FDA to Meet with Drug Companies about REMS for Certain Opioid Drugs
The Food and Drug Administration (FDA) has notified 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. The affected opioid drugs include brand
name and generic products and are formulated with the active ingredients
fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone.
The FDA, drug manufacturers, and others have taken a number of steps in the
past 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.
The FDA believes that establishing a REMS for opioids will reduce these risks, while
still ensuring that patients with legitimate need for these drugs will continue to
have appropriate access.
In the first of a series of meetings with stakeholders, the FDA has invited those
companies that market the affected opioid drugs to a meeting with the agency on
March 3, 2009 to discuss REMS development. Additional steps will include
discussions with other federal agencies and non-government institutions, including
patient and consumer advocates, representatives of the pain and addiction
treatment communities, other health care 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.
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