AMA Opposes Painkiller Labeling Changes

AMA Opposes Painkiller Labeling Changes

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.  

AMA Logo for websiteThe 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.

Authored by: Pat Anson, Editor

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Mary Jo Cordova

The relief that is given with this medication far out weighs the risk of suicide the medical industry will have on their hands! Chronic severe debilitating pain will drive suffers to take their medical needs to the street. This will only further exacerbate not only legal ramifications, of a persons life , but will lead a person to be more suicidal because of the lack of relief from this chronic debilitating Disease! I want the FDA to spend a week in my shoes in order to fully understand the needs of its patients!


I agree with you but I would only add the “Please” is goin to fall on deaf ears with some of these people (as they do not seem to care). They are the ones who tell Us, and the Vets coming back from War they have to live in pain with only 200 mg or Morphine (or equiv.) per day MAX !

Janice Reynolds RN, BC, OCN, CHPN

Thank you for addressing the AMA letter. Dr. Kolondy and others in PROP are becoming very vicious in their efforts to get their agenda passed. They completely disregard the many physicians and nurses who support PROMPT. While the AMA may not have included their names all are thrill with the AMA’s courageous decision to reply to a group whose demands are not evidenced based.

We cant let Andrew Kolodny dictate what he thinks the FDA should do about the relabeling of opioid medications after all he is a Psychiatrist not a Pain Specialist. All he sees is the damage done by people who abuse opiates and its his job to detox these people.

TUESDAY, April 16 , In an effort to help curb the epidemic of prescription painkiller abuse, the U.S. Food and Drug Administration said it is approving new labeling for a reformulated version of OxyContin that its maker claims will be harder to abuse.The agency also noted that the original form of the powerful painkiller OxyContin has been withdrawn from the market because it is easier to abuse than the newer formulation.
“Accordingly, the agency will not accept or approve any abbreviated new drug applications (generics) that rely upon the original formula of the once easy to abuse OxyContin.

Also Opana ER has been reformulated making it close to impossible crush and abuse. As a result the use of heroin is back on the rise, its cheap ,easy to obtain and filthy. This street drug Heroin can cause all kinds of diseases from hepatitis to other health problems like HIV and AIDS from sharing needles. This is where the problems lay not with opioid medications made to help people with chronic pain live a somewhat normal life. When one with chronic pain is titrated up to a level of relief they can return to work. Please don’t take away ones right to live as pain free as possible. Its a doctors obligation to work with those that suffer from chronic pain and a pain patients obligation to follow their doctors orders and not share their medications with friends and lock up their medications at all times. Its a privilege to have ones chronic pain under control.

Mark S. Barletta