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The Opioid Review Modernization Act requires drug companies to obtain additional levels of expert approval when seeking Food and Drug Administration 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. The legislation is set to be included in a package of legislation, including the Comprehensive Addiction and Recovery Act, heading to a conference committee in 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 Maloney, whose district covers parts of Westchester, Rockland, Putnam and Dutchess counties. “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 legislation would require the FDA to establish an advisory committee to evaluate new drugs that do not contain abuse-deterrent properties. If pharmaceutical producers choose to include abuse-deterrent components in new medicines, they would have the option to bypass the committee.
The bill would also require the FDA to develop a suggested curriculum for doctors who prescribe opioids. Currently, no comprehensive strategy exists to ensure all doctors are aware of the potential for abuse in opioid-based medication.
Earlier this year, Maloney held a telephone town hall on the heroin and opioid epidemic with more than 21,000 Hudson Valley residents.
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