By Ed Coghlan.
The FDA Public Meeting on Drug Development for Chronic Pain heard from an audience of chronic pain advocates and patients in Washington D.C. this week.
The FDA meeting was part of what the agency said is an effort to seek a balance on opioid access.
“While we work to ensure appropriate and rational prescribing of opioids, we won’t lose sight of the needs of Americans living with serious chronic pain or coping with pain at the end of life,” Dr. Scott Gottlieb, the FDA commissioner, said before the meeting. “They too face significant challenges.”
For chronic pain advocates, like Terri Lewis Ph.D. who shared the results of an extended survey that the National Pain Report promoted, the meeting Monday was a start.
“Now we find out if they listened,” she said. “The FDA heard from the people who have been caught in the federal government crackdown on opioids–the patients. It’s a voice not often heard, but it was today.
There is an unmet medical need experienced by patients with chronic pain.
“Collecting information from the patient’s experience provides an opportunity for the FDA to enhance regulatory decision-making”, she added.
For Cindy Steinberg of the US Pain Foundation—the nation’s largest pain patient advocacy group, the theme of what the FDA heard and what the agency will do now is also important.
“Anyone listening today heard a clear and resounding message from patients who traveled great distances to deliver it and will undoubtedly pay a cruel price in days of increased pain for doing so,” she said. “Their message was clear – we are sick with devastating pain conditions yet doctors will no longer treat us. We have been forced off opioid medications we have used appropriately that have helped us to function. We are suffering to the point that many of us are losing the will to live. Why don’t you hear our pleas and take action to stop this inhumane treatment?”
“My question now is what action the FDA will take to demonstrate that they care?” she told the National Pain Report.
Commissioner Gottlieb said the FDA is seeking a balance on opioid access and seemed to acknowledge the chronic pain patient has often been caught in the crossfire.
“As we consider new policy steps to address the opioid addiction crisis, the FDA remains focused on striking the right balance between reducing the rate of new addiction by decreasing exposure to opioids and rationalizing prescribing, while still enabling appropriate access to those patients who have legitimate medical need for these medicines,” he said.
For Lauren Deluca, who is President and Founder of the Chronic Illness Awareness Advocacy Group, the hearing was a good opportunity for the chronic pain patients to make their case, but she also is wary about the focus of the government hearing.
“I am so proud of hearing so many passionate advocates speak out against these egregious human right abuses. But I have my reservations about the FDA’s focus on drug development rather than the delivery of essential medical services that are clearly need right now,” she told the National Pain Report. “Drug Development is fine and good for the future but our community needs immediate action. I am hopeful to see some steps from the FDA and other regulatory bodies to ensure access as this is a consumer rights issue as well.”
For more on what the survey of chronic pain patients revealed, click here.
Did you attend the FDA hearing? What did you think about the hearing?
Contact me @editor@nationalpainreport w/ your comments and contact information.
Follow on Twitter: