H. Rept. 113-605 - ENSURING PATIENT ACCESS AND EFFECTIVE DRUG ENFORCEMENT ACT OF 2014113th Congress (2013-2014)
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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 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\ --------------------------------------------------------------------------- \1\http://www.cdc.gov/homeandrecreationalsafety/rxbrief/. --------------------------------------------------------------------------- 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. --------------------------------------------------------------------------- \2\H.R. 4709 is a reintroduced version of H.R. 4069, the ``Ensuring Patient Access and Effective Drug Enforcement of 2013.'' --------------------------------------------------------------------------- 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. 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: 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. 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 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): 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) * * * * * * * * * * [(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. [(d) The Attorney General] (d)(1) The Attorney General may, in his discretion, suspend any registration simultaneously with the institution 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. * * * * * * *