FDA Announces New Labeling and Postmarket Studies Requirements for Painkillers

On September 10, 2013, the FDA announced its plan to issue new regulations for labeling extended-release and long-acting (ER/LA) opioid analgesics intended to treat pain.  According to the FDA, the labeling changes “will include important new language to help health care professionals tailor their prescribing decisions based on a patient’s individual needs.”

The proposed changes are meant to help curb the growing epidemic of painkiller abuse.  Labels for ER/LA opioid analgesics (drugs such as morphine, oxycodone, and fentanyl) currently indicate that such drugs are for patients with moderate to severe pain.  The new regulations will require the labels to indicate that the drugs should only be used for pain severe enough to require daily, around-the-clock, long-term opioid treatment, and should only be used for patients for whom alternative treatment options are ineffective or insufficient to manage their pain.  The new regulations will also require a new boxed warning on ER/LA opioid analgesics to inform health care professionals that the use of these drugs during pregnancy may result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening in newborns.

The FDA also announced a new postmarket studies requirement to be imposed on drug companies that make ER/LA opioid analgesics.  These postmarket studies and clinical trials are intended to further assess questions about the risks and benefits of ER/LA opioid analgesics.  Through these initiatives, the FDA aims to achieve safer and more appropriate prescription painkiller use.