On February 4, Robert Califf, MD, FDA’s Deputy Commissioner for Medical Products and Tobacco, released a new plan to reassess the Agency’s approach to opioid regulation. The plan includes a number of new policies which are intended to “reverse” the current opioid epidemic in the United States, “while still providing patients with pain access to effective relief.”
Opioids relieve pain by reducing the “intensity of pain signals reaching the brain and affect those brain areas controlling emotion, which diminishes the effects of a painful stimulus,” have a high rate of abuse, addiction, and overdose. Examples of opioids include prescription medications such as oxycodone, hydrocodone, and morphine, as well as the illicit drug heroin.
These drugs have a high rate of abuse, addiction, and overdose, and when prescribed to patients who should not receive them, or when used improperly or for recreational purposes, they can cause serious harm, including overdose and death. In the recent past, opioid overdose has become a leading cause of death in the US, making opioid abuse a primary concern for many, including US regulators.
According to the recently stated plan, “the 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; and
- Support better pain management options, including alternative treatments.”
Furthermore, the plan states that the FDA will “seek guidance from outside experts in the fields of pain management and drug abuse.” The Agency’s recent press release stated that it has already asked the National Academy of Medicine to assist with the development of “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 the press release, Califf said the Agency is determined to overcome this epidemic, and plans to do so using a continuously evolving, science-based approach. “’Things are getting worse, not better, with the epidemic of opioid misuse, abuse and dependence,’ added Califf. ‘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.’”
The Weinberg Group has a 35-year track record of helping our clients achieve successful interactions with the FDA and we have the experience you need to do exactly that. Contact us today to learn more about our services and how we can help you develop and submit a successful application.
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