FDA Commissioner Listening to Chronic Pain Patients

By Pat Anson, Editor

Chronic pain sufferers have long complained that they rarely get a seat at the table when important decisions are being made about opioid medication.

Last year President Trump’s opioid commission held five public hearings without ever inviting a patient, patient advocate or pain management physician to testify.  The Centers for Disease Control and Prevention also ignored the pain community in 2015 when it secretly drafted its opioid prescribing guideline, relying instead on the advice of addiction treatment specialists and anti-opioid activists.

Now there is a hopeful sign that at least one federal agency is starting to listen to patients about the worsening quality of pain care in the U.S.

The Food and Drug Administration is seeking comments from patients only on the challenges they face finding treatment and on the effectiveness of opioids and other types of pain medication. Patients are invited to submit their comments by mail or in the Federal Register, and to attend a public meeting on July 9. Click here for more details.

The meeting is the latest in a series of step ordered by FDA Commissioner Scott Gottlieb, MD, to get more public input on how to deal with the opioid crisis.  In January, dozens of pain patients and their advocates expressed their concerns to the FDA’s Opioid Policy Steering Committee.

“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 in an online blog.

“We’re focused on striking the right balance between reducing the rate of new addiction while providing appropriate access to those who need these medicines. In some medical circumstances, opioids are the only drugs that work for some patients. This might include patients with metastatic cancer or severe adhesive arachnoiditis.”



Gottlieb also signaled that the FDA is considering the development of prescribing guidelines for specific chronic pain conditions – not the one-size-fits-all approach taken by the CDC.

“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,” he wrote.

“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.”

Although Gottlieb has angered some in the pain community with his crackdowns on kratom and stem cell clinics, he does appear to have a sympathetic ear for pain sufferers. In 2012, a full five years before becoming FDA commissioner, Gottlieb warned that heavy-handed enforcement actions by the DEA were interfering with patient care.  

“This approach is burdening a lot of innocent patients, including those with legitimate prescriptions who may be profiled at the pharmacy counter and turned away. Others have in effect lost access to care, because their doctors became too wary to prescribe what their patients need,” Gottlieb wrote in a prophetic column published in The Wall Street Journal.

To leave a public comment for the FDA in the Federal Register, click here. Comments will be accepted until September 10, 2018.