FDA Plans Public Workshop to Evaluate Studies of Abuse-Deterrent Opioid Use
The FDA is planning a public workshop in July to evaluate the impact of abuse-deterrent formulations of opioid painkillers, and to find ways to better inform the agency’s regulatory approach, following recently renewed calls to action.
Commissioner Scott Gottlieb said the meeting will be an important chance for the agency to explore whether they are gathering the proper information to measure effects on abuse, such as data from sponsor-led postmarketing studies.
Gottlieb addressed what he described as “a gap in our understanding” on whether abuse-deterrent formulations are effective, such as manufacturing additions that make tablets difficult to crush into a powder or mix with water.
At the two-day meeting, starting July 10, the FDA plans to discuss better ways to use existing data sources and methods to measure real-world impact, as well as new study designs to inform regulatory decisions.