Contact: Becky Martin, 202-753-0428
Washington DC, March 2, 2016
The NPA appreciates the spirit of the FDA’s new ‘Opioids Action Plan’ announced on February 4, 2016 and has sent a letter to FDA Commissioner Dr. Robert M. Califf expressing support for recommendations made by Dr. Bruce Psaty, Chair of the Science Board, regarding regulatory changes to reduce opioid-related morbidity and mortality. The recommendations by Dr. Psaty and the Science Board included the following:
- Opioid labels should indicate a suggested maximum dose.
- FDA should clearly communicate that use of opioid analgesics for more than 90 days may not be safe or effective.
- FDA should overhaul the existing opioid Risk Evaluation and Mitigation Strategy (REMS).
In addition, NPA urges the following actions by the FDA to strengthen the Opioid Action Plan:
- FDA should convene scientific advisory committee meetings for all opioids (including but not limited to those with abuse-deterrent formulations) and committee recommendations should be adhered to;
- revise extended-release and immediate release opioid labels in the manner suggested by the Science Board; and
- overhaul the curriculum used in opioid REMS educational programs to explicitly clarify the lack of evidence regarding the safety and effectiveness of long-term opioid use.