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Full-Text Articles in Food and Drug Law
Can Speech By Fda-Regulated Firms Ever Be Noncommercial?, Nathan Cortez
Can Speech By Fda-Regulated Firms Ever Be Noncommercial?, Nathan Cortez
Faculty Journal Articles and Book Chapters
This Article considers whether speech by pharmaceutical, medical device, and other FDA-regulated companies can ever be noncommercial and thus subject to heightened protection under the First Amendment. Since the U.S. Supreme Court first recognized a right to commercial speech in 1976, there have been 24 published federal judicial opinions in which an FDA-regulated firm has argued that its speech was protected. Courts have categorized the speech as commercial in all but two cases, neither of which involved FDA rules or enforcement.
I examine the tests and factors courts claim they use when making this threshold distinction, then identify the various …
The Food And Drug Administration's Evolving Regulation Of Press Releases: Limits And Challenges, William W. Vodra, Nathan Cortez, David E. Korn
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. …