Open Access. Powered by Scholars. Published by Universities.®
Articles 1 - 2 of 2
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 …
Substantiating Big Data In Health Care, Nathan Cortez
Substantiating Big Data In Health Care, Nathan Cortez
Faculty Journal Articles and Book Chapters
Predictive analytics and "big data" are emerging as important new tools for diagnosing and treating patients. But as data collection becomes more pervasive, and as machine learning and analytical methods become more sophisticated, the companies that traffic in health-related big data will face competitive pressures to make more aggressive claims regarding what their programs can predict. Already, patients, practitioners, and payors are inundated with claims that software programs, "apps," and other forms of predictive analytics can help solve some of the health care system's most pressing problems. This article considers the evidence and substantiation that we should require of these …