FDA will require drug makers to research long-term opioid use

The mandate follows a 60 Minutes report on how a label change fueled the opioid crisis

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An update on a story we called "The Label." Last month, Bill Whitaker reported on how the Food and Drug Administration made a fateful decision and approved the use of prescription opioids "around the clock…for an extended period of time." This wording on the label came without any scientific evidence that opioids were safe and effective for more than short-term use. It gave Big Pharma a green light to push opioids to tens of millions of new patients nationwide.

Within days of the broadcast, FDA Commissioner Scott Gottlieb announced the FDA will require that manufacturers of opioids conduct long-term studies to determine the effectiveness of the drugs for chronic pain. The process will take years, but the results, said Dr. Gottlieb, "could lead to regulatory action to limit such use."

As part of our reporting over the past several months, 60 Minutes interviewed two physicians who have participated in the FDA Advisory Committee review process concerning opioids. Dr. Raeford Brown is an anesthesiologist from the University of Kentucky, and Dr. Lewis Nelson is chair of Emergency Medicine at Rutgers. Despite the FDA's labeling allowing opioids to be marketed for "daily, around-the-clock, long-term…treatment," neither physician believe opioids to be safe and effective for long-term use. Dr. Nelson says in the clip below that removing such use from the label would "definitely save lives."

FDA Advisory committee doctors discuss opioid labeling

60 Minutes also spoke to a chronic pain researcher and physician at the University of Michigan, Dr. Daniel Clauw, who was appointed to the US Department of Health and Human Services' Task Force on New Pain Management Best Practices, and has also been retained as an expert witness by the state of Oklahoma in its upcoming opioid litigation. He agrees that opioids are not suitable for long-term use, stating in the clip below that for the "overwhelming majority" of chronic pain patients, the drugs are neither safe nor beneficial. "I believe it was a mistake to approve opioids for chronic pain in the first place," he says. But he's concerned that a sudden change in policy that would restrict opioids could be "catastrophic" for some pain patients already on opioids. "It is a big mess."

Pain doc says FDA must be careful before changing opioid labeling