The Washington Post – The Food and Drug Administration is ramping up scrutiny of anti-abuse features on opioid painkillers to try to determine if they actually do what they're intended to do.
On Tuesday, the agency announced a two-day public meeting that will focus on whether the agency has “the right information to determine whether these products are having their intended impact on limiting abuse and helping to curb the epidemic,” according to an accompanying statement by FDA Commissioner Scott Gottlieb.
The meetings, detailed in a Federal Register notice, are scheduled for July 10-11.
Gottlieb called abuse-deterrent formulations — protections such as special coatings or additives to blunt a drug's euphoric effects when the medication is manipulated — an important focus for the agency. But he said there is a gap in understanding whether “these products result in a real-world, meaningful decrease in the frequency and patterns of opioid misuse and abuse.” The FDA requires companies selling abuse-deterrent medications to conduct post-approval studies assessing their impact, but such studies are challenging, he added.
Read more at The Washington Post.