Opioid analgesics are important pain medications that are widely prescribed for both non-cancer and cancer-related pain. Opioid drugs provide significant benefits for patients when used properly for their approved indications. However, opioids also carry a risk of abuse, misuse and death. More than 15,500 people died in the United States in 2009 after overdosing on narcotic pain relievers. That’s a 300 percent increase over the last 20 years. And for each death, there are an additional ten treatment admissions, 32 emergency department visits and 825 nonmedical users of these drugs. FDA is extremely concerned about the inappropriate use of opioids, which has become a major public health challenge for our nation.


An impassioned, sometimes heated, debate has occurred in the medical and health policy communities about the best ways to ensure that opioids are used appropriately while working to prevent any further tragedies. As FDA reviews opioid medical products, requires accurate drug prescribing information, and monitors how these products are used once they go to market, the agency must strike a balance between their benefit in treating patients with moderate to severe pain and the risks associated with misuse, abuse and addiction to those patients and to others.  Combating opioid misuse, abuse, and addiction has long been a priority for the Agency, and FDA has taken many steps to address this problem over the last few decades.


However, FDA recognizes that we can do more and has established a task force to build upon existing initiatives and develop new ones. The task force has embarked on a multi-pronged and targeted approach aimed at combating misuse, abuse and addiction at critical points in the lifecycle of an opioid product, from development through use. The task force’s multi-pronged approach currently targets:


Posted on the FDA website on 6 February 2013