39–006 

113TH CONGRESS REPT. 113–605 " ! HOUSE OF REPRESENTATIVES 2d Session Part 1 

ENSURING PATIENT ACCESS AND EFFECTIVE DRUG 

ENFORCEMENT ACT OF 2014 

JULY 29, 2014.—Ordered to be printed 

Mr. UPTON, from the Committee on Energy and Commerce, 

submitted the following 

R E P O R T 

[To accompany H.R. 4709] 

[Including cost estimate of the Congressional Budget Office] 

The Committee on Energy and Commerce, to whom was referred 

the bill (H.R. 4709) to improve enforcement efforts related to prescription drug diversion and abuse, and for other purposes, having 

considered the same, report favorably thereon without amendment 

and recommend that the bill do pass. 

CONTENTS 

Page 

Purpose and Summary ............................................................................................ 1 

Background and Need for Legislation .................................................................... 2 

Hearings ................................................................................................................... 2 

Committee Consideration ........................................................................................ 2 

Committee Votes ...................................................................................................... 3 

Committee Oversight Findings ............................................................................... 3 

Statement of General Performance Goals and Objectives .................................... 3 

New Budget Authority, Entitlement Authority, and Tax Expenditures ............. 3 

Earmark, Limited Tax Benefits, and Limited Tariff Benefits ............................. 3 

Committee Cost Estimate ....................................................................................... 3 

Congressional Budget Office Estimate ................................................................... 3 

Federal Mandates Statement ................................................................................. 4 

Duplication of Federal Programs ............................................................................ 4 

Disclosure of Directed Rule Makings ..................................................................... 5 

Advisory Committee Statement .............................................................................. 5 

Applicability to Legislative Branch ........................................................................ 5 

Section-by-Section Analysis of the Legislation ...................................................... 5 

Changes in Existing Law Made by the Bill, as Reported ..................................... 6 

PURPOSE AND SUMMARY

H.R. 4709 would help prevent prescription drug abuse while ensuring that patients have access to needed medications by fostering 


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1http://www.cdc.gov/homeandrecreationalsafety/rxbrief/. 

2 H.R. 4709 is a reintroduced version of H.R. 4069, the ‘‘Ensuring Patient Access and Effective 

Drug Enforcement of 2013.’’ 

better collaboration between drug manufacturers, wholesalers, 

pharmacies, Drug Enforcement Administration (DEA), and the 

Food and Drug Administration (FDA). 

BACKGROUND AND NEED FOR LEGISLATION

Millions of Americans rely on prescription drugs to treat and 

cure illnesses, alleviate pain, and prolong and improve the quality 

of their lives. Unfortunately, prescription drug abuse kills tens of 

thousands of Americans each year, requiring constant vigilance 

throughout the prescription drug supply chain to halt and prevent 

drug abuse and diversion.1

The supply chain involves many stakeholders, including drug 

manufacturers, wholesale distributors, doctors, nurses, pharmacists, hospitals, and retail pharmacies. Protecting the system 

from criminal exploitation and ensuring its efficiency requires significant investment from both the government’s enforcement and 

oversight agencies and the system’s private operators. Law enforcement must have the tools to act decisively and quickly. Private industry must have the assurance that lawful conduct will ensure 

due process, protect them from secondary liability, and shield them 

from disabling disruptions—disruptions that endanger the health 

and safety of individual patients. The integrity of the system depends on clear rules for enforcement agencies and for providers. 

The Ensuring Patient Access and Effective Drug Enforcement 

Act of 2014 would clarify these rules by providing certainty with 

how federal authorities will apply the law when undertaking enforcement actions, and by increasing the investment that private 

industry must make to ensure the integrity of the system. 

HEARINGS

The Subcommittee on Health held a hearing on H.R. 4069 on 

April 7, 2014.2 The Subcommittee received testimony from: Janet 

Woodcock, M.D., Director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; Joseph T. Rannazzisi, 

Deputy Assistant Administrator, Office of Diversion Control, Drug 

Enforcement Administration; Nathan B. Fountain, Chair, Medical 

Advisory Board, Epilepsy Foundation; John M. Gray, President and 

CEO, Healthcare Distribution Management Association; Linden 

Barber, Partner and Director, DEA Compliance Operations, 

Quarles & Brady; and Wendy K.D. Selig, President and CEO, 

Melanoma Research Alliance. 

