The American Medical Association (AMA), the nation’s largest doctors group, has gone on record opposing more restrictive labeling requirements for opioid painkillers, saying there is “no valid scientific basis” for them.
A letter to the Food and Drug Administration, signed by AMA Executive Vice President and CEO James Madara, urges the agency to reject a citizen petition filed last year by Physicians for Responsible Opioid Prescribing (PROP), which calls for major changes in the way opioids are prescribed to help end a wave of prescription drug abuse and deaths.
The AMA letter was dated and submitted to the FDA on April 9, but did not become publicly known until this week.
PROP’s petition asks the FDA to label most opioid painkillers for severe pain only, replacing current guidelines indicating they are suitable for both moderate and severe pain.
“The treatment of pain cannot be fit into a one-size-fits-all approach,” Madara said in his letter to FDA Commissioner Margaret Hamburg . “The AMA is especially concerned, therefore, about PROP’s recommendation to limit the labeled indications for opioid analgesics to “severe” instead of “moderate-to-severe” non-cancer pain. Pain intensity assessments are entirely subjective and rely upon patients’ own reports. One person’s “moderate” is another person’s “severe.”
Madara also objected to PROP’s proposal to limit opioid prescriptions to 90 days, saying that “would effectively eliminate the use of opioids for chronic non-cancer pain.”
PROP’s founder, Dr. Andrew Kolodny, maintains that doctors would still be able to prescribe opioids “off-label” after 90 days, but critics say many physicians would be reluctant to do so – fearing legal or even criminal liability if a patient becomes addicted or overdoses.
“Such a labeling change clearly would affect patients seeking medically necessary pain relief and increase the risk that prescribing physicians could be branded as practicing outside of accepted medical standards,” Madara said.
He also rejected PROP’s proposal to limit the maximum daily dose of an opioid to the equivalent of 100 milligrams of morphine, saying that “arbitrarily setting a maximum daily limit through regulatory edict is not a sound approach.”
Kolodny told National Pain Report the Madara letter does not reflect the views of AMA members and suggested the pharmaceutical industry was behind it.
“The position outlined in the letter does not reflect views of AMA membership. The positions were not arrived at with any input from the relevant AMA committees or with any input from membership whatsoever. The letter was written at the request of special interest groups and they reflect the views of special interest groups,” Kolodny said.
“Some of the language in that letter is the exact same language that industry has been using to argue against our petition. It looks very much like a position that a pharmaceutical company would be interested in, not something that AMA members would be arguing for.”
“There is not a single AMA member with expertise in the field of pain or addiction or primary care who was asked by AMA for formal input on this,” he added.
A few other physicians’ organizations have already gone on record opposing the PROP petition, but the AMA’s opposition would be the most significant.
Despite that opposition, the FDA is under growing political pressure to accept some type of labeling change.
In a letter last month to the FDA, the Drug Enforcement Administration expressed support for the PROP petition.
“The DEA hopes that FDA will implement suitable measures, such as labeling revisions, to help mitigate the adverse impact on the public health resulting from abuse of these products,” wrote Joseph Rannazzisi, deputy assistant administrator of the DEA’s Office of Diversion Control.
The FDA has held public hearings on the PROP petition, but has yet to make a decision.
“If additional improvements could make the labels more effective, it’s important we explore them,” FDA commissioner Hamburg said in a speech this month at a drug abuse summit.