Law Commons^™

Cost-Based California Effects, Jens Frankenreiter

Scholarship@WashULaw

The “California Effect” is a recurring trope in discussions about regulatory interdependence. This effect predicts that businesses active in multiple jurisdictions sometimes adopt the strictest standards that they face in any jurisdiction globally, even if the law does not require global compliance. There is a substantial literature that assumes the existence of California Effects both at the interstate level in the United States and the international level. However, empirical evidence documenting their existence and strength is scarce. This paper investigates the existence of California Effects in data privacy law, a field in which these effects have been said to be …

The Evolving Apa And The Originalist Challenge, Ronald M. Levin

Scholarship@WashULaw

This article, written for a symposium marking the seventy-fifth anniversary of the Administrative Procedure Act (APA), discusses the manifold ways in which courts have creatively interpreted the APA’s provisions on rulemaking, adjudication, and judicial review. Many of these interpretations seem to be barely, if at all, consistent with the intentions of the Act’s drafters and with standard principles of statutory construction. They can, however, be defended as pragmatic judicial efforts to keep up with the evolving needs of the regulatory state, especially in light of Congress’s persistent failure to take charge of updating the Act on its own. At this …

Reforming Reimbursement For The Us Food And Drug Administration’S Accelerated Approval Program To Support State Medicaid Programs, Rachel Sachs, Julie M. Donohue, Stacie B. Dusetzina

Scholarship@WashULaw

Importance The US Food and Drug Administration (FDA) has an accelerated approval program that has become the subject of scholarly attention and criticism, not only for the FDA’s oversight of the program but also for its implications for payers.

Observations State Medicaid programs’ legal obligations to provide reimbursement for accelerated approval products have created fiscal challenges for Medicaid that have been exacerbated by industry’s changing use of the accelerated approval program over time. Although strategies for accelerated approval reforms have been proposed, most focus on reforming the FDA’s accelerated approval pathway and product regulation without taking into account the implications …