Congressman Sean Maloney

Representing the 18th District of New York

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Maloney’s Bill to Combat Opioid Abuse Unanimously Passes the House

May 11, 2016
Press Release
Legislation Would Curb Overprescribing of Opioids, Incentivize Anti-Abuse Technologies

Washington – The House of Representatives today unanimously passed Representative Sean Patrick Maloney’s (NY-18) legislation to combat opioid abuse by improving education for prescribing physicians and incentivizing the pharmaceutical industry to include anti-abuse properties in new medications. The Opioid Review Modernization Act would require drug companies to obtain additional levels of expert approval when seeking Food and Drug Administration (FDA) approval for medications that do not use abuse-deterrent technologies, like extended-release capsules. In addition, it would create a strategy for educating well-meaning physicians about the potential harms in prescribing opioids. This legislation is set to be included in a package of legislation, including the Comprehensive Addiction and Recovery Act (CARA), heading to a conference committee with the Senate.

“No single strategy can solve this crisis - we need a comprehensive approach that builds on proven methods and innovative solutions to end the flood of opioids in our communities, get drugs off our streets, and expand prevention and treatment efforts,” said Rep. Maloney. “As part of an all-around package of legislation to combat the opioid epidemic, my bill is a tool in our tool belt - providing incentives for pharmaceutical companies to use anti-abuse technologies and create a plan to educate our well-meaning doctors about the potential dangers of prescription opioids.”

The Opioid Review Modernization Act would require the Food and Drug Administration (FDA) to establish an advisory committee to evaluate new drugs which do not contain abuse-deterrent properties. The committee would also solicit outside input and provide a period for public comments. If pharmaceutical producers choose to include abuse-deterrent components in new medicines, they would have the option to bypass the committee. This process would incentivize the use of abuse-deterrent technology in new medication by offering an expedited path to approval. The bill would also require the FDA to develop a suggested curriculum for doctors who prescribe opioids as part of the agency’s Risk Evaluation and Mitigation Strategy (REMS). Currently, no comprehensive strategy exists to ensure all doctors are aware of the potential for abuse inherent in opioid-based medication.

Earlier this year, Rep. Maloney introduced another bill to combat the opioid epidemic; the Keeping Communities Safe Through Treatment Act would provide law enforcement with the option to divert low-level drug offenders directly to treatment instead of booking them and sending them through the criminal justice system. In early April, law enforcement personnel from throughout the Hudson Valley joined Rep. Maloney to call for passage of the bill. Additionally, the Orange County Legislature passed a resolution supporting the bill and calling on Congress to take action. Earlier this year, Rep. Maloney held a telephone town hall on the heroin and opioid epidemic with over 21,000 Hudson Valley residents.