In response to the opioid abuse epidemic, Dr. Robert Califf, the FDA’s deputy commissioner for medical products and tobacco, along with other FDA leaders, called for a far-reaching action plan to reassess the agency’s approach to opioid medications.
The plan will focus on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief. As one of the cornerstones, 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.
In addition, the FDA will convene independent advisory committees made up 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 use of opioid pain medications in the pediatric population.
The FDA is also strengthening the requirements for drug companies to generate post-market 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.
The evidence-based initiative focuses on three promising areas: informing opioid prescribing practices; increasing the use of naloxone, building on the FDA’s recent approvals of injectable and intranasal naloxone; and using medication-assisted treatment to move people out of opioid addiction. The FDA’s call to action is also supportive of the Centers for Disease Control and Prevention’s current work on guidelines for prescribing of opioids for the treatment of chronic pain outside of end of life care.
Opioids are a class of drugs that include prescription medications such as oxycodone, hydrocodone, and morphine, as well as the illicit drug heroin.
Drug overdose deaths, driven largely by overdose from prescription opioids and illicit drugs like heroin and illegally-made fentanyl, are now the leading cause of injury death in the United States – surpassing motor vehicle crashes.
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