The American Medical Association Opposes Changes for Opioid Labeling



I recently wrote about a citizen’s petition called Physicians for Responsible Opioid Prescribing (PROP) which was sent to the Food and Drug Administration (FDA). The petition urged the FDA to relabel opioids and change guidelines which would only allow patients with severe pain to receive strong prescription drugs.  They also asked that the length of prescriptions be reduced to 90 days.  This would require patients to return to their doctors sooner than they currently have to.

On April 9th, the American Medical Association (AMA), composed of many doctors, sent a letter to the FDA urging them to deny the requests from the citizen petition.  James Madara, the Executive Vice President and CEO of AMA, signed the petition.  He stated that “the treatment of pain cannot be fit into a one-size-fits-all approach.”  The point the AMA is most worried about is “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 persons ‘severe’.”

The AMA is also opposed to the 90 day prescription idea because it could “effectively eliminate the use of opioids for non-cancer pain: “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,” said Madara.  Basically the AMA is worried that physicians will become scared of criminal liabilities if a patient gets addicted or overdoses.

The FDA has not made a decision as of yet.  They continue to hold hearings in order to come to a decision. The FDA commissioner Margaret Hamburg stated this past month, “If additional improvements could make the labels more effective, it’s important we explore them.”  The FDA is being urged to make some labeling changes for opioid prescriptions whether they do everything PROP is asking or not.

The PROP petition might be receiving opposition from doctors, but they have the support of the Drug Enforcement Agency.




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