Cornell Law Review Volume 93 Issue 5

Drug Review “Behind the Curtain”: A Response to Professor Struve

The architecture of accident compensation does not mesh well with the architecture of regulatory product approval. Accident compensation, which occurs through public jury trials, is overtly adversarial and virtually transparent. In contrast, regulatory product approval, which occurs through specific negotiation between the product sponsor and the regulatory body, is cooperative and consciously opaque. Indeed, the content of regulatory negotiations remains hidden behind the curtain, shrouded in confidentiality rationales. Consequently, giving regulators a potentially determinative say in tort suits is highly problematic.


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