Law Commons^™

Regulation By Database, Nathan Cortez

Faculty Journal Articles and Book Chapters

The federal government currently publishes 195,245 searchable databases online, a number of which include information about private parties that is negative or unflattering in some way. Federal agencies increasingly publish adverse data not just to inform the public or promote transparency, but to pursue regulatory ends ⎯ to change the underlying behavior being reported. Such "regulation by database" has become a preferred method of regulation in recent years, despite scant attention from policymakers, courts, or scholars on its appropriate uses and safeguards.

This Article, then, evaluates the aspirations and burdens of regulation by database. Based on case studies of six …

Policymaking By Proposal: How Agencies Are Transforming Industry Investment Long Before Rules Can Be Tested In Court, James W. Coleman

Faculty Journal Articles and Book Chapters

The conventional wisdom is that an executive agency’s scope of action and power depends on how easy it is to reverse agency decisions in court. If non-deferential judges provide industry with prompt review of agency decisions, the agency’s power is limited. And if courts are unlikely to second-guess the agency’s interpretations, then private actors have little choice but to comply. But in recent years, agencies have begun to rely on a new weapon in this struggle with courts and industry — the power of proposed rules to achieve regulatory outcomes. When regulations will affect long-term capital investments, companies must set …

The Food And Drug Administration's Evolving Regulation Of Press Releases: Limits And Challenges, William W. Vodra, Nathan Cortez, David E. Korn

Faculty Journal Articles and Book Chapters

The Food and Drug Administration (FDA) has developed an informal framework for regulating press releases by drug and medical device companies. FDA asserted jurisdiction over press releases based on its authority over labeling and advertising, and over the past 20 years, the agency has both broadened and scaled back its claims to authority over press statements.

Despite a somewhat predictable framework for anticipating how FDA regulates press materials, the agency's approach appears to be in flux. FDA will not tolerate false or misleading statements in press materials, but there are legal and practical limits to its regulation in this area. …