COMMITTEE CONSIDERATION

On May 28, 2014, the Subcommittee on Health met in open 

markup session and approved H.R. 4709 for full Committee consideration by a voice vote. On June 10, 2014, the full Committee 

adopted a technical amendment by a voice vote and approved the 

bill, as amended, by a voice vote. 


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COMMITTEE VOTES

Clause 3(b) of rule XIII of the Rules of the House of Representatives requires the Committee to list the record votes on the motion 

to report legislation and amendments thereto. There were no 

record votes taken in connection with ordering H.R. 4709 reported. 

A motion by Mr. Upton to order H.R. 4709 reported to the House, 

with amendment, was agreed to by a voice vote. 

COMMITTEE OVERSIGHT FINDINGS

Pursuant to clause 3(c)(1) of rule XIII of the Rules of the House 

of Representatives, the Committee held a hearing and made findings that are reflected in this report. 

STATEMENT OF GENERAL PERFORMANCE GOALS AND OBJECTIVES

The purpose of this act is to address the nation’s prescription 

drug abuse crisis by improving the working relationship among private industry, government agencies, providers, and patient advocates. 

NEW BUDGET AUTHORITY, ENTITLEMENT AUTHORITY, AND TAX

EXPENDITURES

In compliance with clause 3(c)(2) of rule XIII of the Rules of the 

House of Representatives, the Committee finds that H.R. 4709, Ensuring Patient Access and Effective Drug Enforcement Act of 2014, 

would result in no new or increased budget authority, entitlement 

authority, or tax expenditures or revenues. 

EARMARK, LIMITED TAX BENEFITS, AND LIMITED TARIFF BENEFITS

In compliance with clause 9(e), 9(f), and 9(g) of rule XXI of the 

Rules of the House of Representatives, the Committee finds that 

H.R. 4709, Ensuring Patient Access and Effective Drug Enforcement Act of 2014, contains no earmarks, limited tax benefits, or 

limited tariff benefits. 

COMMITTEE COST ESTIMATE

The Committee adopts as its own the cost estimate prepared by 

the Director of the Congressional Budget Office pursuant to section 

402 of the Congressional Budget Act of 1974. 

CONGRESSIONAL BUDGET OFFICE ESTIMATE

Pursuant to clause 3(c)(3) of rule XIII of the Rules of the House 

of Representatives, the following is the cost estimate provided by 

the Congressional Budget Office pursuant to section 402 of the 

Congressional Budget Act of 1974: 


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U.S. CONGRESS, CONGRESSIONAL BUDGET OFFICE, Washington, DC, July 7, 2014. 

Hon. FRED UPTON, 

Chairman, Committee on Energy and Commerce, 

House of Representatives, Washington, DC. 

DEAR MR. CHAIRMAN: The Congressional Budget Office has prepared the enclosed cost estimate for H.R. 4709, the Ensuring Patient Access and Effective Drug Enforcement Act of 2014. 

If you wish further details on this estimate, we will be pleased 

to provide them. The CBO staff contact is Mark Grabowicz. 

Sincerely, 

PETER H. FONTAINE

(For Douglas W. Elmendorf). 

Enclosure. 

H.R. 4709—Ensuring Patient Access and Effective Drug Enforcement Act of 2014 

H.R. 4709 would modify certain administrative procedures followed by the Department of Justice in regulating controlled substances. In addition, within one year of enactment, the bill would 

require the Department of Health and Human Services to assess 

the effect of law enforcement activities on access to medications, examine potential benefits to patients from collaborations between 

governments and stakeholders, and report to the Congress on these 

matters. 

Based on the cost of similar activities, CBO estimates that implementing the bill would cost less than $500,000 in 2015; any spending would be subject to availability of appropriated funds. Enacting 

the legislation would not affect direct spending or revenues; therefore, pay-as-you-go procedures do not apply. 

