- For Immediate Release:
- Statement From:
Director – Center for Drug Evaluation and Research
Janet Woodcock M.D.
In August 2018, the U.S. Food and Drug Administration contracted the National Academies of Sciences, Engineering, and Medicine (NASEM) to help advance the development of evidence-based guidelines for opioid analgesic prescribing for acute pain resulting from specific conditions or procedures. NASEM was tasked with providing a framework to evaluate current and future opioid prescribing to support a clinical practice guideline and to identify gaps in the evidence where future research is needed. We greatly appreciate all the work done by NASEM to produce the consensus report released today.
We recognize the critical role that health care providers play in addressing the opioid crisis – both in reducing the rate of new addiction by decreasing unnecessary or inappropriate exposure to opioid analgesics, while still providing appropriate pain treatment to patients who have medical needs for these medicines. However, there are still too many prescriptions written for opioid analgesics for durations of use longer than are appropriate for the medical need being addressed. The FDA’s efforts to address the opioid crisis must focus on encouraging “right size” prescribing of opioid pain medication as well as reducing the number of people unnecessarily exposed to opioids, while ensuring appropriate access to address the medical needs of patients experiencing pain severe enough to warrant treatment with opioids.
That’s why it’s important that we re-examine how opioid analgesics are being prescribed and help to ensure that health care providers – who are the gatekeepers to prescription opioid analgesics – are provided 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 is by developing a framework that can assist them in creating and evaluating evidence-based guidelines on appropriate opioid analgesic prescribing to treat acute pain caused by specific medical conditions and common surgical procedures for which these drugs are prescribed.
As part of their work, NASEM examined existing opioid analgesic prescribing guidelines, identified where there were gaps in evidence and outlined the type of research that will be needed to fill these gaps. NASEM also held a series of meetings and public workshops to engage a broad range of stakeholders who contributed expert knowledge on existing guidelines and provided emerging evidence or identified specific policy issues related to the development and availability of opioid analgesic prescribing guidelines based on their specialties.
Moving forward, the FDA will consider the recommendations included in the consensus report as the agency works to implement the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) provision that requires the development of evidence-based opioid analgesic prescribing guidelines for the indication-specific treatment of acute pain for the relevant therapeutic areas where such guidelines do not exist.
The FDA remains committed to addressing this national crisis on all fronts, with a continued focus on decreasing exposure to opioids and preventing new addiction; supporting the treatment of those with opioid use disorder; fostering the development of novel pain treatment therapies; and taking action against those who contribute to the illegal importation and sale of opioid products.
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.