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NPA Recommends Enhancements to FDA’s Opioid Action Plan

Contact: Becky Martin, 202-753-0428

email: npa@npalliance.org

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:

  1. Opioid labels should indicate a suggested maximum dose.
  2. FDA should clearly communicate that use of opioid analgesics for more than 90 days may not be safe or effective.
  3. 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:

  1. 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;
  2. revise extended-release and immediate release opioid labels in the manner suggested by the Science Board; and
  3. 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.

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