Law Commons^™

Regulating Off-Label Promotion — A Critical Test, Christopher Robertson, Aaron S. Kesselheim

Faculty Scholarship

In 2012, the U.S. Court of Appeals for the Second Circuit handed down a landmark decision in the case of pharmaceutical sales representative Alfred Caronia. The Food and Drug Administration (FDA) had approved sodium oxybate (Xyrem) for treating narcolepsy, but Caronia promoted it for a wide range of nonapproved (off-label) indications, including insomnia, Parkinson’s disease, and fibromyalgia. Off-label use is common, especially in specialties such as oncology, in which it may even be considered the standard of care. However, surveys have revealed that supporting evidence is lacking for a majority of off-label uses of medical products.1 The uses Caronia …

Brief Of Amici Curiae Intellectual Property Law Professors, Mark Mckenna, Rebecca Tushnet

Court Briefs

The District Court correctly determined that the challenged speech of Dr. Steven Novella was not commercial speech for purposes of applying the Lanham Act. Appellant’s argument to the contrary conflates “seeking profit” with “commercial speech.”

Truth And Lies In The Workplace: Employer Speech And The First Amendment, Helen Norton

Publications

Employers' lies, misrepresentations, and nondisclosures about workers' legal rights and other working conditions can skew and sometimes even coerce workers' important life decisions as well as frustrate key workplace protections. Federal, state, and local governments have long sought to address these substantial harms by prohibiting employers from misrepresenting workers' rights or other working conditions as well as by requiring employers to disclose truthful information about these matters.

These governmental efforts, however, are now increasingly vulnerable to constitutional attack in light of the recent antiregulatory turn in First Amendment law, in which corporate and other commercial entities seek -- with growing …

Underinclusivity And The First Amendment: The Legislative Right To Nibble At Problems After Williams-Yulee, Clay Calvert

UF Law Faculty Publications

Using the U.S. Supreme Court’s 2015 opinion in Williams-Yulee v. Florida Bar as an analytical springboard, this Article examines the slipperiness — and sometimes fatalness — of the underinclusiveness doctrine in First Amendment free-speech jurisprudence. The doctrine allows lawmakers, at least in some instances, to take incremental, step-by-step measures to address harms caused by speech, rather than requiring an all-out, blanket-coverage approach. Yet, if the legislative tack taken is too small to ameliorate the harm that animates a state’s alleged regulatory interest, it could doom the statute for failing to directly advance it. In brief, the doctrine of underinclusivity requires …