Pharmaceutical product hops are anticompetitive maneuvers that often represent a last-ditch effort by brand manufacturers to preserve market share in the face of generic competition. An integral part of product life cycle management strategies, product hops may offer marginal benefits to patients but can substantially increase costs to payers and patients alike. Yet industry advocates maintain that this is essential follow-on research and development, resulting in the development of novel products that would otherwise never reach the market.
Is there a middle ground between these two diametrically opposed views? Might certain product hops be considered beneficial, perhaps if they furthered important public health interests? Sometimes product hops arise due to safety concerns raised by FDA or pressure from other public health agencies. For instance, a push from Congress and the EPA to remove chlorofluorocarbons from all consumer and industrial products resulted in a switch from chlorofluorocarbon to hydrofluoroalkane propellants in respiratory inhalers. In another instance, concerns about the opioid crisis fueled the development of abuse-deterrent formulations of opioids as part of a public health response to the crisis. Despite the public health motivations driving each scenario, I find that some public benefit may have been achieved, but at substantial expense to both payers and patients.
I explore the potential benefits of a “public health product hop” in more detail using the recent push to approve over-the-counter versions of intranasal naloxone as a case study. I develop a framework for rewarding product hops that provide a meaningful and quantifiable public health benefit. In these instances, I argue for time-limited patent incentives that more equitably reward manufacturers for advancing important public health-goals while ending regulatory incentives for purely profit-driven product hops.
Sinha, Michael S., Public Health Product Hops. American University Law Review, Vol. 73, 2023, Saint Louis U. Legal Studies Research Paper No. 2023-03.