On September 21, 2018, the Centers for Disease Control (CDC) issued a publication, “Implementing the CDC Guidelines for Prescribing Opioids for Chronic Pain,” which is an “evidence-based prescribing guideline” on how to interpret the 2016 guidelines.
On August 22, 2018, however, the United States Food and Drug Administration (FDA) announced that it is developing “evidence-based guidelines” for prescribing opioids. In his statement that date, FDA Commissioner Scott Gottlieb announced that the FDA 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 the work with NASEM 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.”
Around the same time as the CDC’s release of the new publication, the FDA also issued a document that revised and renamed its 2012 Risk Evaluation and Mitigation Strategy (REMS) for long-term, extended-release opioids to include immediate-release, short-term opioid prescriptions, Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain.” This new blueprint requires drug companies to provide grants to continuing medical education programs to train health care providers who dispense immediate-release opioids in outpatient settings but does not yet require providers to take the training.
With this ping-pong game of guidance and announcements, one may presume that the two agencies are not working together – or even consulting one another – when it comes to prescribing guidelines for opioids. In fact, William Donovan of Orthopedics This Week reviewed a timeline on the FDA website that outlines “significant events” that address opioid misuse and abuse – noting that “the last time FDA documents having done anything jointly with CDC was a July 2015 joint public meeting with other agencies on the use of naloxone, an emergency treatment for overdoses” and before that, there was no mention of interaction with the CDC going back to 2009 (earlier years were not checked).
Donovan also asked the CDC about the guidelines from both agencies, to which the CDC answered, “Collaboration is essential … CDC will actively engage the Department of Health and Human Services (HHS) and relevant Operating Divisions that fall within HHS purview, in addition to any other federal entities deemed relevant, in any Guideline development process.” Interestingly, missing from the CDC response is any indication that the agency is planning to work with the FDA.
Unfortunately for patients and physicians, this tug of war may result in confusion and mayhem until the policy details – and which agency’s guidelines rule the day – are sorted out. Stay tuned, for this is an area that is extraordinarily ripe for continued progress.