[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 483 Reported in Senate (RS)]

<DOC>





                                                       Calendar No. 368
114th CONGRESS
  2d Session
                                 S. 483

 To improve enforcement efforts related to prescription drug diversion 
                   and abuse, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           February 12, 2015

Mr. Hatch (for himself, Mr. Whitehouse, Mr. Rubio, Mr. Vitter, and Mr. 
   Cassidy) introduced the following bill; which was read twice and 
               referred to the Committee on the Judiciary

                           February 11, 2016

              Reported by Mr. Grassley, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 A BILL


 
 To improve enforcement efforts related to prescription drug diversion 
                   and abuse, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``Ensuring Patient Access and 
Effective Drug Enforcement Act of 2015''.</DELETED>

<DELETED>SEC. 2. REGISTRATION PROCESS UNDER CONTROLLED SUBSTANCES 
              ACT.</DELETED>

<DELETED>    (a) Definitions.--</DELETED>
        <DELETED>    (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:</DELETED>
<DELETED>    ``(i) 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.''.</DELETED>
        <DELETED>    (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--</DELETED>
                <DELETED>    (A) by striking ``(d) The Attorney 
                General'' and inserting ``(d)(1) The Attorney 
                General''; and</DELETED>
                <DELETED>    (B) by adding at the end the 
                following:</DELETED>
<DELETED>    ``(2) In this subsection, the phrase `imminent danger to 
the public health or safety' means that, in the absence of an immediate 
suspension order, controlled substances will continue to be distributed 
or dispensed by a registrant who knows or should know through 
fulfilling the obligations of the registrant under this Act--</DELETED>
        <DELETED>    ``(A) the dispensing is outside the usual course 
        of professional practice;</DELETED>
        <DELETED>    ``(B) the distribution or dispensing poses a 
        present or foreseeable risk of adverse health consequences or 
        death due to the abuse or misuse of the controlled substances; 
        or</DELETED>
        <DELETED>    ``(C) the controlled substances will continue to 
        be diverted outside of legitimate distribution 
        channels.''.</DELETED>
<DELETED>    (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--</DELETED>
        <DELETED>    (1) by striking the last two sentences;</DELETED>
        <DELETED>    (2) by striking ``(c) Before'' and inserting 
        ``(c)(1) Before''; and</DELETED>
        <DELETED>    (3) by adding at the end the following:</DELETED>
<DELETED>    ``(2) An order to show cause under paragraph (1) shall--
</DELETED>
        <DELETED>    ``(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;</DELETED>
        <DELETED>    ``(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</DELETED>
        <DELETED>    ``(C) notify the applicant or registrant of the 
        opportunity to submit a corrective action plan on or before the 
        date of appearance.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(5) The requirements of this subsection shall not apply 
to the issuance of an immediate suspension order under subsection 
(d).''.</DELETED>

<DELETED>SEC. 3. REPORT TO CONGRESS ON EFFECTS OF LAW ENFORCEMENT 
              ACTIVITIES ON PATIENT ACCESS TO MEDICATIONS.</DELETED>

<DELETED>    (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 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--</DELETED>
        <DELETED>    (1) obstacles to legitimate patient access to 
        controlled substances;</DELETED>
        <DELETED>    (2) issues with diversion of controlled 
        substances; and</DELETED>
        <DELETED>    (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.</DELETED>
<DELETED>    (b) Consultation.--The report under subsection (a) shall 
incorporate feedback and recommendations from the following:</DELETED>
        <DELETED>    (1) Patient groups.</DELETED>
        <DELETED>    (2) Pharmacies.</DELETED>
        <DELETED>    (3) Drug manufacturers.</DELETED>
        <DELETED>    (4) Common or contract carriers and 
        warehousemen.</DELETED>
        <DELETED>    (5) Hospitals, physicians, and other health care 
        providers.</DELETED>
        <DELETED>    (6) State attorneys general.</DELETED>
        <DELETED>    (7) Federal, State, local, and tribal law 
        enforcement agencies.</DELETED>
        <DELETED>    (8) Health insurance providers and entities that 
        provide pharmacy benefit management services on behalf of a 
        health insurance provider.</DELETED>
        <DELETED>    (9) Wholesale drug distributors.</DELETED>
        <DELETED>    (10) Veterinarians.</DELETED>

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.
                                                       Calendar No. 368

114th CONGRESS

  2d Session

                                 S. 483

_______________________________________________________________________

                                 A BILL

 To improve enforcement efforts related to prescription drug diversion 
                   and abuse, and for other purposes.

_______________________________________________________________________

                           February 11, 2016

                       Reported with an amendment