Ensuring Patient Access and Effective Drug Enforcement Act of 2015

Bill: 114-hr-471
Sponsor: full_name: Rep. Marino, Tom [R-PA-10]
Introduced: 2015-01-22
Policy area: Crime and Law Enforcement
Subjects: Administrative remedies

Congressional oversight

Department of Justice

Drug trafficking and controlled substances

Government information and archives

Government studies and investigations

Health care coverage and access

Licensing and registrations

Prescription drugs

Retail and wholesale trades
Latest action: action_date: 2015-04-22
text: Received in the Senate and Read twice and referred to the Committee on the Judiciary.

Summaries:
action_date: 2015-01-22
action_desc: Introduced in House
text: <p><b>Ensuring Patient Access and Effective Drug Enforcement Act of 2015</b></p> <p> 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.</p> <p>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.</p> <p>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.</p>

action_date: 2015-04-20
action_desc: Reported to House without amendment, Part I
text: <p>(This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.)</p> <p><b>Ensuring Patient Access and Effective Drug Enforcement Act of 2015</b></p> <p> (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.</p> <p>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.</p> <p>(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.</p>

action_date: 2015-04-21
action_desc: Passed House amended
text: <p><b>Ensuring Patient Access and Effective Drug Enforcement Act of 2015</b></p> <p> (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.</p> <p>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.</p> <p>(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.</p>

tv_txt: I 114th CONGRESS 1st Session H. R. 471 IN THE HOUSE OF REPRESENTATIVES January 22, 2015 Mr. Marino (for himself, Mr. Welch , Mrs. Blackburn , and Ms. Chu of California ) 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.

1. Short title This Act may be cited as the Ensuring Patient Access and Effective Drug Enforcement Act of 2015 . 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). . 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 Committee 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.

tv_txt: IB Union Calendar No. 63 114th CONGRESS 1st Session H. R. 471 [Report No. 114–85, Part I] IN THE HOUSE OF REPRESENTATIVES January 22, 2015 Mr. Marino (for himself, Mr. Welch , Mrs. Blackburn , and Ms. Chu of California ) 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 April 20, 2015 Additional sponsors: Mr. Collins of Georgia , Mr. Bilirakis , and Mr. Costello of Pennsylvania April 20, 2015 Reported from the Committee on Energy and Commerce April 20, 2015 The Committee on the Judiciary discharged; committed to the Committee of the Whole House on the State of the Union and ordered to be printed A BILL To improve enforcement efforts related to prescription drug diversion and abuse, and for other purposes.

1. Short title This Act may be cited as the Ensuring Patient Access and Effective Drug Enforcement Act of 2015 . 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). . 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 Committee 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.

April 20, 2015 Reported from the Committee on Energy and Commerce April 20, 2015 The Committee on the Judiciary discharged; committed to the Committee of the Whole House on the State of the Union and ordered to be printed

tv_txt: IIB 114th CONGRESS 1st Session H. R. 471 IN THE SENATE OF THE UNITED STATES April 22, 2015 Received; read twice and referred to the Committee on the Judiciary AN ACT To improve enforcement efforts related to prescription drug diversion and abuse, and for other purposes.

1. Short title This Act may be cited as the Ensuring Patient Access and Effective Drug Enforcement Act of 2015 . 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 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— (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). . 3. 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, in coordination with the Administrator of the Drug Enforcement Administration and in consultation with the Secretary of Defense and the Secretary of Veterans Affairs, shall submit a report to the Committee 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. (10) Veterinarians.

Passed the House of Representatives April 21, 2015. Karen L. Haas, Clerk

tv_txt: I 114th CONGRESS 1st Session H. R. 471 IN THE HOUSE OF REPRESENTATIVES AN ACT To improve enforcement efforts related to prescription drug diversion and abuse, and for other purposes.

1. Short title This Act may be cited as the Ensuring Patient Access and Effective Drug Enforcement Act of 2015 . 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 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— (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). . 3. 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, in coordination with the Administrator of the Drug Enforcement Administration and in consultation with the Secretary of Defense and the Secretary of Veterans Affairs, shall submit a report to the Committee 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. (10) Veterinarians.

Passed the House of Representatives April 21, 2015. Karen L. Haas, Clerk.