Leading with the Trailing Edge: Insulin Availability and Pricing in the U.S.

This project aims to identify insulin products that were removed from the market for reasons other than safety and efficacy concerns and policy solutions to combat this anticompetitive practice. The timing of these market withdrawals will be analyzed with respect to their patent or other exclusivity expirations and the entry of new products by the same company. A similar analysis will be done for three other classes of drugs to determine if the same strategies are used more broadly than for insulin. Lastly, the project will analyze the relevant Food and Drug Administration (FDA) regulatory frameworks to suggest ways to lessen the effects of these anticompetitive behaviors. The project will rely on previous work done by the research team that aggregated and organized FDA Orange Book data on new drug applications, publicly available FDA databases, and medical and legal literature.