[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4069 Introduced in House (IH)]
113th CONGRESS
2d Session
H. R. 4069
To improve enforcement efforts related to prescription drug diversion
and abuse, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
February 18, 2014
Mr. Marino (for himself and Mrs. Blackburn) introduced the following
bill; which was referred to the Committee on Energy and Commerce, and
in addition to the Committee on the Judiciary, for a period to be
subsequently determined by the Speaker, in each case for consideration
of such provisions as fall within the jurisdiction of the committee
concerned
_______________________________________________________________________
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,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Ensuring Patient Access and
Effective Drug Enforcement Act of 2013''.
SEC. 2. REGISTRATION PROCESS UNDER CONTROLLED SUBSTANCES ACT.
(a) Definitions.--
(1) 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 `consistent with the public
health and safety' means having a substantial relationship to this
Act's purpose of preventing diversion and abuse of controlled
substances.''.
(2) Imminent danger.--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 term `imminent danger' means a
significant and present risk of death or serious bodily harm that is
more likely than not to occur in the absence of an immediate suspension
order.''.
(b) Criminal Background Checks and Drug Testing for Employees With
Access to Controlled Substances.--
(1) Requirements.--Section 303 of the Controlled Substances
Act (21 U.S.C. 823) is amended by inserting before subsection
(j) (as added by subsection (a)(1)) the following:
``(i)(1) The Attorney General shall require all registrants under
subsections (a), (b), (d), or (e), as a condition of such
registration--
``(A) to obtain a criminal background check on each of the
registrant's employees who has or will have access to facility
areas where controlled substances under the registrant's
possession or control are stored, such as a cage, vault, or
safe; and
``(B) to perform drug testing on each such employee in
accordance with Federal and State law.
``(2) The criminal background checks required by paragraph (1)
shall be obtained--
``(A) periodically, but not more frequently than every 2
years, for all employees of the registrant who are described in
paragraph (1)(A); and
``(B) at the time of hire, for such employees who are hired
after the date of enactment of the Ensuring Patient Access and
Effective Drug Enforcement Act of 2013.
``(3) The term `drug testing' means testing designed to detect the
illegal use of a controlled substance.''.
(2) Conforming change.--Section 304(a) of the Controlled
Substances Act (21 U.S.C. 823(a)) is amended--
(A) in paragraph (4), by striking ``or'' at the
end;
(B) in paragraph (5), by striking the period at the
end and inserting ``; or''; and
(C) by adding at the end the following:
``(6) has failed to comply with the requirements under
section 303(i) (relating to criminal background checks and drug
testing).''.
(3) Alternative civil penalty for failure to comply with
criminal background check and drug testing requirements.--
(A) Prohibited act.--Section 402(a) of the
Controlled Substances Act (21 U.S.C. 842(a)) is
amended--
(i) in paragraph (14), by striking ``or''
at the end;
(ii) in paragraph (15), by striking the
period at the end and inserting ``; or''; and
(iii) by inserting after paragraph (15) the
following:
``(16) who is a registrant to fail to comply with the
requirements under section 303(i) (relating to criminal
background checks and drug testing);''.
(B) Maximum civil penalty of $10,000.--Subsection
(c)(1)(B) of the Controlled Substances Act (21 U.S.C.
842(c)(1)(B)) is amended by striking ``paragraph (5) or
(10)'' and inserting ``paragraph (5), (10), or (16)''.
(4) Regulations, guidance.--The Attorney General of the
United States shall finalize such regulations and guidance as
the Attorney General deems necessary to carry out the
amendments made by this subsection.
(5) Applicability.--The amendments made by this subsection
shall apply beginning on the date that is 2 years after the
date of enactment of this Act.
(c) Opportunity To Submit Corrective Action Plan Prior to
Revocation or Suspension.--Section 304(c) of the Controlled Substances
Act (21 U.S.C. 824(c)) is amended--
(1) by striking ``(c) Before'' and inserting ``(c)(1)
Before''; and
(2) by adding at the end the following:
``(2) Before revoking or suspending a registration pursuant to
section 303, the Attorney General shall--
``(A) provide--
``(i) notice to the registrant of the grounds for
revocation or suspension; and
``(ii) in the case of any such grounds consisting
of a violation of law, a specific citation to such law;
``(B) give the registrant an opportunity to submit a
corrective action plan within a reasonable period of time to
demonstrate how the registrant plans to correct the grounds for
revocation or suspension; and
``(C) determine whether--
``(i) in light of the plan, revocation or
suspension proceedings should be discontinued or
deferred; or
``(ii) additional changes need to be made in the
corrective action plan.''.
SEC. 3. COMBATING PRESCRIPTION DRUG ABUSE WORKING GROUP.
