By Ed Coghlan
The U.S. Food and Drug Administration wants to create an action plan that can “reassess the agency’s approach to opioid medications.
According to the email the FDA distributed Thursday night, “the plan will focus on policies aimed at reversing the (opioid) epidemic, while still providing patients in pain access to effective relief.”
Already, chronic pain advocates are asking one question.
“What is the patient’s role in this action plan?”
Terri Lewis, Ph.D., who studies how the U.S. health care system treats chronic illness like chronic pain, was characteristically blunt.
“What’s missing? Once again, no patient voice,” she told the National Pain Report.
What caught Dr. Lewis’ attention was that declaration by the FDA that it will convene a panel of experts, without any reference to the patient point of view. Here’s how the release described the FDA efforts:
“As one of the cornerstones of this plan, 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.”
Dr. Lewis, who is a daughter and mother of people who have suffered or currently suffer from chronic pain, believes that the patient’s voice needs to be heard.
“When FDA accepts direct patient reports of serious adverse events, we have something to talk about,” she said. “When FDA penalizes health providers for NOT REPORTING information, we have something to talk about. Until then we have no real time reporting and will never be able to connect the dots.”
According to the FDA it 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.
The FDA also claims that strengthening the requirements for drug companies to generate post-market data on the long-term impact of using ER/LA opioids. The agency says it expects this to result in the most comprehensive data ever collected in the field of pain medicine and treatments for opioid use disorder.
Dr. Lewis says the FDA doesn’t appear to care what the patient thinks.
“FDA does not incorporate reports filed into the system from consumers because they consider them to unreliable,” she said. “That’s bunk.”