[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[S. 2862 Introduced in Senate (IS)]
113th CONGRESS
2d Session
S. 2862
To amend the Controlled Substances Act with respect to drug scheduling
recommendations by the Secretary of Health and Human Services, and with
respect to registration of manufacturers and distributors seeking to
conduct clinical testing, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
September 18, 2014
Mr. Hatch (for himself and Mr. Whitehouse) introduced the following
bill; which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To amend the Controlled Substances Act with respect to drug scheduling
recommendations by the Secretary of Health and Human Services, and with
respect to registration of manufacturers and distributors seeking to
conduct clinical testing, 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 ``Regulatory Transparency, Patient
Access, and Effective Drug Enforcement Act of 2014''.
SEC. 2. SCHEDULING OF SUBSTANCES INCLUDED IN NEW FDA-APPROVED DRUGS.
Section 201 of the Controlled Substances Act (21 U.S.C. 811) is
amended by inserting after subsection (h) the following:
``(i) Within 45 days of receiving a recommendation from the
Secretary to add a drug or substance that has never been marketed in
the United States to a schedule under this title, the Attorney General
shall, without regard to the findings required by subsection (a) of
this section or section 202(b), issue an interim final rule, under the
exception for good cause described in subparagraph (B) of section
553(b) of title 5, United States Code, placing the drug or substance
into the schedule recommended by the Secretary. The interim final rule
shall be made immediately effective under section 553(d)(3) of title 5,
United States Code.''.
SEC. 3. ENHANCING NEW DRUG DEVELOPMENT.
Section 302 of the Controlled Substances Act (21 U.S.C. 822) is
amended by inserting after subsection (g) the following:
``(h)(1) A person who submits an application for registration to
manufacture or distribute a controlled substance in accordance with
this section may indicate on the registration application that the
substance will be used only in connection with clinical trials of a
drug in accordance with section 505(i) of the Federal Food, Drug, and
Cosmetic Act.
``(2) When an application for registration to manufacture or
distribute a controlled substance includes an indication that the
controlled substance will be used only in connection with clinical
trials of a drug in accordance with section 505(i) of the Federal Food,
Drug, and Cosmetic Act, the Attorney General shall--
``(A) make a final decision on the application for
registration within 180 days; or
``(B) provide notice to the applicant in writing of--
``(i) the outstanding issues that must be resolved
in order to reach a final decision on the application;
and
``(ii) the estimated date on which a final decision
on the application will be made.''.
SEC. 4. 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 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, or has reason to
believe that--
``(A) the dispensing is outside the usual course of
professional practice;
``(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
``(C) the controlled substances will continue to be
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;
(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. 5. REPORT TO CONGRESS ON EFFECTS OF LAW ENFORCEMENT ACTIVITIES ON
PATIENT ACCESS TO MEDICATIONS.
(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, 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.
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