Law Commons^™

Florida East Coast Railway And The Structure Of Administrative Law, Michael P. Healy

Law Faculty Scholarly Articles

A typical Administrative Law course presents the Supreme Court's decision in United States v. Florida East Coast Railway Co. as establishing the rule that statutory text quite close to the magic words, "on the record after opportunity for an agency hearing," is needed to trigger the Administrative Procedure Act's (APA) formal hearing requirements for a rulemaking. Florida East Coast Railway is a prime example of an underrated case because, even though the case is well known, its renown is a consequence only of its black letter rule about rulemaking procedures. Many scholars and practitioners do not appreciate the case for …

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. …