ASA Submits Comments to FDA on Opioid REMS
(July 10, 2009)
ASA recently submitted comments to the Food and Drug Administration (FDA) in response to a Federal Register notice seeking guidance on the Agency’s proposed plan for developing Risk Evaluation and Mitigation Strategies (REMS) for certain long-acting and high-potency opioids. FDA has been holding various stakeholder meetings on this issue for several months to gain public feedback on how best to enact congressionally authorized options for reducing abuse, diversion and unintended deaths associated with opioid medications. ASA is concerned that if FDA enacts burdensome prescribing or certification requirements for only certain opioids, pain specialists will be overwhelmed with patients as primary care and other physicians opt out of prescribing these medications. In addition ASA believes such burdensome requirements will drive up abuse of other less-regulated opioids that are already the most commonly abused.
ASA’s Committee on Pain Medicine contributed considerably in the drafting of the comments.
THE AMERICAN SOCIETY OF ANESTHESIOLOGISTS
Anesthesiologists: Physicians providing the Lifeline of Modern Medicine TM. Founded in 1905, the American Society of Anesthesiologists is an educational, research and scientific association with more than 50,000 members organized to raise and maintain the standards of the medical practice of anesthesiology and improve the care of the patient.
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