Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act of 2014

Summary: Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act of 2014 - Amends the Controlled Substances Act to direct the Attorney General, within 45 days of receiving a recommendation from the Secretary of Health and Human Services (HHS) to add a drug or substance that has never been marketed in the United States to a schedule of controlled substances, to issue an interim final rule under the exception for good cause, placing it into the schedule recommended, effective immediately. Allows a person who submits an application for registration to manufacture or distribute a controlled substance to indicate on the registration application that the substance will be used only in connection with clinical trials of a drug. Requires the Attorney General to: (1) make a final decision on such application within 180 days, or (2) provide written notice to the applicant of the outstanding issues that must be resolved to reach a final decision and the estimated date on which such decision will be made. Defines: (1) "factors as may be relevant to and consistent with the public health and safety," and (2) "imminent danger to the public health or safety." Requires an order to show cause as to why a registration should not be denied, revoked, or suspended to notify the registrant of the opportunity to submit a corrective action plan on or before the date of appearance before the Attorney General. Requires the Attorney General, upon review of any such plan, to determine whether denial, revocation, or suspension proceedings should be discontinued or deferred for purposes of modification or clarification of such plan. Makes these requirements inapplicable to the issuance of an immediate suspension order. Directs the Secretary, acting through the Commissioner of Food and Drugs (FDA) and the Director of the Centers for Disease Control and Prevention (CDC), to identify: (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.

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.