Ensuring Patient Access and Effective Drug Enforcement Act of 2014

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.

[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4709 Introduced in House (IH)]

113th CONGRESS
  2d Session
                                H. R. 4709

 To improve enforcement efforts related to prescription drug diversion 
                   and abuse, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 21, 2014

   Mr. Marino (for himself, Mrs. Blackburn, Mr. Welch, and Ms. Chu) 
 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 2014''.

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) 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. 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 
Congress--
            (1) assessing how patient access to medications could be 
        adversely impacted by Federal and State law enforcement 
        activities; and
            (2) identifying how collaboration between agencies and 
        stakeholders 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) Manufacturers of drugs.
            (4) Common or contract carriers and warehousemen.
            (5) Hospitals, physicians, and other health care providers.
            (6) State attorneys general.
            (7) Law enforcement officials, including local law 
        enforcement officials.
            (8) Health benefit plans and entities that provide pharmacy 
        benefit management services on behalf of a health benefit plan.
            (9) Wholesale drug distributors.
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