On opioid labeling, FDA emphasizes patient-physician relationship

| 1 Min Read

Statement attributable to:
Bobby Mukkamala, M.D.
President, American Medical Association 

“The FDA’s requirement on opioid labels appropriately focuses on physicians making individualized, informed decisions about opioid prescribing while supporting informed decision-making for patients. The AMA agrees that decisions whether to begin opioid therapy must be made on whether the benefits outweigh the known risks. We agree that—if opioid therapy is indicated—physicians should start low and go slow. We further agree with the FDA that rapid escalations and rapid discontinuation should not occur to avoid patient harm.

 “The new FDA label continues the approach laid out by CDC in its 2022 opioid prescribing guideline emphasizing the importance of individualized, shared decision-making between the patient and physician.

 “The AMA and our Substance Use and Pain Care Task Force continue to support pharmacotherapy and nonpharmacotherapy options that are based on the physician’s best medical judgment and individualized patient characteristics. This approach has been instrumental in the dramatic reduction in opioid prescriptions and opioid fatalities. We will continue to pursue policies with our federal partners that offer appropriate relief to our patients with pain.”

 Our letter to the FDA on the proposed labeling can be found here.

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About the American Medical Association

The American Medical Association is the physicians’ powerful ally in patient care. As the only medical association that convenes 190+ state and specialty medical societies and other critical stakeholders, the AMA represents physicians with a unified voice to all key players in health care.  The AMA leverages its strength by removing the obstacles that interfere with patient care, leading the charge to prevent chronic disease and confront public health crises and, driving the future of medicine to tackle the biggest challenges in health care.

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