[Congressional Record Volume 162, Number 34 (Wednesday, March 2, 2016)]
[Senate]
[Pages S1233-S1234]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SA 3397. Mr. HATCH (for himself and Mr. Whitehouse) submitted an
amendment intended to be proposed to amendment SA 3378 proposed by Mr.
Grassley (for himself, Mr. Leahy, Mr. Whitehouse, Mr. Portman, Ms.
Klobuchar, Ms. Ayotte, Mr. Graham, Mr. Coons, Mr. Cornyn, and Mr.
Durbin) to the bill S. 524, to authorize the Attorney General to award
grants to address the national epidemics of prescription opioid abuse
and heroin use; which was ordered to lie on the table; as follows:
At the end, add the following:
TITLE VIII--ENSURING PATIENT ACCESS AND EFFECTIVE DRUG ENFORCEMENT ACT
SEC. 801. SHORT TITLE.
This title may be cited as the ``Ensuring Patient Access
and Effective Drug Enforcement Act of 2016''.
SEC. 802. 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;
[[Page S1234]]
``(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. 803. 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.
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