On average, one in twelve people in America have asthma, and ten patients die from asthma every day. A largely manageable disease, asthma nonetheless takes a tremendous toll on patients in the United States. For almost two decades, these patients have seen the cost of asthma medication rise exponentially, even though some of the most commonly prescribed treatments have existed since the mid-twentieth century. Today, one in six asthma patients reports skipping, delaying or foregoing treatment for financial reasons.

This Article presents a case study on a specific product — asthma inhalers — as a lens through which to examine the origins of the asthma medication affordability crisis within the legal infrastructure that governs the regulation and commercialization of pharmaceuticals. This infrastructure straddles FDA and patent law, and a disconnect between these legal frameworks — as well as between the regulators themselves — has repeatedly facilitated regulatory gamesmanship by several manufacturers of asthma medication. These problems are compounded by market strategies through which yet another set of actors — insurers and pharmacy benefit managers — drives up the cost shouldered by American asthma patients. 

Recently, there have been some attempts to curb prices in this area, mainly through state-imposed price caps on asthma medication, as well as some instances of industry self-regulation in the form of caps on inhaler prices. However, these interventions have been uneven and insufficient to address the effects of the affordability crisis. They also leave the root causes of ongoing problems largely untouched.

Against this backdrop, this Article identifies and examines both existing and overlooked pathways to make asthma medication affordable to American patients. It considers remedial approaches (short-term measures aimed at addressing the public health and economic consequences of the crisis) and structural reforms (interventions aimed at eliminating gamesmanship of drug-patent laws, or at implementing contracting practices that promote drug affordability).