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Pharmaceutical product hops extend market monopolies and increase costs, often at the expense of patients. An integral part of product life cycle management strategies by brand manufacturers, product hops often represent a last-ditch effort to preserve market share in the face of generic competition. Yet industry advocates would maintain that this is essential follow-on research and development, producing 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 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. 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 regulatory incentives that more equitably reward manufacturers for advancing important public health-goals while ending incentives for purely profit-driven product hops.


Abstract only.