FDAnews
www.fdanews.com/articles/177483-house-senate-conferees-leave-two-critical-drug-elements-in-opioid-bill-unchanged

House, Senate Conferees Leave Two Critical Drug Elements in Opioid Bill Unchanged

July 12, 2016

The House and Senate conferees met last week to mark up the Comprehensive Addiction and Recovery Act, making a few changes but leaving intact two critical elements related to opioid approval and FDA oversight.

The first element concerns efforts to incentivize the development of abuse-deterrent opioids by amending the Social Security Act to exclude abuse-deterrent formulations from the Medicaid additional rebate requirement for new prescription drugs.

The other is a provision that would require the FDA to convene an advisory committee to review investigational opioid medications, one that also appeared in the original Senate CARA bill (S. 524) and the House’s Opioid Review Modernization Act of 2016 (H.R. 4976).

View today's stories