Law Commons^™

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 …

Taking Public Access To The Law Seriously: The Problem Of Private Control Over The Availability Of Federal Standards, Nina A. Mendelson

Articles

In the 1930s, Harvard professor Erwin Griswold famously complained about the enormous numbers of New Deal regulations that were obscurely published on individual sheets or in “separate paper pamphlets.” Finding these binding federal rules was difficult, leading to “chaos” and an “intolerable” situation. Congress responded, requiring that agencies publish all rules in the Federal Register and in the Code of Federal Regulations (CFR). Currently, recent federal public laws, the entire U.S. Code, the Federal Register, and the CFR are all freely available online as well as in governmental depository libraries. But with respect to thousands of federal regulations, the clock …

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 …

Private Control Over Access To Public Law: The Perplexing Federal Regulatory Use Of Private Standards, Nina A. Mendelson

Articles

To save resources and build on private expertise, federal agencies have incorporated privately drafted standards into thousands of federal regulations — but only by “reference.” These standards range widely, subsuming safety, benefits, and testing standards. An individual who seeks access to this binding law generally cannot freely read it online or in a governmental depository library, as she can the U.S. Code or the Code of Federal Regulations. Instead, she generally must pay a significant fee to the drafting organization, or else she must travel to Washington, D.C., to the Office of the Federal Register’s reading room. This law, under …

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

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

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

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

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

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

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

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 …

Learning The Value Of Drugs - Is Rofecoxib A Regulatory Success Story?, Rebecca S. Eisenberg

Articles

Controversy over recent revelations concerning the adverse cardiovascular effects of selective cyclooxygenase- 2 (COX-2) inhibitors has generally been framed as a story of regulatory failure, in which the Food and Drug Administration (FDA) has failed in its mission to protect the public from unsafe products. But this simplistic understanding of the mission of the FDA seems to make failure all but inevitable, if the reliable observation of the risks and benefits of a drug requires rigorous long-term studies. Perhaps in an earlier era the goal of drug regulation was simply to protect the public from poisons. Today, drug regulation guides …

Seeking Truth For Power: Informational Strategy And Regulatory Policymaking, Cary Coglianese, Richard Zeckhauser, Edward A. Parson

Articles

Information is the lifeblood of regulatory policy. The effective use of governmental power depends on information about conditions in the world, strategies for improving those conditions, and the consequences associated with deploying different strategies. Indeed, this need for information has led legislatures to create specialized committee structures, delegate policy authority to expert agencies, and develop administrative procedures that encourage analysis. Although legal scholars have extensively debated procedures and reforms designed to improve the analytic and scientific basis of regulatory policymaking, they have paid relatively little attention to how regulators gain the information they need for making and implementing regulatory policy. …

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 …

Administrative Agencies And The Court, Frank E. Cooper

Michigan Legal Studies Series

The limits which courts place on the powers of administrative tribunals have particular significance to practicing attorneys and law students. It is largely to the extent that such limits are imposed, that our government remains a government of laws and not a government of men.

The following pages have been written to describe the standards which the courts impose upon administrative agencies, thereby controlling and limiting their powers. More particularly, the writer has sought: (1) to bring together the leading cases in which the courts have laid down the principles that govern frequently litigated questions in contests between the agencies …