When the U.S. Food and Drug Administration screens new opioid drugs it should better anticipate how people might abuse them in the real world, the National Academies of Sciences, Engineering and Medicine warns in a major report issued Thursday on the country’s opioid crisis, which kills 91 people a day—often via overdoses on prescription drugs. The FDA needs to move beyond its traditional focus on clinical studies about drug effectiveness and side effects, and to seek public health data on potential abuse, the Academies advises in its 400-page proposal for targeting the deadly issue.
The FDA had asked for the report, and its release comes as several states are suing pharmaceutical companies over allegations that they downplayed the addictive nature of certain prescription painkillers and helped fuel the current crisis. “The focus of the request from the FDA was for advice on what they could do to evaluate [opioids] more completely before approving them for use,” says Stanford University anesthesiology professor David Clark, a member of the Academies committee that drafted the report. A key recommendation, Clark says, is for “the FDA to move beyond its standard matrix of considerations for drug safety and—at least for opioids—move into a more public health–centered matrix of considerations which could help us predict what might happen for people beyond the intended recipient of the drug.”
Comment;
This seems like a sensible, rational approach. The pharmaceutical industry will be furious and fight tooth and nail!
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