[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4709 Referred in Senate (RFS)]
113th CONGRESS
2d Session
H. R. 4709
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 30, 2014
Received; read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
AN ACT
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,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Ensuring Patient Access and
Effective Drug Enforcement Act of 2014''.
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:
``(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.''.
(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, in the absence of an immediate suspension
order, controlled substances--
``(A) will continue to be intentionally distributed or
dispensed--
``(i) outside the usual course of professional
practice; or
``(ii) in a manner that poses a present or
foreseeable risk of serious adverse health consequences
or death; or
``(B) will continue to be intentionally diverted outside of
legitimate distribution channels.''.
(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 two sentences in such subsection;
(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 no less than thirty 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. 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 ON EFFECTS OF LAW ENFORCEMENT ACTIVITIES ON
PATIENT ACCESS TO MEDICATIONS.
(a) In General.--Not later than one 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, and in consultation
with the Administrator of the Drug Enforcement Administration and the
Director of National Drug Control Policy, shall submit a report to the
Committees 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; and
(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.
(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.
Passed the House of Representatives July 29, 2014.
Attest:
KAREN L. HAAS,
Clerk.