Digital Commons Network^™

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 …

Process Without Procedure: National Security Letters And First Amendment Rights, Hannah Bloch-Wehba

Faculty Scholarship

Each year, the FBI uses tens of thousands of NSLs to obtain “transactional records” related to telephone calls, emails, text messages, online forums, and other communicative activity. NSLs are usually accompanied by nondisclosure orders that prevent recipients from speaking about or acknowledging the requests. Although over 100,000 NSLs have been issued since 2001, there have been fewer than 10 known judicial challenges.

I argue that the absence of procedural safeguards within the NSL authority has created a de facto regime of automatic compliance with the requests, endangering First Amendment rights in the process. NSLs are explicitly directed at uncovering the …

Liberal, Conservative, And Political: The Supreme Court's Impact On The American Family In The Uber-Partisan Era, Marsha B. Freeman

Faculty Scholarship

No abstract provided.

Testimony Regarding The First Amendment Defense Act (Fada), Katherine M. Franke, Elizabeth A. Sepper, Ariela Gross, Sylvia A. Law, Martin S. Flaherty, Suzanne B. Goldberg, Carol Sanger, J. Stephen Clark, Florens Wagman Roisman, Gregory Magarian, Caroline Mala Corbin, Nomi Stolzenberg, Carlos A. Ball, Aaron Ezra Waldman, Aziza Ahmed, Jennifer A. Drobac, Deborah Widiss, Arthur S. Leonard, Martha M. Ertman

Faculty Scholarship

My testimony today is delivered on behalf of twenty leading legal scholars who have joined me in providing an in depth analysis of the meaning and likely effects of the First Amendment Defense Act (FADA), were it to become law. We feel particularly compelled to provide testimony to this Committee because the first legislative finding set out in FADA declares that: “Leading legal scholars concur that conflicts between same-sex marriage and religious liberty are real and should be addressed through legislation.” As leading legal scholars we must correct this statement: we do not concur that conflicts between same-sex marriage and …

The Early Years Of First Amendment Lochnerism, Jeremy K. Kessler

Faculty Scholarship

From Citizens United to Hobby Lobby, civil libertarian challenges to the regulation of economic activity are increasingly prevalent. Critics of this trend invoke the specter of Lochner v. New York. They suggest that the First Amendment, the Religious Freedom Restoration Act, and other legislative "conscience clauses" are being used to resurrect the economically libertarian substantive due process jurisprudence of the early twentieth century. Yet the worry that aggressive judicial enforcement of the First Amendment might erode democratic regulation of the economy and enhance the economic power of private actors has a long history. As this Article demonstrates, anxieties …

Memorandum On Mississippi House Bill 1523, Katherine M. Franke, Michèle Alexandre, Deborah A. Challener, Judith J. Johnson, Richard Gershon, Elizabeth A. Sepper, Noa Ben-Asher, Daria Roithmayr, Nomi M. Stolzenberg

Faculty Scholarship

As legal scholars with expertise in matters of religious freedom, civil rights, and the interaction between those fields, we offer our opinion on the scope and meaning of Mississippi House Bill 1523, which was signed into law today by Governor Phil Bryant. Specifically, we wish to call attention to language in the law that we believe conflicts with the Establishment Clause of the U.S. Constitution. We share the view of Justice Kennedy when he expressed that “a bare . . . desire to harm a politically unpopular group cannot constitute a legitimate governmental interest,” and would add that neither can …