Ensuring Patient Access and Effective Drug Enforcement Act of 2014

Bill: 113-hr-4709
Sponsor: full_name: Rep. Marino, Tom [R-PA-10]
Introduced: 2014-05-21
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: 2014-07-30
text: Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Summaries:
action_date: 2014-05-21
action_desc: Introduced in House
text: <p>Ensuring Patient Access and Effective Drug Enforcement Act of 2014 - Amends the Controlled Substances Act to provide that: (1) a determination by the Attorney General that a registration to manufacture, distribute, or dispense a controlled substance is "consistent with the public health and safety" means that it has a substantial relationship to such Act's purpose of preventing diversion and abuse of controlled substances; and (2) a finding of "imminent danger" by the Attorney General justifying immediate suspension of such a registration means that there is a significant and present risk of death or serious bodily harm that is more likely than not to occur in the absence of such a suspension.</p> <p>Requires the Attorney General, before revoking or suspending a registration under such Act, to: (1) provide the registrant notice of the grounds for doing so, and where such grounds consist of a legal violation, a specific citation to such law; (2) give the registrant an opportunity to submit a corrective action plan within a reasonable time period; and (3) determine whether, in light of the plan, revocation or suspension proceedings should be discontinued or deferred or additional changes need to be made in such plan.</p> <p>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: (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. </p>

action_date: 2014-07-29
action_desc: Passed House amended
text: <p>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.</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 (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.</p>

tv_txt: I 113th CONGRESS 2d Session H. R. 4709 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.

1. Short title This Act may be cited as the Ensuring Patient Access and Effective Drug Enforcement Act of 2014 . 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. . 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.

tv_txt: I 113th CONGRESS 2d Session H. R. 4709 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 2014 . 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 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. Karen L. Haas, Clerk.

tv_txt: IIB 113th CONGRESS 2d Session H. R. 4709 IN THE SENATE OF THE UNITED STATES July 30, 2014 Received; read twice and referred to the Committee on Health, Education, Labor, and Pensions 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 2014 . 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 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. Karen L. Haas, Clerk