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# Trump Mentions FDA Role in Opioid Emergency Declaration
- URL: https://www.fdaweb.com/trump-mentions-fda-role-in-opioid-emergency-declaration/
- Published: 2017-10-26T12:00:00.000Z
- Updated: 2026-09-14T22:58:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139980

FDA was briefly mentioned in president Trump’s 10/26 speech declaring the opioid abuse crisis in the U.S. to be a public health emergency. “The FDA is now requiring drug companies that manufacture prescription opioids to provide more training to prescribers and to help prevent abuse and addiction and has requested that one especially high risk opioid be withdrawn from the market immediately,” the president said (see [transcript](http://www.townandcountrymag.com/society/politics/a13100237/trump-opioid-crisis-speech-transcript/?ref=fdaweb.com)). He presumably was talking about the agency’s recent decision to extend Risk Evaluation and Mitigation Strategy (REMS) requirements that now apply to extended-release/long-acting (ER/LA) opioid formulations to cover immediate-release (IR) formulations as well ([see earlier story](https://www.fdaweb.com/fda-extending-rems-to-ir-opioids/)). Writing in a recent *FDA Voice* blog [post](https://blogs.fda.gov/fdavoice/index.php/2017/09/fda-takes-important-steps-to-stem-the-tide-of-opioid-misuse-and-abuse/?ref=fdaweb.com), commissioner **Scott Gottlieb** said FDA notified 74 manufacturers of IR opioids intended for outpatient use that their drugs will be subject to the more stringent ER/LA REMS requirements, including that training on safe prescribing practices and consideration of non-opioid alternatives be made available to healthcare providers who prescribe IR opioids.

The high-risk opioid being withdrawn from the market is Endo Pharmaceuticals’ Opana ER (oxymorphone hydrochloride), the benefits of which the agency announced in June may no longer outweigh its risks ([see story](https://www.fdaweb.com/fda-wants-opana-er-pulled-from-market/)).

The public health emergency declaration comes on the heels of Gottlieb’s 10/25 [testimony](https://www.fda.gov/NewsEvents/Testimony/ucm582037.htm?ref=fdaweb.com) before the House Energy and Commerce Committee that FDA is focusing on three broad areas to help address the opioid crisis — lowering overall exposure to opioid drugs and, in turn, reducing the number of new cases of addiction; enabling more opportunities for those currently addicted to opioid drugs to seek medication-assisted treatment that can help them recover; and helping expedite the development of progressively more effective abuse deterrent formulations of opioid drugs and non-opioid alternatives for treating pain.

After the president’s announcement, Gottlieb released a [statement](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm582424.htm?ref=fdaweb.com) saying the agency is “committed to taking additional steps under the new declaration of a public health emergency to more forcefully confront this immense national tragedy. This includes taking aggressive steps to prevent new addictions and opioid-related deaths, and help those currently addicted regain control and restore them to their communities.”

Criticizing Trump’s declaration, advocacy group Public Citizen says a proper national strategy on opioids “must include a plan to rein in the corrupt abuses of the pharmaceutical industry, or it likely will fail... Big Pharma hooked millions of Americans on opioids through illegal marketing, greed and undermining safety standards. Now these corporations profiteer on our efforts to end the epidemic, too, by spiking the prices of overdose treatments and manipulating safety standards to block addiction therapy competitors. Local health budgets and services are straining to keep up, in some cases rationing antidotes as a result.”

In his declaration speech, Trump did however vaguely mention that his administration will “be looking at the potential of the federal government bringing major lawsuits against bad actors... We will be bringing some very major lawsuits against people and against companies that are hurting our people. And that will start taking place pretty soon.”

In reaction to the declaration, PhRMA said: “This problem is too complex for any single person or policy to solve alone, which is why we have been working closely with this administration and other health care leaders to expand our efforts... PhRMA also recently announced a new partnership with the National Institutes of Health (NIH) and the National Institute on Drug Abuse (NIDA) to bring the best and brightest researchers from across the industry to develop new addiction and drug overdose treatments, as well as non-opioid alternatives to pain management. And we recently announced the industry’s support for a seven-day script limit on opioids for acute pain as part of a comprehensive set of forward-leaning policy solutions that will be laid out in more detail over the coming weeks.”