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.
FDA has already made some moves to fight opioid addiction. Last month, it asked drugmaker Endo International to withdraw its long-lasting painkiller Opana ER from the market after finding that the new formulation had led to increases in intravenous abuse. This week, it announced that it would subject a broader range of opioids to its Risk Evaluation and Mitigation Strategy requirement, which includes requiring companies to do more to educate physicians about risks and prescribing practices.
But an even broader overhaul is needed, says public health policy expert Aaron Kesselheim of Harvard University, one of the members of the panel that drafted the new opioid report. He recently spoke with ScienceInsider about the panel’s recommendations. The interview has been edited for brevity and clarity.