FDA proposes tighter opioid rules that would make new drugs less addictive

The Food and Drug Administration is proposing to tighten the rules for opioid manufacturers by requiring new drugs to be less addictive.

Acting FDA Commissioner Ned Sharpless withdrew the agency’s previous guidance Thursday, laying out a tougher new regulatory framework for evaluating applications for new opioids coming to the U.S. market. Under the proposal, drugmakers would have to say whether their drug has “any characteristics that would mitigate the risks of overdose, abuse or the development of addiction.”