[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