Open Access. Powered by Scholars. Published by Universities.®
Articles 1 - 2 of 2
Full-Text Articles in Law
Fda-Required Tobacco Product Inserts & Onserts – And The First Amendment, Eric N. Lindblom, Micah L. Berman, James F. Thrasher
Fda-Required Tobacco Product Inserts & Onserts – And The First Amendment, Eric N. Lindblom, Micah L. Berman, James F. Thrasher
O'Neill Institute Papers
In 2012, a federal court of appeals struck down an FDA rule requiring graphic health warnings on cigarettes as violating First Amendment commercial speech protections. Tobacco product inserts and onserts can more readily avoid First Amendment constraints while delivering more extensive information to tobacco users, and can work effectively to support and encourage smoking cessation. This paper examines FDA’s authority to require effective inserts and onserts and shows how FDA could design and support them to avoid First Amendment problems. Through this process, the paper offers helpful insights regarding how key Tobacco Control Act provisions can and should be interpreted …
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. …