(a) Establishment.--There is established the Combating Prescription
Drug Abuse Working Group (referred to in this section as the ``Working
Group'').
(b) Membership.--
(1) Appointment.--
(A) In general.--Not later than 180 days after the
date of the enactment of this Act, the President shall
appoint each member of the Working Group.
(B) Composition.--The Working Group shall be
composed of not more than 20 members and shall include
at least 1 and not more than 3 of each of the
following:
(i) Public policy experts.
(ii) Representatives of the Drug
Enforcement Administration.
(iii) Representatives of the Food and Drug
Administration.
(iv) Representatives of the Office of
National Drug Control Policy.
(v) Representatives of patient groups.
(vi) Representatives of pharmacies.
(vii) Representatives of manufacturers of
drugs.
(viii) Representatives of wholesale
distributors of drugs.
(ix) Representatives of hospitals,
physicians, and other health care providers.
(x) Representatives of State attorneys
general.
(xi) Representatives of law enforcement
officials, including local law enforcement
officials.
(xii) Representatives of health benefits
plans and entities that provide pharmacy
benefits management services on behalf of a
health benefits plans.
(2) Co-chairs.--The co-chairs shall be elected by the
members of the Working Group. The Working Group shall select
for election from the members of the Group two individuals, of
whom--
(A) one shall be a representative of the Federal
Government or a State government; and
(B) one shall be a representative of a non-
governmental entity.
(3) Term; vacancies.--Each member shall be appointed for
the life of the Working Group. Any vacancy in the Working Group
shall not affect the powers of the Working Group and shall be
filled in the same manner in which the original appointment was
made.
(4) Pay prohibited.--Members of the Working Group shall
serve without pay.
(c) Meetings.--The Working Group shall meet at the call of the co-
chairs. The Working Group shall conduct at least two public meetings,
at which the Working Group shall provide opportunity for public
comment.
(d) Duties of the Working Group.--
(1) In general.--The Working Group shall--
(A) review and report to Congress on Federal
initiatives with respect to efforts to reduce
prescription drug diversion and abuse;
(B) identify gaps and opportunities with respect to
ensuring the safe use of prescription drugs with the
potential for diversion and abuse;
(C) examine recommendations to transfer one or more
controlled substances from schedule III to schedule II
under the Controlled Substances Act (21 U.S.C. 801 et
seq.) to evaluate--
(i) the effectiveness of such a transfer in
reducing diversion and abuse; and
(ii) any effect of such a transfer on
access to prescription drugs for legitimate
medical purposes; and
(D) make recommendations on specific ways to reduce
the diversion and abuse of prescription drugs.
(2) Report.--
(A) In general.--Not later than one year after the
date of the enactment of this Act, the Working Group
shall issue a report to Congress that describes the
efforts of the Working Group to prevent or reduce
prescription drug diversion and abuse to ensure that
patients continue to have access to medications.
(B) Recommendations.--The report described in
subparagraph (A) shall include specific recommendations
for the Drug Enforcement Administration, the Food and
Drug Administration, and other Federal and State
agencies, as appropriate, and shall address the
following topics:
(i) Systems for prescription drug
monitoring.
(ii) Illegal prescription drug Internet
sites and facilities that distribute and fill
prescriptions indiscriminately.
(iii) Facilitating proper disposal of
prescription drugs.
(iv) Identifying active geographic areas in
which prescription drug abuse is prevalent.
(v) Ensuring access to prescription drugs
for legitimate medical purposes.
(vi) Improving collaboration among Federal
agencies, especially the Drug Enforcement
Administration and the Food and Drug
Administration, for purposes of coordinating
prevention and enforcement efforts to reduce
prescription drug diversion and abuse.
(vii) Improving collaboration among Federal
agencies and State agencies for purposes of
coordinating prevention and enforcement efforts
to reduce prescription drug diversion and
abuse.
(viii) The resource needs for law
enforcement with respect to prescription drug
abuse.
(ix) The need for education of providers,
patients, parents, and youth on prescription
drug abuse.
(x) Development of abuse-resistant
prescription drug products.
(xi) Recommendations for reducing
robberies, burglaries, and cargo theft of
prescription drugs.
(e) Powers of the Working Group.--
(1) Hearings.--The Working Group may, for the purpose of
carrying out this section, hold hearings, sit and act at times
and places, take testimony, and receive evidence as the Working
Group considers necessary.
(2) Information from federal agencies.--The Working Group
may secure directly from any Federal department or agency such
information as the Working Group considers necessary to carry
out this section. Upon the request of the co-chairs of the
Working Group, the head of such department or agency shall
furnish such information to the Working Group in a timely
manner.
(f) Termination of the Working Group.--The Working Group shall
terminate two years after the date on which the members are appointed
under subsection (b).
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