FDA advisory committee's preferred approaches – linking mandatory training to DEA registration or state medical board licensing – are outside agency's existing regulatory authority.

Abuse-deterrent opioids address a serious unmet need and help differentiate brands from the field of generics, but so far Purdue’s OxyContin remains the only opioid on the market with abuse-deterrent claims, even though FDA recently approved two new opioid analgesics.

US FDA proposed increasing staffing and resources for both programs during the next user fee program cycle, but industry representatives did not believe it necessary.