Law and Economics Commons^™

Tip Of The Iceberg Ii: How The Intended-Uses Principle Produces Medical Knowledge And Protects Liberty, Christopher Robertson

Faculty Scholarship

In recent years, the Food and Drug Administration’s pre-market approval process has come under increasing scrutiny as an infringement on liberty and a regulation of speech. In the first part of this symposium contribution, we offer a case study of Seroquel XR, showing how the FDA’s premarket approval process – and the restrictions on “off-label” promotion in particular – caused the drug company to produce and disseminate knowledge about safety and efficacy for new uses. The law successfully resolved the collective action problem of producing knowledge, even while the law protected the liberty of individual doctors and patients to use …