The FDA will publish guidance on abuse-deterrent opioids by the end of June, in order to avoid a $20 million cut in funds to the commissioner’s office threatened by Congress. An amendment by Hal Rogers (R-KY) to the “Consolidation and Further Continuing Appropriations Act” passed last December requires that the guidance be finalized by June 30th, 2015, otherwise $20 million will be moved from the salaries and expenses section of the FDA Commissioner’s office to its criminal investigations department to combat drug diversion. Guidance was initially released in January 2013, but the agency didn’t hold a workshop on the draft document until a 2-day meeting last October. The agency noted last Fall that it plans to continue to evaluate approvals on a case-by-case basis, citing the fact that the science of abuse-deterrence is still unsettled.
Read the full feature from MedPage Today here.