The FDA has announced a new action plan designed to reassess their approach to opioid medications. The agency has identified 8 major changes that they hope will reverse the epidemic whilst still providing patients access to pain relief. One of the most noteworthy changes is their decision, going forward, to work with outside experts to assess the public health consequences of opioids. In fact, the FDA have already asked the National Academies of Sciences, Engineering, and Medicine to help develop a framework for opioid review, approval and monitoring.
Another new aspect to be adopted will be the establishment of independent advisory committees to consider any approval for new opioid drugs that do not contain abuse-deterrent properties. “We are determined to help defeat this epidemic through a science-based and continuously evolving approach,” said Dr. Robert Califf, the FDA’s Deputy Commissioner for Medical Products and Tabacco. “This plan contains real measures this agency can take to make a difference in the lives of so many people who are struggling under the weight of this terrible crisis.
The FDA is also increasing their requirements on drug companies to generate postmarket data on the long-term impact of using ER/LA opioids. Officials predict this will result in the most comprehensive data ever collected for pain medicine and treatments.
Here are the 8 new measures, in their entirety, as outlined by the FDA:
- 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; and
- Support better pain management options, including alternative treatments.
These changes come in the wake of a growing body of research associating higher rates of overdoses in those individuals prescribed opioids. The FDA’s changes fall within a national initiative by the US Health and Human Services (HHS) to address opioid abuse. Commenting on what sparked the agencies major rethink on opioids, Dr. Califf said, “Things are getting worse, not better, with the epidemic of opioid misuse, abuse and dependence, 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.”
For more information visit FDA.gov.