FDA Seeks to Establish REMS for Opioid Drugs

Rockville, MD (Feb.  6)-The US Food and Drug Administration 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). FDA has authority to require a REMS under the Food and Drug Administration Amendments Act of 2007 when necessary to ensure that the benefits of a drug outweigh the risks.

The affected opioid drugs include brand name and generic products and are formulated with the active ingredients fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone. A listing of the affected drugs may be found here.

FDA asserts that establishing a REMS for opioids will reduce risks while ensuring that patients with legitimate need for these drugs will continue to have appropriate access. FDA points out that the agency,  drug manufacturers, and others have taken steps to prevent misuse, abuse and accidental overdose of these drugs, including providing additional warnings in product labeling, implementing risk management plans, conducting interagency collaborations, and issuing direct communications to prescribers and patients. Despite these efforts, the rates of misuse and abuse, and of accidental overdose of opioids, have risen over the past decade, according to FDA.

FDA has invited those companies that market the affected opioid drugs to a meeting with the agency on March 3 to discuss REMS development. Additional steps will include discussions with other federal agencies and nongovernment institutions, including patient and consumer advocates, representatives of the pain and addiction treatment communities, other healthcare professionals, and other interested parties.

FDA is planning a public meeting in late spring or early summer to allow for broader public input and participation.

“Through this process, FDA hopes to gain valuable information that will lead to practical and effective solutions for development of a REMS and for appropriate use of these opioid drug products,” said the agency in an agency communication.