Called too lax on opioid approvals, FDA floats new criteria

The FDA has taken heat for approving powerful painkillers that have fueled the opioid crisis and its trail of addiction, overdoses, infections among people who inject drugs. The agency has also come under fire from people desperate to ease their chronic pain. To walk the line between those competing concerns, the FDA outlined its plans yesterday for approving new opioid medications. Open to comment for 60 days, the draft would weigh the broader health consequences of a new drug and compare it to existing painkillers. Drug makers would have to lay out how their proposed drug would reduce the known risks of overdose, misuse, or addiction, compared to drugs already available — and any new risks their drug might pose. More for STAT Plus subscribers here.