ASA Raises Concerns to FDA about Proposed Changes to Opioid Labeling

On February 7, ASA offered oral comments at a Food and Drug Administration (FDA) public hearing on the impact of approved drug labeling on chronic opioid therapy.  FDA held the hearing principally to discuss a petition filed by Physicians for Responsible Opioid Prescribing (PROP), which requests that the FDA make the following changes to opioid labels:

1. Strike the term "moderate" from the indication for non-cancer pain.

2. Add a maximum daily dose, equivalent to 100 milligrams of morphine for non-cancer pain.

3. Add a maximum duration of 90-days for continuous (daily) use for non-cancer pain.

 
In a formal communication to FDA in August 2012, ASA "support[ed] the broad concept that high dose opioids should not be used to treat chronic non-cancer pain."  However, ASA argued that "placing specific limits on daily doses of opioids that a physician may prescribe is not scientifically founded nor is it practical."  Daniel Carr, M.D., professor of anesthesiology, Medicine and Public Health at Tufts University School of Medicine and member of ASA's Committee on Pain Medicine, highlighted and expanded upon ASA's concerns with PROP's proposal at the FDA meeting.  Dr. Carr noted that:

• It can be difficult to define cancer versus non-cancer pain because treatments for cancer often lead to chronic pain;
• It is unclear what proportion of the time pain would need to be reported as "severe" in order to justify prescribing an opioid, and it is very common for pain intensity to fluctuate between moderate and severe during treatment;
• The population-based conversion factors used to calculate "equivalent" morphine doses in patients treated with non-morphine opioids differ from patient to patient, and even in the same patient followed across time when renal or hepatic function vary;
• Opioids for moderate pain, high dose opioids, or opioids taken for longer than 90 days appear to be effective and well-tolerated for certain patients;  and
• Pain treatment physicians care for complex patients whose problems have persisted or worsened during non-specialist care, and mandating limits on opioid dosage and duration would add difficulty to anesthesiologists’ already-challenging task of caring for these patients. 

Douglas Throckmorton, M.D., deputy center director of the Center for Drug Evaluation and Research at the FDA led the two-day meeting.  Other presenters at the FDA meeting included medical societies, clinicians, patients who suffer from chronic non-cancer pain that is controlled by opioids and parents who lost their children to an opioid-related overdose.

ASA will continue monitoring the FDA’s response to the PROP petition.  Visit our pain medicine advocacy webpage to learn more about ASA’s advocacy on behalf of our members who practice pain medicine.