Open Access. Powered by Scholars. Published by Universities.®
- Publication
- Publication Type
Articles 1 - 7 of 7
Full-Text Articles in Law
Suggestions For State Laws On Biosimilar Substitution, Gary M. Fox
Suggestions For State Laws On Biosimilar Substitution, Gary M. Fox
Michigan Telecommunications & Technology Law Review
Biologic drugs offer major advancements over small-molecule drugs when it comes to treating serious diseases. Biosimilars, which mimic innovative biologic drugs, have the potential to further revolutionize the practice of medicine. States now have decades of experience regulating the substitution of generic, small-molecule drugs for their brand-name equivalents. But the complexities of biologic drugs and biosimilars force states to confront novel scientific and legal issues. Many states have begun tackling those issues by passing laws that regulate when pharmacists may substitute biosimilars for their corresponding biologic drugs. Other states have yet to do so. This Note surveys five provisions common …
Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams
Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams
Michigan Law Review
The FDA’s regulatory framework for pharmaceuticals uses a “floor/ceiling” model: administrative rules set a “floor” of minimum safety, while state tort liability sets a “ceiling” of maximum protection. This model emphasizes premarket scrutiny but largely relies on the state common law “ceiling” to police the postapproval drug market. As the Supreme Court increasingly holds state tort law preempted by federal administrative standards, the FDA’s framework becomes increasingly imbalanced. In the face of a historic prescription medication overdose crisis, the Opioid Epidemic, this imbalance allows the pharmaceutical industry to avoid internalizing the public health costs of their opioid products. This Note …
Artificial Intelligence In Health Care: Applications And Legal Implications, W. Nicholson Price Ii
Artificial Intelligence In Health Care: Applications And Legal Implications, W. Nicholson Price Ii
Articles
Artificial intelligence (AI) is rapidly moving to change the healthcare system. Driven by the juxtaposition of big data and powerful machine learning techniques—terms I will explain momentarily—innovators have begun to develop tools to improve the process of clinical care, to advance medical research, and to improve efficiency. These tools rely on algorithms, programs created from healthcare data that can make predictions or recommendations. However, the algorithms themselves are often too complex for their reasoning to be understood or even stated explicitly. Such algorithms may be best described as “black-box.” This article briefly describes the concept of AI in medicine, including …
The Oversimplification Of Deregulation: A Case Study On Clinical Decision Support Software, Deeva V. Shah
The Oversimplification Of Deregulation: A Case Study On Clinical Decision Support Software, Deeva V. Shah
Michigan Telecommunications & Technology Law Review
Until the December 2016 passage of the Cures Act, the FDA had regulatory power over clinical decision support (CDS) software; however, the Act removed a large group of CDS software from the FDA’s statutory authority. Congressional intent was to increase innovation by removing regulatory blockades—such as device testing and certification—from the FDA’s purview. This note argues that the enactment of this specific provision of the Act will instead stymie innovation and overlook the unfortunate safety consequences inherent in its deregulation. CDS software is a burgeoning field ripe for innovation; however, rapid innovation can often lead to a slew of mistakes—mistakes …
Off-Label Promotion Reform: A Legislative Proposal Addressing Vulnerable Patient Drug Access And Limiting Inappropriate Pharmaceutical Marketing, Tim Mackey, Bryan A. Liang
Off-Label Promotion Reform: A Legislative Proposal Addressing Vulnerable Patient Drug Access And Limiting Inappropriate Pharmaceutical Marketing, Tim Mackey, Bryan A. Liang
University of Michigan Journal of Law Reform
Off-label promotion occurs when pharmaceutical manufacturers engage in promotion of unapproved or "off-label" uses of their drugs. These off label uses may lack adequate clinical data to substantiate marketing claims, have led to corporate investigations and penalties, and can endanger public health. However there is adequate evidence to suggest that off-label uses are entirely appropriate for some vulnerable patient populations, and that physicians have accepted such uses as standard. Historically, U.S. law has prohibited direct off-label promotion to physicians and patients. However, failed government guidance, industry-based litigation, and the diminished capacity of regulators to police illegal practices have had dire …
The (Legal) Pains Of Vioxx: Why Product Liability Can Make Products More Dangerous, Omri Ben-Shahar
The (Legal) Pains Of Vioxx: Why Product Liability Can Make Products More Dangerous, Omri Ben-Shahar
Articles
Comparing the experience of Vioxx and Celebrex leads Omri Ben-Shahar to think that stiff product liability has the perverse effect of inducing manufacturers of defective products to leave these products on the market, rather than withdraw them.
Police Initiated Emergency Psychiatric Detention In Michigan, Mark F. Mehlman
Police Initiated Emergency Psychiatric Detention In Michigan, Mark F. Mehlman
University of Michigan Journal of Law Reform
While performing his duties a police officer may frequently be confronted with the behavior of an individual which threatens or has resulted in self-inflicted injury, or which poses an imminent threat to the safety of others. Under such circumstances an officer may determine that criminal arrest is inappropriate but that some form of restraint is necessary. Michigan has provided an alternative course of action by authorizing temporary emergency psychiatric detention of an individual whom a police officer deems to be "mentally ill and manifesting homicidal or other dangerous tendencies."