The House Energy and Commerce Subcommittee on Health approved bipartisan legislation on Wednesday that was introduced by U.S. Rep. Leonard Lance (R-NJ) to reform the medical drug and label approval process to address the opioid and heroin abuse crisis.
The Opioid Review Modernization Act, H.R. 4976, would take steps to improve the medical drug approval and label process to help curb the nation’s opioid and drug abuse epidemic.
“Many New Jersey communities are struggling every day with the challenges of prescription opioid and heroin addiction,” Lance, a member of the subcommittee, said. “It is an epidemic crisis that is devastating urban and suburban families alike and straining law enforcement resources. Congress must ensure that our federal health agencies are working in concert with the medical and pharmaceutical communities and doing their part to help fight the scourge of heroin addiction.”
Lance’s bill would take steps to ensure rigorous FDA review of the benefits and risks of opioid medications, as well as how those risks will be communicated to prescribers and patients, during the drug approval process.
“While families, communities and local law enforcement are and should remain on the front lines against addiction, Congress has an important role as well,” Lance said. “The federal government should improve and strengthen regulations governing opioid prescriptions.”
The FDA would also be directed to work with expert advisory committees on product approval and labeling decisions. Additionally, the bill would encourage the development and approval opioid drugs with abuse-deterrent properties.