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The Statutory Case Against Off-Label Promotion, Nathan Cortez
The Statutory Case Against Off-Label Promotion, Nathan Cortez
Faculty Journal Articles and Book Chapters
The Federal Food, Drug, and Cosmetic Act (FDCA) does not expressly prohibit companies from marketing or promoting drugs for unapproved, off-label uses. The FDA itself acknowledges that off-label promotion is not a prohibited act under the statute, or an element of any such act. Instead, the FDA uses off-label promotion as evidence of other statutory violations. This Article engages in perhaps the most thorough statutory construction analysis of the FDCA on this question, finding that the statute does support the FDA's functional ban on off-label promotion. Using various tools of construction, I find that several sections of the FDCA assume …
Much Ado About The Tpp’S Effect On Pharmaceuticals, Emily Michiko Morris
Much Ado About The Tpp’S Effect On Pharmaceuticals, Emily Michiko Morris
SMU Science and Technology Law Review
No abstract provided.