BOX 6-4Recommendation for the Approval Stage

Recommendation 6-4. Increase the transparency of regulatory decisions for opioids in light of the committee's proposed systems approach (Recommendation 6-1). The U.S. Food and Drug Administration should commit to increasing the transparency of its regulatory decisions for opioids to better inform manufacturers and the public about optimal incorporation of public health considerations into the clinical development and use of opioid products.

Steps that the FDA might take to implement this recommendation include

  • Issuing a guidance document that outlines opioid-specific clinical development considerations, including how the new guidance differs from existing analgesic development guidance and relates to public health.
  • Releasing summary versions of complete response letters for opioid products to inform the public about the public health considerations that the FDA has determined would preclude marketing approval.

From: 6, Opioid Approval and Monitoring by the U.S. Food and Drug Administration

Cover of Pain Management and the Opioid Epidemic
Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use.
National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse; Phillips JK, Ford MA, Bonnie RJ, editors.
Washington (DC): National Academies Press (US); 2017 Jul 13.
Copyright 2017 by the National Academy of Sciences. All rights reserved.

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