At The Regulatory Review, Katie Cohen L’24, MBE’24 explores the complexities of and continued barriers to increasing access to over-the-counter treatment for opioid overdose.
In response to an escalating and deadly crisis, the FDA recently approved the naloxone nasal spray known as Narcan as over-the-counter treatment for opioid overdose. At The Regulatory Review, Katie Cohen L’24, MBE’24 examines the motivations behind the FDA’s decision and its role in the nation’s broader overdose prevention response.
From The Regulatory Review:
Over 100,000 people died from drug overdoses in 2021. Despite escalation of the opioid public health crisis over the past few years, many communities still struggle to access overdose treatment. The U.S. Food and Drug Administration (FDA) has taken action to confront this issue.
Last month, FDA approved the first over-the-counter naloxone nasal spray, known as Narcan. Narcan reverses the effects of overdose and restores normal respiration, making it the standard treatment for opioid overdose. Narcan’s over-the-counter approval marks the culmination of a hard-fought battle to expand access to overdose treatment, but also presents new challenges for regulators working to control the overdose epidemic.
FDA approved Narcan initially as a prescription drug in 2015, but barriers to accessing the drug impeded its distribution to individuals experiencing an overdose. Although emergency medical personnel and first responders have been equipped with Narcan to prevent opioid overdose deaths, by the time they reach a person having an overdose it is often too late. Family, friends, and bystanders are usually best positioned to save the life of someone at risk of an opioid overdose, but they have struggled to access the drug… .
The Regulatory Review is a daily online publication that provides accessible coverage of regulatory policymaking and enforcement issues across a full range of regulatory topics and from a variety of perspectives.
Launched in 2009 and operating under the guidance of Cary Coglianese, Edward B. Shils Professor of Law and Professor of Political Science, The Review is edited by students at Penn Carey Law. It is part of the overarching teaching, research, and outreach mission of the Penn Program on Regulation (PPR), which draws together more than 60 faculty from across the University of Pennsylvania.