Rising overdose deaths: Ohio State experts to review FDA’s opioids plan and provide ‘actionable recommendations’

The US remains stuck in a rapidly growing opioid epidemic, as overdose deaths quintupled over the last two decades to a record number of American deaths last year — more than 107,000.

As part of efforts to slow those rising numbers, and earn his Senate confirmation, FDA commissioner Rob Califf committed to a major review of the agency’s opioid decision-making process, including labeling.

And while Califf said late last month that the FDA had initiated a review of what needs to change to better support the appropriate use of opioids, he announced yesterday in a series of tweets that experts at the Ohio State University “will provide actionable recommendations for FDA both within existing authorities and where additional authorities are needed.”

The review will be conducted by external experts associated with Ohio State University. These subject matter experts are familiar with the FDA, the 2017 recommendations from @theNASEM, and opioid prescribing issues.

— Dr. Robert M. Califf (@DrCaliff_FDA) September 19, 2022

Patricia Zettler, a former associate chief counsel at the FDA who’s now an associate professor of law at the Ohio State University Moritz College of Law, previously consulted on the NASEM report on opioids.

Patricia Zettler

Zettler did not respond to a request for comment by press time, but the NSAEM report began to lay out a path whereby the FDA should consider developing a better way to incorporate individual and societal considerations into its risk-benefit framework for opioid approvals and monitoring moving forward.

In June 2019, the agency also released new draft guidance spelling out how it might compare the effectiveness and safety of new opioids with already approved opioids, but the FDA also noted that while the comparative data “is helpful in applying the benefit risk framework, superiority to other available treatments is not a requirement for approval under FDA’s drug approval authorities.”

But it’s not just about the new approvals and adapting the labels, or even further prescriber education.

The status quo is “a market that is flooded with inexpensive, generic opioids. And, those are the go-to because they are economically priced and accessible for patients and make an economical choice for the treatment of pain in a cost-effective manner. As long as we have this conundrum, we’re not going to be able to shift the needle,” Beatrice Setnik from Altasciences previously said at an opioids-related public hearing at FDA in 2019. “The opioids that are currently marketed are very much in the hands of the payers, because they ultimately will decide what the patients will receive. And that will always be based on an economical choice, rather than for the benefit of society.”

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