H. R. 483 – Ensuring Patient Access and Effective Drug Enforcement Act of 2016
114th Congress (2015-2016)

Sponsor: Sen. Hatch, Orrin G [R-UT]
Introduced 2/12/15
Committees: Senate – Judiciary
Latest Action:   04/19/2016 Became  Public Law No: 114-145

Cosponsor                               Date Cosponsored

Sen. Whitehouse, Sheldon [D-RI]     2/12/2015
Sen. Rubio, Marco [R-FL]           3/17/2015
Sen. Vitter, David [R-LA]            3/23/2015
Sen. Cassidy, Bill [R-LA]            4/22/2015

Date                Actions Overview
4/19/2016        Became Public Law No: 114-145
4/19/2016        Signed by President
4/14/2016        Presented to President
4/12/2016        Passed/agreed to in House: On passage Passed without objection
3/17/2016        Passed/agreed to in Senate: Passed Senate with an amendment by unanimous consent
2/11/2016        Committee on the Judiciary
2/12/2015        Introduced in Senate

Summary:

(Sec. 2) This bill amends the Controlled Substances Act to define phrases related to the Drug Enforcement Administration’s (DEA’s) authority to register manufacturers, distributors, and dispensers of controlled substances.

Currently, the DEA registers a controlled substances manufacturer, distributor, or dispenser if it is in the public interest after considering certain factors, including factors relevant to and consistent with the public health and safety. This bill defines “factors as may be relevant to and consistent with the public health and safety” to mean factors relevant to and consistent with the specified purposes of the Controlled Substances Act.

Additionally, current law allows the DEA to immediately suspend a registration to prevent imminent danger to the public health and safety. This bill defines “imminent danger to the public health and safety” to mean an immediate threat of death, serious bodily harm, or abuse of a controlled substance due to a registrant’s failure to maintain effective controls against diversion.

The bill revises and expands the required elements of an order to show cause issued by the DEA before it denies, revokes, or suspends a registration for a Controlled Substances Act violation. An order to show cause must specifically state the legal basis for the action and notify the registrant of the opportunity to submit a corrective action plan.

(Sec. 3) The Food and Drug Administration, the Substance Abuse and Mental Health Services Administration, the Agency for Research and Quality, and the Centers for Disease Control and Prevention, in coordination with the DEA, must report to Congress on:

1. obstacles to legitimate patient access to controlled substances;
2. diversion of controlled substances;
3. how collaboration between law enforcement agencies and the pharmaceutical industry can benefit patients and prevent diversion and abuse of controlled substances;
4. the availability of and gaps in medical education, training opportunities, and comprehensive clinical guidance for pain management and opioid prescribing;
5. enhancements to prescription drug monitoring programs; and
6. improvements to prescription opioid reporting requirements.

Public Law No: 114-145 (04/19/2016)

ENSURING PATIENT ACCESS AND EFFECTIVE DRUG ENFORCEMENT ACT OF 201

An Act

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 2016”.

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:

“(j) 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 (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, due to the failure of the registrant to maintain effective controls against diversion or otherwise comply with the obligations of a registrant under this title or title III, there is a substantial likelihood of an immediate threat that death, serious bodily harm, or abuse of a controlled substance will occur in the absence of an immediate suspension of the registration.”. 101.”.

(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 three 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).”.

SEC. 3. REPORT TO CONGRESS.

(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, the Administrator of the Substance Abuse and Mental Health Services Administration, the Director of the Agency for Healthcare Research and Quality, 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;

(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;

(4) the availability of medical education, training opportunities, and comprehensive clinical guidance for pain management and opioid prescribing, and any gaps that should be addressed;

(5) beneficial enhancements to State prescription drug monitoring programs, including enhancements to require comprehensive prescriber input and to expand access to the

programs for appropriate authorized users; and

(6) steps to improve reporting requirements so that the public and Congress have more information regarding prescription opioids, such as the volume and formulation of prescription opioids prescribed annually, the dispensing of such prescription opioids, and outliers and trends within large data sets.

(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. (11) Professional medical societies and boards. (12) State and local public health authorities. (13) Health services research organizations.