Doctors Petition FDA to Act on Opioid Painkillers

In response to growing opioid pain prescribing practice abuse, a group of doctors has petitioned the U.S. Food & Drug Administration (FDA) to take action on the powerful and powerfully addictive painkillers. Opioids are highly potent drugs approved for moderate to severe persistent pain that requires treatment for an extended period.

A total of 37 physicians, researchers, and public health officials, many part of the reform group Physicians for Responsible Opioid Prescribing, urged the agency to change labeling for narcotic painkillers, said MedPageToday. If approved, drug companies would face greater challenges in marketing opioid drugs for chronic, noncancer pain. Most of the group, noted MedPageToday, are from other institutions, such as the New York City Health Commissioner; the Cleveland Clinic; the Mayo Clinic; universities; and the watchdog group, Public Citizen.

MedPageToday noted that physician prescribing practices are a contributing factor to the growing opioid epidemic in America. “By implementing the label changes proposed in this petition, FDA has an opportunity to reduce harm caused to chronic pain patients as well as societal harm caused by diversion of prescribed opioids,” the petition states.

As we’ve written, opioids are associated with serious risks of overuse, abuse, misuse and death and the numbers continue to rise. According to the Centers for Disease Control and Prevention (CDC), 14,800 Americans died from overdoses involving opioids in 2008; 15,597 deaths were reported in 2009, a nearly four-fold increase from 1999.

FDA spokesperson, Morgan Liscinsky, said the agency will review the petition and respond to Public Citizen, said MedPageToday.

Public Citizen said labels are, for the most part, too general, indicating that opioids are approved for moderate to severe pain. There are no limitations on how long patients should take the drugs, said MedPageToday. The petition seeks to remove the word “moderate,” to add information indicating a maximum limit equivalent to 100 mg daily of morphine, and for treatment term to be limited to 90 days for noncancer pain. Drug makers would be banned from promoting the medications for off-label uses.

Many doctors falsely believe opioids are safe and efficacious for long-term, noncancer pain. “In the absence of long-term studies demonstrating safety and effectiveness, we need limits on what drug companies can claim about opioids,” Ed Covington, MD, director of the Neurological Center for Pain at the Cleveland Clinic, said in a statement. Lewis Nelson, MD, an emergency physician and medical toxicologist at NYU Langone Medical Center, feels physicians are mistaken in assuming current on-label opioid use is based on good scientific data. “It’s time to close the loophole on opioid labels,” he said, wrote MedPageToday. Covington was one of the petition signers.

Public Citizen’s Wolfe, said the FDA could grant the labeling changes or convene an advisory panel hearing. “They can’t just write this off,” he said. If the agency does not take action in a reasonable amount of time, Public Citizen could sue the agency and force a response, Wolfe said, according to MedPageToday.

In April 2011, the Obama Administration endorsed a mandatory training program on responsible opioid prescribing practices as part of its comprehensive plan to address the epidemic of prescription drug abuse. The program would require legislative changes being pursued by the Administration.

Recently, the FDA released plans to reduce opioid pain killer abuse and misuse, focusing on prescribers and patients. The agency approved a Risk Evaluation and Mitigation Strategy (REMS) for both extended-release (ER) and long-acting (LA) opioids. The REMS measure is part of the federal initiative and introduces new safety measures meant to reduce risks and improve the safe use of ER/LA opioids, while also ensuring access to these medications when needed for patients who are in pain.