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Full-Text Articles in Law
Regulating Black-Box Medicine, W. Nicholson Price Ii
Regulating Black-Box Medicine, W. Nicholson Price Ii
Michigan Law Review
Data drive modern medicine. And our tools to analyze those data are growing ever more powerful. As health data are collected in greater and greater amounts, sophisticated algorithms based on those data can drive medical innovation, improve the process of care, and increase efficiency. Those algorithms, however, vary widely in quality. Some are accurate and powerful, while others may be riddled with errors or based on faulty science. When an opaque algorithm recommends an insulin dose to a diabetic patient, how do we know that dose is correct? Patients, providers, and insurers face substantial difficulties in identifying high-quality algorithms; they …
Harnessing Private Regulation, Lesley K. Mcallister
Harnessing Private Regulation, Lesley K. Mcallister
Michigan Journal of Environmental & Administrative Law
In private regulation, private actors make, implement, and enforce rules that serve traditional public goals. While private safety standards have a long history, private social and environmental regulation in the forms of self-regulation, sup-ply chain contracting, and voluntary certification and labeling programs have proliferated in the past couple decades. This expansion of private regulation raises the question of how it might be harnessed by public actors to build better regula-tory regimes. This Article tackles this question first by identifying three forms of strong harnessing: public incorporation of private standards, public endorsement of self-regulation, and third-party verification. It then analyzes eight …
Making Method Visible: Improving The Quality Of Science-Based Regulation, Pasky Pascual, Wendy Wagner, Elizabeth Fisher
Making Method Visible: Improving The Quality Of Science-Based Regulation, Pasky Pascual, Wendy Wagner, Elizabeth Fisher
Michigan Journal of Environmental & Administrative Law
Scientific inferences are theories about how the world works that scientists formulate based on their observations. One of the most difficult issues at the intersection of law and science is to determine whether the weight of evidence supports one scientific inference versus other competing interpretations of the observations. In administrative law, this difficulty is exacerbated by the behavior of both the courts and regulatory agencies. Agencies seldom achieve the requisite visibility that explains the analytical methods they use to reach their scientific inferences. Courts—because they appreciate neither the variety of inferential methods nor their epistemic foundations—do not demand this level …
A New Prescription To Balance Secrecy And Disclosure In Drug-Approval Processes, Gerrit M. Beckhaus
A New Prescription To Balance Secrecy And Disclosure In Drug-Approval Processes, Gerrit M. Beckhaus
University of Michigan Journal of Law Reform
To obtain approval to market a drug, a manufacturer must disclose significant amounts of research data to the government agency that oversees the approval process. The data often include information that could help advance scientific progress, and are therefore of great value. But current laws in both the United States and Europe give secrecy great weight. This Article proposes an obligatory sealed-bid auction of the sensitive information based on the experience with similar auctions in mergers and acquisitions, to balance manufacturers' interest in secrecy and the public interest in disclosure.
Rulemaking Vs. Democracy: Judging And Nudging Public Participation That Counts , Cynthia R. Farina, Mary Newhart, Josiah Heidt, Cornell Erulemaking Initiative
Rulemaking Vs. Democracy: Judging And Nudging Public Participation That Counts , Cynthia R. Farina, Mary Newhart, Josiah Heidt, Cornell Erulemaking Initiative
Michigan Journal of Environmental & Administrative Law
This Article considers how open government “magical thinking” around technology has infused efforts to increase public participation in rulemaking. We propose a framework for assessing the value of technology-enabled rulemaking participation and offer specific principles of participation-system design, which are based on conceptual work and practical experience in the Regulation Room project at Cornell University. An underlying assumption of open government enthusiasts is that more public participation will lead to better government policymaking: If we use technology to give people easier opportunities to participate in public policymaking, they will use these opportunities to participate effectively. However, experience thus far with …
Privacy Policies, Terms Of Service, And Ftc Enforcement: Broadening Unfairness Regulation For A New Era, G. S. Hans
Privacy Policies, Terms Of Service, And Ftc Enforcement: Broadening Unfairness Regulation For A New Era, G. S. Hans
Michigan Telecommunications & Technology Law Review
This Note examines website privacy policies in the context of FTC regulation. The relevant portion of Section 5 of the Federal Trade Commission Act, 15 U.S.C. § 45(a), uses the following language to define the scope of the agency's regulatory authority: "Unfair methods of competition in or affecting commerce, and unfair or deceptive acts or practices in or affecting commerce, are hereby declared unlawful." Specifically, this Note analyzes the FTC's power to regulate unfair practices (referred to as the FTC's "unfairness power") granted by Section 5, and also discusses the deception prong of Section 5, which allows the agency to …
Enhancing Public Access To Online Rulemaking Information, Cary Coglianese
Enhancing Public Access To Online Rulemaking Information, Cary Coglianese
Michigan Journal of Environmental & Administrative Law
One of the most significant powers exercised by federal agencies is their power to make rules. Given the importance of agency rulemaking, the process by which agencies develop rules has long been subject to procedural requirements aiming to advance democratic values of openness and public participation. With the advent of the digital age, government agencies have engaged in increasing efforts to make rulemaking information available online as well as to elicit public participation via electronic means of communication. How successful are these efforts? How might they be improved? In this article, I investigate agencies’ efforts to make rulemaking information available …
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 …
It Is Time: Why The Fda Should Start Disclosing Drug Trial Data, Mustafa Ünlü
It Is Time: Why The Fda Should Start Disclosing Drug Trial Data, Mustafa Ünlü
Michigan Telecommunications & Technology Law Review
Although [drug] manufacturers bear the cost of research data generation, it is oftentimes a worthwhile investment that also confers significant commercial advantages. Consequently, they have argued that research data should be considered a trade secret and kept confidential. The FDA's longstanding position has been to accept this proposition. Even when Congress appeared to mandate disclosure or weaken the underlying rationale for secrecy, the FDA has continued to treat research data as confidential. A strong argument against a default posture of confidentiality is that research data disclosure would promote broad public interests by eliminating the societal costs brought about by keeping …
Fcc Jurisdiction Over Isps In Protocol-Specific Bandwidth Throttling, Andrew Gioia
Fcc Jurisdiction Over Isps In Protocol-Specific Bandwidth Throttling, Andrew Gioia
Michigan Telecommunications & Technology Law Review
Over the past decade, the Internet has matured from its dial-up infancy into the nation's dominant communications infrastructure. Such rapid growth and accessibility--while fostering free speech and innovation like nothing before--has nonetheless created complex regulatory and policy questions for both the Federal Communications Commission (FCC) and the cable companies providing the nation's broadband Internet access. For instance, Comcast, one such Internet provider, has recently brought to the fore the question of how, and to what extent, the FCC can ensure an open and accessible Internet through the company's recent actions in selectively targeting and interfering with the connections of certain …
Key Disclosure Issues For Life Sciences Companies: Fda Product Approval, Clinical Test Results, And Government Inspections, William O. Fisher
Key Disclosure Issues For Life Sciences Companies: Fda Product Approval, Clinical Test Results, And Government Inspections, William O. Fisher
Michigan Telecommunications & Technology Law Review
The government, particularly the Food and Drug Administration ("FDA"), heavily regulates the life sciences industry. FDA actions can have an extraordinary influence on the fortunes of biotechnology companies. Timely FDA approval of a drug or medical device can permit a company to exploit an inviting market window. FDA product approval is, in turn, tied to clinical test results which demonstrate "efficacy" and safety. Delayed approval, unfavorable test results, or the denial of an FDA application may ruin a company. Beyond the FDA product approval process and related testing lie FDA inspections and the possibility that the government will investigate charges …