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# FDA Wrongful Label Change ‘Ignited Opioid Crisis’: 60 Minutes
- URL: https://www.fdaweb.com/fda-wrongful-label-change-ignited-opioid-crisis-60-minutes/
- Published: 2019-02-25T12:00:00.000Z
- Updated: 2026-09-15T01:07:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143452

Pharmaceutical Manufacturing Research Services chief executive **Ed Thompson** told CBS’s [*60 Minutes* 2/24](https://www.cbsnews.com/news/opioid-epidemic-did-the-fda-ignite-the-crisis-60-minutes/?ref=fdaweb.com) that FDA ignited the current opioid crisis when in 2001, and pressured by Big Pharma, the agency wrongly approved a label expansion for Purdue Pharma’s Oxycontin to be used for chronic, long-term pain treatment and beyond its original approval for short-term use. The 2001 expanded use decision was made without any new science or data showing that such use was safe and effective, Thompson and other experts told 60 Minutes journalist **Bill Whitaker**.

Thompson said the label change opened the floodgates to increased marketing for opioids, and the rest is history.

In court documents obtained from a West Virginia state lawsuit over Purdue’s alleged deceitful marketing, *60 minutes* uncovered the minutes of secret meetings in 2001 between Purdue Pharma and FDA. They revealed that it was at those secret meetings the agency “bowed to Purdue Pharma's demands to ignore the lack of scientific data, and changed the label to, ‘around the clock…for an extended period of time,’” Whitaker reported.

Purdue told *60 Minutes* that Oxycontin always was approved for long-term use. But an internal document shows the company was excited about the revised labeling. According to *60 Minutes,* the Purdue document said: “The action by the FDA…has created enormous opportunities” to expand the market. The ads from the drug firm “soon extolled the virtues of Oxycontin's effectiveness and sales tripled,” it said.

Former FDA commissioner **David Kessler**, now a consultant to opioid litigants,reviewed documents obtained by *60 Minutes* and said changing the opioid label to long-term use was a mistake. “There are no studies on the safety or efficacy of opioids for long-term use,” he said.

Brandeis professor **Andrew Kolodny**, who is a recognized expert witness in litigation against Big Pharma, did his own research into how FDA approved the expanded opioid use. “We found out that a group of experts and FDA and pharmaceutical companies were having private meetings and at these meetings, changing the rules for how opioids get approved,” he said. At one closed-door meeting, drug makers paid $35,000 a piece to consultants to “sit at a small table with the FDA,” “hobnobbing with the regulators,” *60 Minutes* said. Emails show one participant worrying it might be seen as “pay to play.”

Kolodny noted that the drug companies “had drugs in their pipeline, pain medicines that they wanted approved. And through these meetings, they were able to get those products on the market.” He said the meetings were unethical at best, and should be illegal. The two medical officers who originally approved Oxycontin ended up working for Purdue Pharma not long after leaving FDA. “The culture at FDA continues to be much too cozy with the industry it's supposed to be regulating,” he said.

FDA commissioner **Scott Gottlieb** declined a *60 Minutes* interview request. However, in a statement he said, “the FDA has taken aggressive steps to confront the crisis, but he admitted “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 who should have acted sooner.”

Meanwhile, Big Pharma will face a major test in a few months when the first trial at which a jury could decide whether drug companies are responsible for the ongoing opioid crisis. In Norman, OK, the trial is scheduled to begin 5/28, and judge **Thad Balkman** has agreed to have it televised live every day, “raising the prospect of nationwide coverage of grieving families and embarrassing internal company emails,” [according to the *Washington Post*](https://www.washingtonpost.com/national/oklahoma-could-provide-first-test-of-who-will-pay-for-the-opioid-crisis--and-how-much/2019/02/19/c35ad366-3082-11e9-8ad3-9a5b113ecd3c%5Fstory.html?utm%5Fterm=.b2cbc04e11ee&ref=fdaweb.com). “What happens there is going to set the standard for what happens after it,” said **Abbe R. Gluck**, a Yale Law School professor, who predicted that the outcome in Oklahoma could provide leverage to the victor in the larger federal case to follow in Cleveland.