In a blog post published on Monday, Scott Gottlieb, the Food and Drug Administration commissioner, said the FDA is listening to opioid-related concerns from patients with chronic pain.
“We’ve heard the concerns expressed by these individuals about having continued access to necessary pain medication, the fear of being stigmatized as an addict, challenges in finding health care professionals willing to work with or even prescribe opioids, and sadly, for some patients, increased thoughts of or actual suicide because crushing pain was resulting in a loss of quality of life,” Gottlieb wrote.
Over a year ago, the FDA created the Opioid Policy Steering Committee with the goal of reducing exposure to opioids, preventing more addictions and developing and cultivating the use of medications to treat opioid addiction. This committee received public input from patients who use opioids to manage their chronic pain.
Now, the FDA is asking for input from chronic pain patients again to learn more about the “impacts of chronic pain, [patient] views on treatment approaches for chronic pain, and the challenges or barriers they face accessing treatments.”
Gottlieb said the FDA wants to “strike the right balance” between making policies that give patients who need opioids the proper accessibility and preventing opioid exposures that lead to new addictions.
Most patients with chronic pain do not develop an addiction. While studies vary on percentages, one study stated that less than 1 percent of those who take opioids long-term develop an addiction. Another study said 8 to 12 percent of people with chronic pain develop an addiction. This study also said that misuse (but not addiction) of opioids among chronic pain patients can be between 21 to 29 percent.
The FDA is considering coming up with a strategy in the next few months to encourage medical professional societies to create evidence-based guidelines on how to prescribe medications for acute medical needs and assess prescribing behavior as well as adding new prescribing information to opioid labels.
We believe such guidelines could encourage the use of an appropriate dose and duration of an opioid for some common procedures and promote more rational prescribing, including that patients are not being under prescribed and patients in pain who need opioid analgesics are not caught in the cross hairs. In short, having sound, evidence-based information to inform prescribing can help ensure that patients aren’t over prescribed these drugs; while at the same time also making sure that patients with appropriate needs for short and, in some cases, longer-term use of these medicines are not denied access to necessary treatments.
The Centers for Disease Control and Prevention published guidelines for prescribing opioids for chronic pain in 2016. The guidelines were not well received by patients, who said the guidelines led to less doctors prescribing opioids for their pain.
Gottlieb also said the FDA will be developing guidance documents for the most efficient path for developing drugs that can be used to treat various types of pain. This is an effort to promote more drug innovation for pain.
Patients with chronic pain can attend the FDA’s “Patient-Focused Drug Development for Chronic Pain” meeting on July 9 from 10 a.m. to 4 p.m. Patients can attend in person in Maryland or through a webinar by registering online.