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Innovation and Entrepreneurship Research

Unpacking the Effects of Adverse Regulatory Events: Evidence from Pharmaceutical Relabeling

Higgins, Matthew John; Yan, Xin; Chatterjee, Chirantan (2021). Unpacking the Effects of Adverse Regulatory Events: Evidence from Pharmaceutical Relabeling Research Policy, 50 (1).

We provide causal evidence that regulation induced product shocks significantly impact aggregate demand and firm performance in pharmaceutical markets. Event study results suggest an average loss between $569 million and $882 million. Affected products lose, on average, $186 million over their remaining effective patent life. This leaves a loss of between $383 million and $696 million attributable to declines in future innovation. Our findings complement research that shows drugs receiving expedited review are more likely to suffer from regulation induced product shocks. Thus, it appears we may be trading off quicker access to drugs today for less innovation tomorrow. Results remain robust to variation across types of relabeling, market sizes, and levels of competition.

External Link (DOI)

Also published as: NBER Working Paper 24957