Ensuring Patient Access and Effective Drug Enforcement Act of 2014

Summary: Ensuring Patient Access and Effective Drug Enforcement Act of 2014 - Amends the Controlled Substances Act to define: (1) "factors as may be relevant to and consistent with the public health and safety," for purposes of the Attorney General's determination of whether registering an applicant to manufacture or distribute a controlled substance in schedule I or II is in the public interest, as factors that are relevant to and consistent with the findings of such Act; and (2) "imminent danger to the public health or safety," for purposes of the suspension of such a registration, to mean that in the absence of an immediate suspension order, controlled substances will continue to be intentionally diverted outside of legitimate distribution channels or distributed or dispensed outside the usual course of professional practices or in a manner that poses a present or foreseeable risk of serious adverse health consequences or death. Requires an order to show cause as to why such a registration should not be denied, revoked, or suspended to: (1) contain a statement of the basis for the denial, revocation, or suspension, including specific citations to any laws or regulations alleged to be violated; (2) direct the applicant or registrant to appear before the Attorney General at a specific place and time within 30 days after receipt of the order; and (3) notify the applicant or registrant of the opportunity to submit a corrective action plan on or before such appearance. 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 modifications to such plan. Makes such requirements inapplicable to the issuance of an immediate suspension order. Directs the Secretary of Health and Human Services (HHS), acting through the Commissioner of Food and Drugs (FDA) and the Director of the Centers for Disease Control and Prevention (CDC), to submit a report 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.

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.