H.R. 4709 contains no intergovernmental or private-sector mandates as defined in the Unfunded Mandates Reform Act and would 

impose no costs on state, local, or tribal governments. 

The CBO staff contacts for this estimate are Mark Grabowicz 

and Jean Hearne. The estimate was approved by Theresa Gullo, 

Deputy Assistant Director for Budget Analysis. 

FEDERAL MANDATES STATEMENT

The Committee adopts as its own the estimate of Federal mandates prepared by the Director of the Congressional Budget Office 

pursuant to section 423 of the Unfunded Mandates Reform Act. 

DUPLICATION OF FEDERAL PROGRAMS

No provision of H.R. 4709, Ensuring Patient Access and Effective 

Drug Enforcement Act of 2014 establishes or reauthorizes a program of the Federal Government known to be duplicative of another Federal program, a program that was included in any report 

from the Government Accountability Office to Congress pursuant to 

section 21 of Public Law 111–139, or a program related to a program identified in the most recent Catalog of Federal Domestic Assistance. 


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DISCLOSURE OF DIRECTED RULE MAKINGS

The Committee estimates that enacting H.R. 4709, Ensuring Patient Access and Effective Drug Enforcement Act of 2014 does not 

direct any specific rule making within the meaning of 5 U.S.C. 551. 

ADVISORY COMMITTEE STATEMENT

No advisory committees within the meaning of section 5(b) of the 

Federal Advisory Committee Act were created by this legislation. 

APPLICABILITY TO LEGISLATIVE BRANCH

The Committee finds that the legislation does not relate to the 

terms and conditions of employment or access to public services or 

accommodations within the meaning of section 102(b)(3) of the Congressional Accountability Act. 

SECTION-BY-SECTION ANALYSIS OF THE LEGISLATION

Section 1, Short title 

Section provides the short title of ‘‘Ensuring Patient Access and 

Effective Drug Enforcement Act of 2013.’’ 

Section 2, Registration process under Controlled Substances Act 

Section 2 of the bill clarifies two definitions within the Controlled 

Substances Act (CSA) essential to providing a clear path forward 

for the enforcement agencies and lawful purveyors of controlled 

substances. These two clarifications establish clear standards for 

the DEA that will facilitate consistent enforcement of the CSA, 

while also protecting the due process rights of lawful providers of 

controlled substances, preventing overly broad and unsubstantiated 

enforcement orders. The technical clarifications will promote certainty in the regulatory and enforcement regime, focusing law enforcement’s resources and protecting patients from unintended disruptions in the supply chain. 

First, the bill specifies that the phrase ‘‘consistent with the public health and safety’’ corresponds to a ‘‘substantial relationship to 

. . . preventing diversion and abuse of controlled substances.’’ The 

vague phrase ‘‘consistent with the public health and safety’’ requires explanation because it has created inconsistent enforcement 

actions and has left the courts of review with uncertainty about 

Congress’ intent. This specification will ensure that law enforcement can effectively investigate and target dangerous offenders 

without wasting resources on unconnected parties in the supply 

chain. 

The U.S. Code lacks a definition for the phrase ‘‘consistent with 

public health and safety.’’ Its closest corollary, ‘‘consistent with the 

public interest,’’ has been the subject of numerous court decisions 

and regulatory proceedings within antitrust and administrative 

law, for example. Unlike the ‘‘public interest,’’ the Executive 

Branch has never promulgated regulations or issued legal guidance 

concerning the CSA’s ‘‘consistent with public health and safety.’’ 

Congress enacted the CSA to halt and prevent the diversion and 

abuse of controlled substances, and this bill explicitly reaffirms the 

central purpose of the Act with this specification. The term ‘‘consistent with the public health and safety’’ will now be defined as 


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having a substantial relationship to the Act’s purpose of preventing 

diversion and abuse of controlled substances. 

Second, the bill further defines ‘‘imminent danger’’ to indicate 

those circumstances that pose 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.’’ The vagueness 

of the term ‘‘imminent danger’’ has created uneven enforcement applications, and this clarification will ensure that action will take 

place only in the presence of direct and urgent danger. 

