In response to the current opioid-abuse epidemic, Dr. Robert Califf, the FDA’s Deputy Commissioner for Medical Products and Tobacco, along with other FDA leaders, has called for an action plan to reassess the agency’s approach to opioid medications.
The FDA intends to:
- Re-examine the risk–benefit paradigm for opioids and ensure that the agency considers the wider public health effects of these drugs
- Convene an expert advisory committee before approving new drug applications for an opioid that does not have abuse-deterrent properties
- Consult with the agency’s 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 the risk evaluation and mitigation strategy (REMS) 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-abuse disorders
- Support better pain management options, including alternative treatments
As one of the cornerstones of its plan, the FDA will seek guidance from outside experts in the fields of pain management and drug abuse. For example, the agency has already asked the National Academies of Sciences, Engineering, and Medicine to help develop a framework for opioid review, approval, and monitoring that balances an individual’s need for pain control with considerations of the broader public health consequences of opioid misuse and abuse.
In addition, the FDA will convene independent advisory committees composed of physicians and other experts when considering for approval any new opioid drugs that do not contain abuse-deterrent properties. The FDA will also convene a meeting of its standing Pediatric Advisory Committee to make recommendations regarding a framework for pediatric opioid labeling and the use of opioid pain medications in the pediatric population.
The FDA is also strengthening the requirements for drug companies to generate post-marketing data on the long-term effect of using ER/LA opioids. The agency expects this effort to result in the most comprehensive data ever collected in the field of pain medicine and treatments for opioid-abuse disorders. The data will further the understanding of the known serious risks of opioid misuse, abuse, overdose, and death, the agency says.
Drug overdose deaths, driven largely by overdose from prescription opioids and illicit drugs, such as heroin and illegally made fentanyl, are now the leading cause of injury death in the U.S.––surpassing motor vehicle crashes.
Source: FDA; February 4, 2016.