FDA Outlines Action Plan on Opioid Abuse

FDA commissioner-nominee Robert Califf and other agency officials have outlined a far-reaching action plan to reassess its approach to opioid medications. Presumably, the timing of the plan addresses a hold on Califf’s nomination by Sen. Edward J. Markey (D-MA), who called for immediate reforms to the agency’s approval process for opioid painkillers (see earlier story). Sen. Kelly Ayotte (R-NH) recently said she will join Markey over opposition to opioids.



The plan, according to the agency, will focus on “policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief. FDA will:

Re-examine the risk-benefit paradigm for opioids and ensure that the agency considers their wider public health effects;Convene an expert advisory committee before approving any new drug application for an opioid that does not have abuse-deterrent properties;Assemble and consult with the Pediatric Advisory Committee regarding a framework for pediatric opioid labeling before any new labeling is approved; Develop changes to immediate-release opioid labeling, including additional warnings and safety information that incorporate elements similar to the extended-release/long-acting (ER/LA) opioid analgesics labeling that is currently required;    Update Risk Evaluation and Mitigation Strategy requirements for opioids after considering advisory committee recommendations and review of existing requirements;Expand access to, and encourage the development of, abuse-deterrent formulations of opioid products;Improve access to naloxone and medication-assisted treatment options for patients with  opioid use disorders; andSupport better pain management options, including alternative treatments.



“As one of the cornerstones of this plan,” the agency said, “the FDA will seek guidance from outside experts in the fields of pain management and drug abuse. For example, the FDA has already asked the National Academy of Medicine to help develop a framework for opioid review, approval and monitoring that balances individual need for pain control with considerations of the broader public health consequences of opioid misuse and abuse.”



Additionally, the plan calls for strengthening the requirements for drug companies to generate postmarket data on the long-term impact of using ER/LA opioids. The agency expects this to result in the most comprehensive data ever collected in the field of pain medicine and treatments for opioid use disorder. The data will further the understanding of the known serious risks of opioid misuse, abuse, overdose and death.

“Things are getting worse, not better, with the epidemic of opioid misuse, abuse and dependence,” Califf says. “It’s time we all took a step back to look at what is working and what we need to change to impact this crisis.”