Are FDA and CDC at War Over Opioid Regulation?

The first public sign of skirmishing between the Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) over opioids was in 2016, when CDC issued a sweeping guideline on prescribing opioids, recommending that many initial prescriptions should be as brief as three days and no longer than seven days.

As we’ve reported in OTW, state legislatures have been carving the CDC guidelines in stone, writing strict laws mandating prescriptions no longer than seven days. One state, New Jersey, made the maximum prescription five days for New Jersey pain sufferers.

Also, the FDA announced on August 22 that it’s developing new “evidence-based guidelines” for prescribing opioids (“FDA’s Draconian Opioid Plan Rebukes CDC,” Orthopedics This Week, September 19, 2018). That announcement seems to be an effort to take back opioid regulation from CDC.

Then, on September 21, CDC issued a 99-page publication, Implementing the CDC Guideline for Prescribing Opioids for Chronic Pain, which is intended to be an “evidence-based prescribing guideline”—note the nearly identical underlined wording—on how to interpret the 2016 guideline.

At about the same time, FDA in September issued a document revising and renaming its 2012 Risk Evaluation and Mitigation Strategy for long-term, extended-release opioids to include immediate-release, short-term opioid prescriptions, under the title, “Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain.” The blueprint newly requires drug companies to provide grants to continuing medical education programs to train health care providers who dispense immediate-release opioids in outpatient settings. It doesn’t yet require care providers to take the training.

What’s missing here? Any indication that the two agencies are working together or consulting one another.

In fact, the FDA website has a detailed “Timeline of Selected FDA Activities and Significant Events Addressing Opioid Misuse and Abuse” from 1911 through August 6, 2018—discussions, meetings, guidelines, regulatory actions, etc. A search reveals 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. Before that? We found no mention of interaction with the CDC going back through 2009 and didn’t check earlier years.

We asked a CDC spokesperson this question: “Is the CDC 2016 guideline now seen as an interim step until such time as an FDA guideline is implemented, or are physicians going to have to deal with two distinctly different guidelines in the future, assuming that the FDA issues one?”

The CDC answer, in part, was, “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.”

Glaringly missing from the above: first, there is no mention of the FDA in particular, which seems like more than a mere oversight, given that FDA has been regulating opioids since 1911; and second, similarly to the absence of any mention of CDC at the FDA website, the CDC comment gives no indication that any collaboration between the two agencies has taken place in the past few years on opioids.

Also, one could reasonably interpret those words to mean that CDC intends to have the lead role in telling physicians how to prescribe opioids in the future.

Where is all this headed? Obviously, toward trouble for both patients and physicians in the short run while both the policy details, and who’s in charge, are sorted out.