This clarification harmonizes the CSA with other statutes using 

the ‘‘imminent danger’’ standard, namely the Federal Mine Safety 

and Health Act (‘‘Mine Act’’) and Occupational Safety and Health 

Act (‘‘OSHA’’). Both the Mine Act and OSHA authorize federal authorities to take expedited action when serious, current, and persistent threats persist. The circumstances must be grave and immediate because such federal action denies the subjects of the enforcement their ability to function; severe deprivations of liberty require severe danger. 

To ensure transparency and due process, section 2 requires that 

when the Attorney General suspends or revokes a party’s registration—the registration that enables the party to operate lawfully 

within the controlled substance market—that the Attorney General 

must provide notice to the party, cite with specificity any laws that 

may have been contravened, and give the party the opportunity to 

submit a corrective action plan in order to remedy any potential 

violations. The Attorney General must weigh the registrant’s corrective action plan and suggest additional changes as any revocation or suspension actions proceed. 

Preventing diversion and drug abuse depends on consistent application of the CSA, and this provision ensures that law enforcement and private registrants will collaborate to achieve these aims. 

Section 3, Report to Congress on effects of law enforcement activities 

on patient access to medications 

Finally, section 3 requires the Secretary of HHS to work with the 

Commissioner of the FDA, Director of the Center for Disease Control and Prevention (CDC), Administrator of the DEA, and Director 

of the Director of National Drug Control Policy (ONDCP) to submit 

a report to Congress within one year of enactment. The report will 

assess how patient access to medication could be adversely affected 

by Federal and State law enforcement activities and identify how 

collaboration between agencies and stakeholders can benefit patients and prevent diversion and abuse of controlled substances. 

This report also will incorporate feedback and recommendations 

from the various stakeholders. 

CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED

In compliance with clause 3(e) of rule XIII of the Rules of the 

House of Representatives, changes in existing law made by the bill, 

as reported, are shown as follows (existing law proposed to be omitted is enclosed in black brackets, new matter is printed in italic, 

existing law in which no change is proposed is shown in roman): 


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CONTROLLED SUBSTANCES ACT 

* * * * * * * 

TITLE II—CONTROL AND ENFORCEMENT 

* * * * * * * 

PART C—REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND

DISPENSERS OF CONTROLLED SUBSTANCES; PIPERIDINE REPORTING

* * * * * * * 

REGISTRATION REQUIREMENTS

SEC. 303. (a) * * * 

* * * * * * * 

(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. 

DENIAL, REVOCATION, OR SUSPENSION OF REGISTRATION

SEC. 304. (a) * * * 

* * * * * * * 

ø(c) Before¿ (c)(1) Before taking action pursuant to this section, 

or pursuant to a denial of registration under section 303, the Attorney General shall serve upon the applicant or registrant an order 

to show cause why registration should not be denied, revoked, or 

suspended. The order to show cause shall contain a statement of 

the basis thereof and shall call upon the applicant or registrant to 

appear before the Attorney General at a time and place stated in 

the order, but in no event less than thirty days after the date of 

receipt of the order. Proceedings to deny, revoke, or suspend shall 

be conducted pursuant to this section in accordance with subchapter II of chapter 5 of title 5 of the United States Code. Such 

proceedings shall be independent of, and not in lieu of, criminal 

prosecution or other proceedings under this title or any other law 

of the United States. 

(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. 

ø(d) The Attorney General¿ (d)(1) The Attorney General may, in 

his discretion, suspend any registration simultaneously with the inVerDate Sep 11 2014 01:41 Sep 23, 2014 Jkt 039006 PO 00000 Frm 00007 Fmt 6659 Sfmt 6601 E:\HR\OC\HR605P1.XXX HR605P1

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stitution of proceedings under this section, in cases where he finds 

that there is an imminent danger to the public health or safety. A 

failure to comply with a standard referred to in section 303(g)(1) 

may be treated under this subsection as grounds for immediate 

suspension of a registration granted under such section. A suspension under this subsection shall continue in effect until the conclusion of such proceedings, including judicial review thereof, unless 

sooner withdrawn by the Attorney General or dissolved by a court 

of competent jurisdiction. 

(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. 

* * * * * * * 

Æ 


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