FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Opioid Committee to Hold January Meeting on Prescribing Interventions

Dec. 14, 2017
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The FDA’s Opioid Policy Steering Committee will hold a Jan. 30 public meeting to discuss prescribing interventions for opioids.

The committee will invite stakeholder comments on strategies for promoting the safe use of opioid analgesics under the agency’s REMS authority. The agency is particularly seeking feedback on how to ensure any intervention creates a minimal burden for patient access.

For example, a REMS could impact prescribing by requiring that sponsors ensure that prescribers provide specific documentation for a prescription above a specified amount, such as a statement that the quantity prescribed is medically necessary for the patient.

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