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U.S. Department of Health and Human Services

Drugs

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Background on Opioid REMS

On February 6, 2009, FDA sent letters to manufacturers of certain opioid drug products, indicating that these drugs will be required to have a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drugs continue to outweigh the risks (Opioid REMS Meeting Invitation Template (PDF - 18KB); Opioids Products Chart). The affected opioid drugs include long-acting and extended-release brand name and generic products and are formulated with the active ingredients fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone.

Under the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Public Law 110-85), FDA has the authority to require persons submitting certain drug approval applications to submit a proposed REMS as part of the application. FDA may require a REMS when necessary to ensure that the benefits of a drug outweigh its risks. FDAAA also authorizes FDA to require holders of certain drug applications approved without a REMS to submit a proposed REMS if the agency becomes aware of new safety information and makes a determination that a REMS is necessary to ensure the benefits of the drug outweigh its risks.

Opioid drugs have benefit when used properly and are a necessary component of pain management for certain patients. Opioid drugs have serious risks when used improperly. In the past, FDA, drug manufacturers, and others have taken a number of steps to prevent misuse, abuse and accidental overdose of these drugs, including providing additional warnings in product labeling, implementing risk management plans, conducting inter-agency collaborations and issuing direct communications to both prescribers and patients. Despite these efforts, the rates of misuse and abuse, and of accidental overdose of opioids, have risen over the past decade. FDA believes that establishing a REMS for opioids will reduce these risks while ensuring that patients with legitimate need for these drugs will continue to have appropriate access.

FDA recognizes the need to achieve balance between appropriate access and risk mitigation and believes an effective risk management strategy would benefit from input from industry, patient advocacy groups, the pain and addiction treatment communities, the general public, and other stakeholders. Through this process, FDA hopes to gain valuable information that will lead to practical and effective solutions for developing a REMS and for appropriate use of these opioid drug products.

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