Statement by FDA Commissioner Scott Gottlieb, M.D., on new steps to advance the development of evidence-based, indication-specific guidelines to help guide appropriate prescribing of opioid analgesics

As we all work to confront the staggering human and economic toll created by the opioid crisis, we recognize the critical role that health care providers play in addressing this public health priority – both in reducing the rate of new addiction by decreasing unnecessary and/or inappropriate exposure to opioids and ensuring rational prescribing practices, while still providing appropriate treatment to patients who have medical need for these medicines. With millions of Americans misusing and abusing opioids and more than 40 people dying every day from overdoses involving prescription opioids, it’s clear that we need to do everything we can, including working with stakeholders, to get ahead of this crisis.

Many people who become addicted to opioids will first be exposed to these drugs through a lawfully prescribed medication. Unfortunately, the fact remains that there are still too many prescriptions being written for opioids. And too many prescriptions are written for longer durations of use than are appropriate for the medical need being addressed.

Our analyses suggest that the first prescription for many common, acute indications could typically be for many fewer pills – maybe just a day or two of medication rather than a 30-day supply, which is typically prescribed. In some cases, the excess pills that aren’t used by patients may end up being diverted to illicit markets or misused or abused by friends or family members. In other cases, patients who are prescribed more medication than necessary may find themselves at increased risks for misuse, abuse and addiction. This presents a difficult challenge both for the U.S. Food and Drug Administration and for health care providers. We want to reduce the likelihood of misuse and abuse of these drugs and, at the same time, ensure our approaches are properly targeted, evidence-based, and serving the medical needs of patients.

That’s why it’s important that we reexamine how opioid analgesics are being prescribed when deemed an appropriate course of treatment. And it’s why we have to arm health care providers – who are the gatekeepers to prescription opioid analgesics – with the most current and comprehensive guidance on the appropriate management of pain.

One of the ways we believe we can work together with medical professional societies as good stewards of public health is by developing a framework that can assist them in creating evidence-based guidelines on appropriate opioid analgesic prescribing to treat acute pain resulting from specific medical conditions and common surgical procedures for which these drugs are prescribed. Ultimately, our public health goal is to support more rational prescribing practices.

To that end, we’re announcing today that the FDA has awarded a contract to the National Academies of Sciences, Engineering, and Medicine (NASEM) to help advance the development of evidence-based guidelines for appropriate opioid analgesic prescribing for acute pain resulting from specific conditions or procedures. The primary scope of this work is to understand what evidence is needed to ensure that all current and future clinical practice guidelines for opioid analgesic prescribing are sufficient, and what research is needed to generate that evidence in a practical and feasible manner. This contract is independent from the National Academy of Medicine’s new Action Collaborative on Countering the U.S. Opioid Epidemic but our new effort complements the important work that the Academy’s ongoing work seeks to achieve.

We’ve contracted with NASEM to conduct a consensus study and issue a report on its findings. This work will begin with an identification and prioritization of procedures and conditions associated with acute pain for which opioid analgesics are commonly prescribed and where evidence-based clinical practice guidelines would help inform prescribing practices.

As part of this work, NASEM will also scan the landscape of existing opioid analgesic prescribing guidelines, examine how they were developed and any potential gaps in evidence for those guidelines, as well as outline the research needed to generate that evidence. Additionally, NASEM will hold a series of meetings and public workshops to engage a broad range of stakeholders who can contribute expert knowledge on existing guidelines and on emerging evidence or specific policy issues related to the development and availability of opioid analgesic prescribing guidelines based on their specialties.

We acknowledge the work of our colleagues at the U.S. Centers for Disease Control and Prevention (CDC) who have taken an initial step in developing federal guidelines on pain management and the use of opioids which are based on expert opinion. Our work seeks to build on that work by generating evidence-based guidelines where needed. The guidelines we generate would be distinct from this corresponding effort by the CDC, in that our effort would be indication-specific, and would be based on prospectively gathered evidence drawn from evaluations of clinical practice and the treatment of pain. Our work could potentially inform drug labelling. These two efforts are highly complementary and serve adjacent goals.

The FDA also continues important work to educate prescribers on appropriate prescribing practices through the Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS). The REMS requires opioid analgesic manufacturers to make training available to health care providers. In order to comply, this training will use the FDA’s revised Blueprint (FDA “Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain”) that provides information on acute and chronic pain management, safe use of opioid analgesics or other non-opioid or non-drug treatments, as well as material on addiction medicine and opioid use disorders. Once finalized later this year, the REMS will, for the first time, apply to drug companies with approved immediate-release opioid analgesics intended for use in an outpatient setting, in addition to the extended release and long-acting formulations of these drugs that have been subject to a REMS since 2012.

To properly address this crisis, we know it demands an all-of-the-above approach. We’re optimistic that this new effort will result in new, data-driven guidelines from medical professional societies that can be easily accessible to prescribers (and possibly inform product labeling). These evidence-based guidelines can help ensure that opioid analgesic prescribing more closely comports with clinical need. Our hope is that these evidence-based guidelines can help decrease unnecessary and/or inappropriate exposure to opioids and the rate of new addiction, while importantly ensuring that patients with a true clinical need are getting thoughtful, careful, and tailored approaches to treatment.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.