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# Gottlieb Pledges Action on Opioid Crisis
- URL: https://www.fdaweb.com/gottlieb-pledges-action-on-opioid-crisis/
- Published: 2017-04-06T12:00:00.000Z
- Updated: 2026-09-14T22:16:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138393

When FDA commissioner-nominee **Scott Gottlieb** is confirmed by the Senate, his “highest immediate priority” will be to assess whether the agency has adequate authorities and resources to address the U.S. opioid crisis. “I think this is a public health emergency on the order of Ebola and Zika, and I think we need to treat this as a public health crisis that requires dramatic action,” he told Senate lawmakers during his 4/5 confirmation ([see earlier story](https://www.fdaweb.com/gottlieb-criticized-on-industry-ties-at-nomination-hearing/)).

Asked to explain how the crisis has worsened in recent years, Gottleib said that for a “long period of time we did not fully recognize the scope of this evolving problem, and our actions to try and address it were too incremental in nature. And I don't say this to try and pass judgment on people who preceded me at FDA. I was at FDA for part of that time as well.” He said the agency and the health community did not fully recognize the scope of the “true addictive nature of these products. I think clinical medicine and physicians... are partly responsible for that.”

Unfortunately, the opioid crisis has spiraled out of control to the extent that it is beyond FDA’s capacity to address it by itself, Gottlieb acknowledged to the senators. “This is a public health challenge that will need to be addressed through the full gamut of our public health resources,” he said. “That does not mean that FDA doesn’t have an important role to play, but I will say, from the standpoint of FDA, I think in order to address it now the types of actions we are going to need to take are going to be far more dramatic perhaps than the types of actions we would have needed to take if we had done more 10 years ago to get ahead of this... (W)e now have the problem that people move to the lowest cost alternatives, and so it is no longer just opioids, and people are moving to heroin.”

Gottlieb said that it will take an “all of the above approach,”... and “there are a number of things we can do. I feel I have a bipartisan mandate through my discussions with this committee to try to push the agency to look harder at what the right framework should be. So to give you some examples, FDA does take on as part of its review process the mandate for looking at the potential for abuse and diversion as a component of the approval process. I think we need to ask hard questions on whether or not the agency has the adequate authorities, resources and policy framework for making sure it is done appropriately.”

Additionally, Gottlieb said the agency will need to “look at opioid drugs in the context of medical devices that could provide alternatives. The safety and benefit of a systemic opioid drug might look a lot different when it is juxtaposed against a device alternative that is delivering localized therapy. I think we might need to look at a different framework. Congress has given FDA some authority to look at drugs and devices in conjunction. We have done that with the oncology division.”

  
FDA also has to create generic standards for drugs that have abuse deterrents, Gottlieb continued, “so we feel more confident clearing the mark that the older drugs that don’t have abuse deterrent feature. So we need good guidelines for how we are going to genericize those drugs so we are not just forcing people onto higher cost drugs when we take the older generic drugs off the market. I think we need to do all these things, and we need to look at alternatives to opioids, and do we have the framework and guidance in place to accelerate the development of non-opioid alternatives for treatment of pain. I think we need to push harder on all these things and it might be the case that when we look at these questions in a hard way, I might have to come back to Congress, if confirmed, and have another conversation with all of you about how to make all of these things happen.”