Drug manufacturers.
        (4) Common or contract carriers and warehousemen.
        (5) Hospitals, physicians, and other health care providers.
        (6) State attorneys general.
        (7) Federal, State, local, and tribal law enforcement agencies.
        (8) Health insurance providers and entities that provide 
    pharmacy benefit management services on behalf of a health 
    insurance provider.
        (9) Wholesale drug distributors.
        (10) Veterinarians.
        (11) Professional medical societies and boards.
        (12) State and local public health authorities.
        (13) Health services research organizations.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.