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Tip Of The Iceberg Ii: How The Intended-Uses Principle Produces Medical Knowledge And Protects Liberty, Christopher Robertson
Tip Of The Iceberg Ii: How The Intended-Uses Principle Produces Medical Knowledge And Protects Liberty, Christopher Robertson
Faculty Scholarship
In recent years, the Food and Drug Administration’s pre-market approval process has come under increasing scrutiny as an infringement on liberty and a regulation of speech. In the first part of this symposium contribution, we offer a case study of Seroquel XR, showing how the FDA’s premarket approval process – and the restrictions on “off-label” promotion in particular – caused the drug company to produce and disseminate knowledge about safety and efficacy for new uses. The law successfully resolved the collective action problem of producing knowledge, even while the law protected the liberty of individual doctors and patients to use …
Speech V. Conduct, Surcharges V. Discounts: Testing The Limits Of The First Amendment And Statutory Construction In The Growing Credit Card Quagmire, Clay Calvert, Rich Shumate, Stephanie Mcneff, Stephenson Waters
Speech V. Conduct, Surcharges V. Discounts: Testing The Limits Of The First Amendment And Statutory Construction In The Growing Credit Card Quagmire, Clay Calvert, Rich Shumate, Stephanie Mcneff, Stephenson Waters
UF Law Faculty Publications
This article examines First Amendment speech concerns and related issues of statutory construction raised by anti-surcharge statutes that prohibit merchants from imposing "surcharges" on credit card purchases, but allow them to offer "discounts" to cash-paying customers. The article uses the split of authority created by the November 2015 opinion of the U.S. Court of Appeals for the Eleventh Circuit in Dana's Railroad Supply v. Florida and the September 2015 decision by the Second Circuit in Expressions Hair Design v. Schneiderman as a timely springboard for analyzing these issues. In September 2016, the U.S. Supreme Court agreed to hear Expressions Hair …
The Tip Of The Iceberg: A First Amendment Right To Promote Drugs Off-Label, Christopher Robertson
The Tip Of The Iceberg: A First Amendment Right To Promote Drugs Off-Label, Christopher Robertson
Faculty Scholarship
Scholars, advocates, and courts have begun to recognize a First Amendment right for the makers of drugs and medical devices to promote their products “off-label,” without proving safety and efficacy of new intended uses. Yet, so far, this debate has occurred in a vacuum of peculiar cases, where convoluted commercial speech doctrine underdetermines the outcome. Juxtaposing these cases against other routine prosecutions of those who peddle unapproved drugs reveals the common legal regime at issue. Review of the seven arguments deployed in the off-label domain finds that, if they were valid, they would undermine the FDA’s entire premarket approval regime. …