Ohio State experts to review FDA regulations on prescription opioids

A team of experts from Ohio State University has been contracted through Brillient Corporation to conduct an independent review of regulatory actions and Food and Drug Administration decisions regarding currently approved opioid drugs.

The review, due for completion in January 2023, will also examine how to modify the agency’s approach to support the appropriate use of opioid painkillers in a broader public health context, said Patricia Zettler, associate professor at Moritz College. of Law at Ohio State, which is the subject leader for the team exam.

“The focus of our review is on the future,” 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?”

In the United States, an average of 44 people died of prescription painkiller overdoses every day in 2020, accounting for nearly 18% of all opioid overdose deaths that year, according to the Centers for Disease Control and Prevention. The more than 16,000 overdose deaths in 2020 represented a 16% single-year increase in prescription opioid-related deaths.

A 2017 National Academies of Sciences, Engineering, and Medicine (NASEM) National Strategies for Addressing the Opioid Epidemic report recommended that the FDA seek this external review. The NASEM report, which was commissioned by the FDA, generally recommended that the FDA use a comprehensive approach to integrating public health considerations into the regulatory framework for prescription opioids, including consideration of benefits and risks for patients, households and society, as well as the integration of these considerations. considerations at the clinical development stage.

“One of the really difficult things is that these are not products without benefits,” Zettler said. “Prescription opioids have significant benefits for many patients in many different circumstances. It is therefore necessary to determine how to best maximize these benefits while minimizing the truly 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 involved, said Micah Berman, a team member at review, associate professor at the College of Public Health and Moritz. College of Law. Zettler and Berman both worked at the FDA in the past, and Zettler was a consultant to the NASEM committee that published the 2017 report.

“We have the interdisciplinary skills to look at the entire process, from clinical trial to design to some of the post-marketing issues, but also to look at issues of legal authority and how the FDA might want to reconsider the standards it uses for approvals or any new authority it may need,” Berman said. that it has come to, and the broader lessons that can be learned from the FDA’s past experience in regulating opioids – and to address these issues from the research side, the clinical side and the legal side all at a time.

Joining Zettler and Berman for the review are Ohio State scholars Kathy Lancaster, associate professor of epidemiology at the College of Public Health; Macarius Donneyong, assistant professor of outcomes and translational sciences at the College of Pharmacy and College of Public Health; and Marty Fried, clinical assistant professor of internal medicine at the College of Medicine.

In a recent blog post, FDA Commissioner Robert Califf outlined the upcoming review.

“While previous FDA strategies focused largely on opioid use and overdose, the evolving nature of the overdose crisis calls for both a new approach and honest reflection on what the FDA can do differently to the future. … We initiated this review with the goal of understanding what revisions are needed to support the appropriate use of opioid pain relievers. Our “lessons learned” will actively inform our future approach,” he wrote.

The opioid crisis was determined in 2017 as 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 – contribute enormously to the problem of abuse and death by overdose.

For the purposes of this review, the focus will continue to be on regulatory activities related to existing prescription opioid drugs, as well as new pain management products that will be submitted for approval in the future.

“It’s commendable that the government is seeking outside feedback on its approach, especially to such a large and complicated issue,” Zettler said. “While there likely isn’t a one-size-fits-all solution, we look forward to using our expertise to help serve public health and help inform agency regulatory decisions.”