A team of Ohio State University experts has been awarded a contract through Brillient Corporation to complete an independent review of the Food and Drug Administration’s regulatory actions and decisions on currently approved opioid medications.
The review, due to be completed in January 2023, will also consider how to alter the agency’s approach to support appropriate use of opioid painkillers in an expanded public health context, said Patricia Zettler, associate professor in Ohio State’s Moritz College of Law, who is the subject matter lead for the team review.
“The focus of our review is forward-looking,” Zettler said. “How could the FDA use the authority it has to better serve its public health mission, and what additional legal authorities might be useful to improve opioid regulation?”
An average of 44 people in the United States died each day from prescription opioid painkiller overdoses in 2020, accounting for almost 18% of all opioid overdose deaths that year, according to the Centers for Disease Control and Prevention. The 16,000-plus overdose deaths in 2020 represented a single-year 16% increase in prescription opioid-involved deaths.
A report on national strategies to address the opioid epidemic issued by the National Academies of Science, Engineering and Medicine (NASEM) in 2017 recommended that the FDA seek this external review. The NASEM report, which was requested by the FDA, generally recommended that the FDA use a comprehensive approach for incorporating public health considerations into the regulatory framework for prescription opioids, including accounting for benefits and risks to patients, households and society as well as incorporating such considerations at the clinical development stage.
“One of the really challenging things is that these are not products without benefits,” Zettler said. “Prescription opioids have important benefits for a lot of patients under many different circumstances. So there is a need to figure out how to best maximize those benefits while also minimizing the really serious risks of the products.”
Ohio State is home to a collection of scholars with the right mix of expertise in law, public health, pharmacy and medicine to address the many policy considerations at issue, said review team member Micah Berman, associate professor in the College of Public Health and Moritz College of Law. Both Zettler and Berman have worked at the FDA in the past, and Zettler was a consultant to the NASEM committee that issued the 2017 report.
“We have the interdisciplinary skills to look at the whole process all the way from the clinical trial to design to some of the post-marketing issues, but also to look at questions of legal authority and how the FDA might want to reconsider the standards it uses for approvals or any new authority that it might need,” Berman said. “It’s a pretty broad mandate to look at all of those things – the process the agency used and the decisions that it came to, and the broader lessons that can be gleaned from the FDA’s past experience regulating opioids – and to approach those questions from the research side, the clinical side and the legal side all at the same time.”
Ohio State scholars joining Zettler and Berman for the review are Kathy Lancaster, associate professor of epidemiology in the College of Public Health; Macarius Donneyong, assistant professor of outcomes and translational sciences in the College of Pharmacy and College of Public Health; and Marty Fried, clinical assistant professor of internal medicine in the College of Medicine.
In a recent blog post, FDA Commissioner Robert Califf described the upcoming review.
“While the FDA’s previous strategies have largely focused on opioid use and overdoses, the evolving nature of the overdose crisis calls for both a new approach and honest reflection about what the FDA can do differently moving forward. … We have initiated this review with the intended goal of understanding what revisions are needed to support appropriate use of opioid analgesics. Our ‘lessons learned’ will actively inform our future approach,” he wrote.
The opioid crisis was determined in 2017 to be a public health emergency, and that designation is still in effect, Califf wrote, noting that illicit opioids – particularly heroin, fentanyl and compounds with similar chemical structures – are huge contributors to the problem of misuse and overdose deaths.
For the purposes of this review, the focus will remain on regulatory activities related to existing prescription opioid medications – as well as new pain-management products that will come up for approval in the future.
“It’s laudable for the government to seek external input on its approach, particularly for a problem this large and this complicated,” Zettler said. “Although there isn’t likely to be one solution, we’re looking forward to using our expertise to help serve the public health and help inform the agency’s regulatory decisions.”