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H.R. 471

Ensuring Patient Access and Effective Drug Enforcement Act of 2015

Ensuring Patient Access and Effective Drug Enforcement Act of 2015

(Sec. 2) 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 distributed or dispensed by a registrant who knows or should know through fulfilling the obligations of the registrant under this Act that the dispensing is outside the usual course of professional practice, 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 the controlled substances will continue to be diverted outside of legitimate distribution channels.

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.

(Sec. 3) Directs 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, 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.

Received in the Senate and Read twice and referred to the Committee on the Judiciary.

Rep. Marino, Tom [R-PA-10](R-PA)Sponsor
6 cosponsors2 D4 R
6cosponsors3committees19actions1related bills10subjects
  1. IntroReferral

    Received in the Senate and Read twice and referred to the Committee on the Judiciary.

    Judiciary Committee
  2. FloorH38310

    Motion to reconsider laid on the table Agreed to without objection.

  3. FloorH37300

    On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H2329)

  4. Floor8000

    Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.(text: CR H2329)

  5. FloorH8D000

    DEBATE - The House proceeded with forty minutes of debate on H.R. 471.

  6. FloorH30000

    Considered under suspension of the rules. (consideration: CR H2329-2332)

  7. FloorH30300

    Mrs. Blackburn moved to suspend the rules and pass the bill, as amended.

  8. CalendarsH12410

    Placed on the Union Calendar, Calendar No. 63.

  9. DischargeH12300

    Committee on the Judiciary discharged.

    Judiciary Committee
  10. Committee5500

    Committee on the Judiciary discharged.

    Judiciary Committee
  11. CommitteeH12200

    Reported by the Committee on Energy and Commerce. H. Rept. 114-85, Part I.

    Energy and Commerce Committee
  12. Committee5000

    Reported by the Committee on Energy and Commerce. H. Rept. 114-85, Part I.

    Energy and Commerce Committee
  13. Committee

    Referred to the Subcommittee on Crime, Terrorism, Homeland Security, and Investigations.

    Crime and Federal Government Surveillance Subcommittee
  14. Committee

    Referred to the Subcommittee on Health.

    Health Subcommittee
  15. IntroReferralH11100

    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.

    Judiciary Committee
  16. IntroReferralH11100-A

    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.

  17. IntroReferralH11100

    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.

    Energy and Commerce Committee
  18. IntroReferralIntro-H

    Introduced in House

  19. IntroReferral1000

    Introduced in House

Apr 21, 201536

Ensuring Patient Access and Effective Drug Enforcement Act of 2015

(Sec. 2) 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 distributed or dispensed by a registrant who knows or should know through fulfilling the obligations of the registrant under this Act that the dispensing is outside the usual course of professional practice, 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 the controlled substances will continue to be diverted outside of legitimate distribution channels.

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.

(Sec. 3) Directs 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, 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.

Apr 20, 201528

(This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.)

Ensuring Patient Access and Effective Drug Enforcement Act of 2015

(Sec. 2) 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.

(Sec. 3) Directs 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, 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.

Jan 22, 2015

Ensuring Patient Access and Effective Drug Enforcement Act of 2015

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, acting through the Commissioner of Food and Drugs and the Director of the Centers for Disease Control and Prevention, 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.

Ensuring Patient Access and Effective Drug Enforcement Act of 2015 — Informed