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Under pressure, FDA taking new tack on opioids

February 5, 2016
by Julie Miller, Editor in Chief
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This week, Robert Califf, FDA’s deputy commissioner for medical products and tobacco, vowed to retool the agency’s approach to opioid medications. Balancing the need for pain control against the risk of addiction will be a challenge, as there are powerful advocates in both camps.

FDA has come under fire in recent years for several of its new drug approvals, such as Zohydro ER, which the agency approved even though its own advisory committee voted 12-to-2 against it.

According to a release, 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 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; and

  • Support better pain management options, including alternative treatments.

The agency says it will seek guidance from outside experts in the fields of pain management and drug abuse and will convene independent advisory committees.

 Drug companies will have new marching orders to generate postmarket data on the long-term impact of using extended release or long acting 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,” said Califf in a statement. “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.”