H.R. 4976, Opioid Review Modernization Act

H.R. 4976

Opioid Review Modernization Act

Sponsor
Rep. Sean Patrick Maloney

Date
May 11, 2016 (114th Congress, 2nd Session)

Staff Contact
Robert Goad

Floor Situation

On Wednesday, May 11, 2016, the House will consider H.R. 4976, the Opioid Review Modernization Act, under suspension of the rules. H.R. 4976 was introduced on April 18, 2016 by Rep. Sean Patrick Maloney (D-NY), and was referred to the Committee on Energy and Commerce, which ordered the bill reported, by voice vote, on April 27, 2016.

Bill Summary

H.R. 4976 seeks to cut down on opioid abuse by improving education for prescribing physicians and encouraging the pharmaceutical industry to include anti-abuse properties in new medications. Drug companies seeking Food and Drug Administration (FDA) approval for medications that do not utilize abuse-deterrent technologies would be subject to  additional layers of expert review.  In addition, the FDA is directed to develop recommendations regarding education programs for prescribers of opioids. Finally, H.R. 4976 directs the FDA to finalize guidance to industry on the agency’s evaluation of abuse-deterrent properties in generic opioids.

Background

The United States is experiencing an epidemic of drug overdose deaths. Since 2000, the rate of deaths from drug overdoses has increased 137 percent, including a 200 percent increase in the rate of overdose deaths involving opioids (opioid pain relievers and heroin). During 2014, a total of 47,055 drug overdose deaths occurred in the United States, with more than 28,000 deaths involving some type of opioid, including heroin.[1]

According to the bill’s sponsor, “No single strategy can solve this problem – we need a comprehensive approach that builds on proven methods and innovative solutions to end the overprescribing of opioids, get drugs off our streets, and expand prevention and treatment efforts. This bipartisan legislation is another tool in our belt to combat the opioid epidemic by providing incentives for pharmaceutical companies to use anti-abuse technologies and create a plan to educate well-meaning doctors about the potential dangers of prescription opioids.”[2]

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[1] See CDC: Increases in Drug and Opioid Overdose Deaths – United States, 2000-2014
[2] See Rep. Maloney’s Press Release “Maloney Introduces Bipartisan Bill to Combat Overprescribing of Opioids, Incentivize Anti-Abuse Technologies” April 20, 2016.

Cost

A Congressional Budget Office (CBO) cost estimate is currently unavailable.

 

Additional Information

For questions or further information please contact Robert Goad with the House Republican Policy Committee by email or at 6-1831.