[Congressional Record (Bound Edition), Volume 162 (2016), Part 3]
[Senate]
[Pages 3456-3457]
[From the U.S. Government Publishing Office, www.gpo.gov]




   ENSURING PATIENT ACCESS AND EFFECTIVE DRUG ENFORCEMENT ACT OF 2015

  Mr. McCONNELL. Mr. President, I ask unanimous consent that the Senate 
proceed to the immediate consideration of Calendar No. 368, S. 483.
  The PRESIDING OFFICER. The clerk will report the bill by title.
  The legislative clerk read as follows:

       A bill (S. 483) to improve enforcement efforts related to 
     prescription drug diversion and abuse, and for other 
     purposes.

  There being no objection, the Senate proceeded to consider the bill, 
which had been reported from the Committee on the Judiciary, with an 
amendment to strike all after the enacting clause and insert in lieu 
thereof the following:

     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.

[[Page 3457]]

       ``(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.

  Mr. McCONNELL. Mr. President, I ask unanimous consent that the 
committee-reported substitute amendment be agreed to, the bill, as 
amended, be read a third time and passed, and the motion to reconsider 
be considered made and laid upon the table.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The committee-reported amendment in the nature of a substitute was 
agreed to.
  The bill (S. 483), as amended, was ordered to be engrossed for a 
third reading, was read the third time, and passed.

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