Opioids Action Plan
In February 2016, FDA Commissioner Robert Califf (then the deputy commissioner for medical products and tobacco) announced the FDA Opioids Action Plan. The plan focuses on policies aimed at reversing the opioid epidemic while still providing patients in pain access to effective pain relief. The FDA actions include:
- Convening an expert advisory committee before approving any new drug application for an opioid that does not have abuse-deterrent properties;
- Consulting with the Pediatric Advisory Committee about a framework for pediatric opioid labeling before any new labeling is approved;
- Updating the REMS requirements for ER/LA opioid analgesics after considering the advisory committee’s recommendations from a meeting held in May 2016 and reviewing existing requirements;
- Improving access to naloxone (by facilitating the development of an over-the-counter version of naloxone, which is currently available only by prescription, thereby making it more accessible to treat opioid overdose), and medication-assisted treatment options for patients with opioid use disorders; and
- Supporting better pain management options, including alternative, nonaddictive treatments for pain.
The FDA is conducting research on pain measurements for conditions such as chronic low back pain, osteoarthritis, diabetic neuropathy, postherpetic neuralgia, and fibromyalgia. The FDA is also working to support the development of nonopioid options for these patients.
Consistent with the plan, in March 2016, the FDA announced that it was requiring changes to the labeling on immediate-release opioids, including additional warnings and safety information that incorporate elements similar to the ER/LA opioid analgesics labeling. Furthermore, among other steps, the FDA has contracted with the National Academy of Medicine to provide advice on how to incorporate current evidence about the public health impact of opioid use (for patients who are prescribed opioids as well as for nonpatients) into regulatory activities concerning opioids.
The FDA shares the responsibility of keeping patients safe. Working with the health care community and federal and state partners to help reduce opioid misuse and abuse and improve appropriate opioid prescribing while ensuring that patients in pain continue to have appropriate access to opioid analgesics is a top priority for the FDA and part of the targeted approach of the HHS focused on prevention, treatment, and intervention.