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# Gottlieb: FDA Requiring Long-term Studies on Opioids
- URL: https://www.fdaweb.com/gottlieb-fda-requiring-long-term-studies-on-opioids/
- Published: 2019-02-26T12:00:00.000Z
- Updated: 2026-09-15T01:08:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143466

On the heels of a critical CBS [*60 Minutes* report](https://www.cbsnews.com/news/opioid-epidemic-did-the-fda-ignite-the-crisis-60-minutes/?ref=fdaweb.com) that claimed FDA ignited the current opioid crisis, commissioner **Scott Gottlieb** says the agency will require opioid manufacturers to conduct long-term studies to evaluate whether the drugs maintain their effectiveness with chronic use. “This is a critical question,” he said on Twitter. “Depending on what we learn it could lead to regulatory action to limit such use.”

“We are going to impose a mandate on existing products . . . to answer the question that people have been posing for years: whether you have declining efficacy, and whether that declining efficacy can lead to addiction,” Gottlieb said in a *Washington Post* [interview](https://www.washingtonpost.com/national/health-science/fda-takes-fresh-look-at-whether-opioids-are-effective-for-chronic-pain/2019/02/25/227a5fe6-3917-11e9-a06c-3ec8ed509d15%5Fstory.html?utm%5Fterm=.2c1d8c77b138&ref=fdaweb.com).

The *60 Minutes* segment ([see earlier story](https://www.fdaweb.com/fda-wrongful-label-change-ignited-opioid-crisis-60-minutes/)) criticized FDA for being too cozy with Big Pharma, which led to a 2001 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, experts told *60 Minutes*.

Gottlieb’s move to require new studies will be hailed by many as a positive step to get in front of the opioid crisis. *\[Editor’s note and full disclosure: *FDA Webview** [*publicly endorsed*](https://www.fdaweb.com/we-endorse-scott-gottlieb-for-fda-commissioner/) *Gottlieb after his nomination by President Trump, despite concerns raised about his deep industry ties.\]* However, many will also see the move as shifting the blame back onto industry. Such studies will take years to complete, and there are few incentives for opioid makers to expedite their efforts.

At least one critic has already come forward. Brandeis professor and [Physicians for Responsible Opioid Prescribing](http://www.supportprop.org/?ref=fdaweb.com) director **Andrew Kolodny** said FDA already has all the research it needs — and authority under existing law — to tighten restrictions on the use of opioids for chronic pain by changing instructions for how they should be prescribed. “Here we go again,” Kolodny told the *Post*. “That’s exactly what the FDA said to us in 2013\. . . . Five years later, we don’t have the studies and another FDA commissioner says, ‘We’re going to do the studies.’”

Gottlieb also said that the agency is mandating another study to assess whether opioids can cause users to become more sensitive to pain ([hyperalgesia](https://www.ncbi.nlm.nih.gov/pubmed/21412369?ref=fdaweb.com)). Planning for that research by a consortium of companies is further along and it should start soon, he told the *Post*. Gottlieb said those studies were difficult to order because FDA had authority only to require post-market studies of safety, and not effectiveness. The agency acquired the authority to demand post-market effectiveness studies as part of the [Support for Patients and Communities Act,](https://www.congress.gov/bill/115th-congress/house-bill/6?ref=fdaweb.com) which passed in October.