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Full-Text Articles in Law
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 …
Policymaking By Proposal: How Agencies Are Transforming Industry Investment Long Before Rules Can Be Tested In Court, James W. Coleman
Policymaking By Proposal: How Agencies Are Transforming Industry Investment Long Before Rules Can Be Tested In Court, James W. Coleman
Faculty Journal Articles and Book Chapters
The conventional wisdom is that an executive agency’s scope of action and power depends on how easy it is to reverse agency decisions in court. If non-deferential judges provide industry with prompt review of agency decisions, the agency’s power is limited. And if courts are unlikely to second-guess the agency’s interpretations, then private actors have little choice but to comply. But in recent years, agencies have begun to rely on a new weapon in this struggle with courts and industry — the power of proposed rules to achieve regulatory outcomes. When regulations will affect long-term capital investments, companies must set …
Conceptualizing Cryptolaw, Carla L. Reyes
Conceptualizing Cryptolaw, Carla L. Reyes
Faculty Journal Articles and Book Chapters
Sweden transfers its real property recording system to the blockchain, a software protocol that enables public, cryptographically secure transaction verification without reliance upon a trusted third party. Dubai plans to issue blockchain-based government documents. The United States Department of Health and Human Services investigates blockchain-based systems for managing health data. Illinois explores blockchain-based applications for use in the Illinois government. News of governments and public-private partnerships developing blockchain-based legal applications increasingly splash across the headlines; however the law-makers using blockchain and other Distributed Ledger Technology (DLT) systems to implement legal processes do not systematically consider the broader implications of their …