FDA Admits Making “Many Mistakes” in Opioid Epidemic

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Dr. David Kessler, the FDA commissioner in the 1990s at the time Purdue’s powerful, long-acting opioid OxyContin was first approved, says the FDA never should have allowed the drug and others like it to be broadly marketed for chronic pain patients. The agency erred in radically extending the market for opioids despite the lack of studies on the safety and efficacy for long-term use, he says. The former commissioner says the label on opioid drugs must be changed to limit the ability of drug companies to market opioids. “It needs to be done,” he says.

The change in the FDA’s labeled indication for opioids such as OxyContin to long-term use gave big pharma a green light to push opioids to 10s of millions of new pain patients nationwide. “You have a system of pharmaceutical promotion that changed the way medicine is practiced, and no one, all right, stopped it,” says Kessler, who has been retained by cities and counties suing big pharma for the opioid crisis. The marketing led to an over-prescribing of the dangerous drugs and a river of pills that fueled the deadly epidemic, as companies were allowed to sell more and more pills at higher and higher doses. Kessler speaks to Bill Whitaker for a 60 MINUTES report to be broadcast Sunday, Feb. 24 (7:00-8:00 PM, ET/PT) on the CBS Television Network.

In 2001, after Dr. Kessler left the agency, the FDA officially relabeled the powerful opioid OxyContin to be used for an “extended period of time” by chronic pain suffers. Originally approved based on science that showed it safe and effective only when used “short-term,” the label was changed without adequate scientific study. “We don’t know whether the drugs are safe and effective for chronic use,” Kessler says. “The rigorous kind of scientific research the agency should be relying on is not there.” The right to market for the new indication was ultimately granted to a whole class of opioids.

Dr. Andrew Kolodny, an addiction specialist at Brandeis University who has been an expert witness in litigation against big pharma, including Purdue, has been trying to get the FDA to change the label and limit the marketing of opioids since 2011. He tells Whitaker opioids are essential drugs for pain management at the end of life and for short-term pain needs. “[But] if you’re taking them around the clock…you become tolerant to the pain-relieving effect…you’ll need higher and higher doses,” he says. “The treatment becomes more dangerous, and the risk of death goes up,” says Kolodny.

Asked by Whitaker why the FDA failed to act in this case as the watchdog it was created to be, Kessler partly blamed understaffing in the FDA division that oversaw marketing and promotion.

Dr. Scott Gottlieb, the current FDA commissioner, turned down an interview request, but provided a statement to 60 MINUTES. It reads in part: “Many mistakes were made along the way…While the agency followed the law in approving and regulating opioids, we at the FDA include ourselves among those that should have acted sooner.”

On Sunday’s 60 MINUTES, Whitaker will also report the role drug manufacturers had in the label change – which greatly increased profits – and on the relationship between drug makers and the FDA.