FDA’s new action plan addresses opioid abuse epidemic

The U.S. Food and Drug Administration’s (FDA) new action plan on opioids will re-examine the risk-benefit paradigm for opioids, and ensure that the agency considers their wider public health effects when assessing new drugs for approval.

Other components of the FDA’s plan include:

• Developing changes to labeling for immediate-release opioids to provide better information for physicians about their risks and how to prescribe safely.
• Updating the Risk Evaluation and Mitigation Strategy Program requirements for opioids after considering advisory committee recommendations and review of existing requirements to increase the number of prescribers who receive training.
• Strengthening the requirements for drug companies to generate post-market data on the long-term impact of using ER/LA opioids.
• Reviewing options, including over-the-counter availability, to make naloxone more accessible to treat opioid overdose, building on the agency’s recent approval of intranasal naloxone.

The new action plan follows a White House announcement that proposes $1.1 billion in funding to fight this epidemic.

The AOA continues to focus substantial efforts in support of addressing the opioid abuse epidemic, including highlighting non-pharmacological approaches to treatment of pain such as OMM/OMT.