Expert panel to FDA: time to hold opioids to a new standard

To help bolster its campaign against an epidemic of opioid abuse that now kills about 90 people a day, the U.S. Food and Drug Administration (FDA) last year called for help from an independent advisory panel. The resulting report, released today by the National Academies of Sciences, Engineering, and Medicine, makes some strong prescriptions. Among its assorted recommendations—from supporting state syringe exchange programs to increasing federal funding for neurobiology research—the panel suggests that FDA dramatically expand the types of evidence it requires from companies to show that an opioid is safe and effective, both before and after it gets market approval. The new framework would require companies to provide complex data on a drug’s public health impact—potentially including its ability to ensnare people at high risk of addiction as well as shift the dynamics of the illegal drug market

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