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

H.R. 4709

Ensuring Patient Access and Effective Drug Enforcement Act of 2014

Sponsor
Rep. Tom Marino

Date
July 29, 2014 (113th Congress, 2nd Session)

Staff Contact
Communications

Floor Situation

On Tuesday, July 29, 2014, the House will consider H.R. 4709, the Ensuring Patient Access and Effective Drug Enforcement Act of 2014, under a suspension of the rules.  H.R. 4709 was introduced on May 21, 2014 by Rep. Tom Marino (R-PA) and referred to the Committee on Energy and Commerce, which ordered the bill reported, as amended, by voice vote.

Bill Summary

H.R. 4709 establishes clear standards for federal agencies and private parties within the prescription drug supply chain, in order to facilitate consistent enforcement of the Controlled Substances Act (CSA) and ensure that legitimate patient access to medication is not unnecessarily interrupted.    The Act adds clarifying definitions to several terms used in the CSA and, absent there being an imminent danger to the public health and safety, provides supply chain stakeholders registered with the Drug Enforcement Administration (DEA) an opportunity to submit a corrective action plan prior to revocation or suspension.  This allows companies to adhere to compliance standards while protecting patients from potentially dangerous disruptions in the supply chain.

Within one year of enactment, the Secretary of Health and Human Services (HHS) would be required to submit a report to Congress 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.  The report is required to incorporate feedback and recommendations from patient groups; pharmacies; drug manufacturers; contract carriers and warehousemen; hospitals and physicians; State attorneys general; law enforcement agencies; health insurance providers; and drug distributors.

Background

The Controlled Substances Act (CSA) is “the statuary framework through which the federal government regulates the lawful production, possession, and distribution of controlled substances.”[1]  Between 10 and 11 percent of all drug prescriptions written in the U.S. are for controlled substances.[2]  According to recent estimates, approximately 6.8 million individuals abuse prescription drugs.[3]  Nearly 15,000 overdose deaths are linked to prescription pain relievers, more than heroin and cocaine combined.[4]  Along with the CSA, the Federal Food, Drug, and Cosmetic Act (FFDCA) is the other primary federal statute governing the regulation of prescription drugs.[5]  The FFDCA gives the FDA responsibility for “ensuring the safety and effectiveness of prescription and nonprescription drugs sold in the United States.”[6]  However, despite these statutory frameworks, the prescription drug abuse epidemic continues.  H.R. 4709 attempts to set clear standards for the federal government, law enforcement agencies, and private parties within the prescription drug supply chain; provides the industry with an opportunity to submit a corrective action plan to address potential violations in the absence of an imminent danger to public health and safety; and attempts to identify potential areas of cooperation between law enforcement and the industry that can prevent further abuse.

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[1] Brian T. Yeh, “The Controlled Substances Act: Regulatory Requirements,” Congressional Research Service (Dec. 13, 2012), at 1.
[2] See Id. at “Summary”
[3] Erin Bagalman, Lisa N. Sacco, Susan Thaul, and Brian T. Yeh, “Prescription Drug Abuse,” Congressional Research Service (May 21, 2014), at 1.
[4] Erin Bagalman, “Prescription Drug Abuse,” CRS, at 1.
[5] Id. at 3.
[6] Id. at 3.

Cost

CBO estimates that enacting H.R .4709 would cost less than $500,000 in 2015, subject to the availability of appropriated funds.[7]  Enacting this legislation would not affect direct spending or revenues.

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[7] http://www.cbo.gov/sites/default/files/cbofiles/attachments/hr4709.pdf

Additional Information

For questions or further information contact the GOP Conference at 5-5107.