Law Commons^™

Illuminating Regulatory Guidance, Cary Coglianese

Michigan Journal of Environmental & Administrative Law

Administrative agencies issue many guidance documents each year in an effort to provide clarity and direction to the public about important programs, policies, and rules. But these guidance documents are only helpful to the public if they can be readily found by those who they will benefit. Unfortunately, too many agency guidance documents are inaccessible, reaching the point where some observers even worry that guidance has become a form of regulatory “dark matter.” This article identifies a series of measures for agencies to take to bring their guidance documents better into the light. It begins by explaining why, unlike the …

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 …

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 …

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.

Foreword: Rulemaking, Democracy, And Torrents Of E-Mail, Nina A. Mendelson

Articles

This Foreword is meant as an initial foray into the question of what agencies should do with mass public comments, particularly on broad questions of policy. Part I discusses the extent to which congressional control, presidential control, and agency procedures themselves can ensure that agency decisions are democratically responsive. In view of shortcomings in both congressional and presidential control, I underscore the need to focus closely on rulemaking procedures as a source of democratic responsiveness. The possibility that agencies may be systematically discounting certain public submissions raises difficulties, and I present some examples. Part II makes a preliminary case that …

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 …

Agency Hygiene, Nicholas Bagley

Articles

Prof. Bagley notes that reshaping captured agencies using the structural reforms suggested by Prof. Barkow may be politically infeasible and offers an alternative solution for eliminating interest-group capture. First, he suggests establishing a body within the Executive Branch that proactively investigates and documents capture dynamics. Second, he suggests creating legislative mechanisms that will encourage Congressional action on the body’s recommendations, and perhaps, more provocatively, requiring the Executive Branch to enact any such recommendations in the absence of Congress’s formal objection.

Disclosing 'Political' Oversight Of Agency Decision Making, Nina A. Mendelson

Articles

Scholars and courts have divided views on whether presidential supervision enhances the legitimacy of the administrative state. For some, that the President can supervise administrative agencies is key to seeing agency action as legitimate, because of the President's accountability to the electorate. Others, however, have argued that such supervision may simply taint, rather than legitimate, an agency action. The reality is that presidential supervision of agency rulemaking, at least, appears to be both significant and opaque. This Article presents evidence from multiple presidential administrations suggesting that regulatory review conducted by the White House's Office of Management and Budget is associated …

Regulatory Beneficiaries And Informal Agency Policymaking, Nina A. Mendelson

Articles

Administrative agencies frequently use guidance documents to set policy broadly and prospectively in areas ranging from Department of Education Title IX enforcement to Food and Drug Administration regulation of direct-to-consumer pharmaceutical advertising. In form, these guidances often closely resemble the policies agencies issue in ordinary notice-and-comment rulemaking. However, guidances are generally developed with little public participation and are often immune from judicial review. Nonetheless, guidances can prompt significant changes in behavior from those the agencies regulate. A number of commentators have guardedly defended the current state of affairs. Though guidances lack some important procedural safeguards, they can help agencies supervise …

The Sec At 70: Time For Retirement?, Adam C. Pritchard

Articles

The Article proceeds as follows. Part I explains the pathologies of the SEC and explores the relation between those pathologies and the SEC's status as an independent agency. Part II then outlines an alternative regulatory structure primarily situated within the executive branch. I also argue that such a relocation of authority would enhance regulatory effectiveness while simultaneously reducing the cost of excessive regulation. The Article concludes with some thoughts about the viability of my proposal.

The Sec At 70: Time For Retirement?, Adam C. Pritchard

Articles

As one grows older, birthdays gradually shift from being celebratory events to more reflective occasions. One's 40th birthday is commemorated rather differently from one's 2lst, which is, in turn, celebrated quite differently from one's first. After a certain point, the individual birthdays become less important and it is the milestone years to whch we pay particular attention. Sadly for entities like the Securities and Exchange Commission, it is only the milestone years (the ones ending in five or zero, for some reason), that draw any attention at all. No one held a conference to celebrate the SEC's 67th anniversary. Clearly …

Agency Burrowing: Entrenching Policies And Personnel Before A New President Arrives, Nina A. Mendelson

Articles

This Article examines executive branch agency actions concluded just before a new President takes office, such as "midnight" rulemaking and late-term hiring and promotion, which Professor Mendelson collectively refers to as "agency burrowing." Congress, the media, and some commentators have portrayed such activities as unsavory power grabs that undermine the President-elect's ability to direct the functions of administrative agencies. Rather than dismissing agency burrowing out of hand, however, Professor Mendelson argues for a more nuanced approach. In some cases, burrowing can make positive contributions to the democratic responsiveness of agencies, agency accountability, and the "rule of law." A fuller analysis …

Self-Regulation And Securities Markets, Adam C. Pritchard

Articles

Enron, Arthur Andersen, Tyco, ImClone, WorldCom, Adelphia - as American investors reel from accounting scandals and self-dealing by corporate insiders, the question of trust in the securities markets has taken on a new urgency. Securities markets cannot operate without trust. Markets known for fraud, insider trading, and manipulation risk a downward spiral as investors depart in search of safer investments. Today, many investors are rethinking the wisdom of entrusting their financial futures to the stock market. Absent trust in the integrity of the securities markets, individuals will hoard their money under the proverbial mattress.

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 …

The Obsolescence Of Wall Street: A Contextual Approach To The Evolving Structure Of Federal Securities Regulation, Joel Seligman

Michigan Law Review

As a matter of analytical style, this article illustrates a contextualist approach. For a considerable period of time, the dominant analytical style in corporate and securities .law has been a variant of economic, or law and economics, analysis. The virtue of this type of analysis is that it focuses on what its authors deem to be crucial variables and reaches conclusions derived from the core of a specific legal problem. The defect of this type of analysis is that so much is assumed or often assumed away.

Opinion Letter As To The Patentability Of Certain Inventions Associated With The Identification Of Partial Cdna Sequences, Rebecca S. Eisenberg, Robert P. Merges

Articles

You have asked for our legal opinion on the patentability of inventions claimed in U.S. patent applications 07/716,831, filed June 21, 1991 (the '831 application, or .'831"), 07/837,195, filed September 25, 1992 ("'195"), and 07/952,911, filed February 12, 1993 (."911"), all filed in the name of Craig Venter and others and assigned to the National Institutes of Health "(NIH)." We understand that NIH has abandoned these patent applications and has no present intention of filing similar applications in the future, but that NIH remains interested in the patenting of human DNA sequences from a broader public policy perspective. We have …

The Internationalization Of The Securities Markets: Preface To A Symposium, Joel Seligman

Michigan Journal of International Law

This preface begins by tracing certain of the initial steps taken by the SEC in the internationalization of securities trading. Regulations involving issuers of new securities are discussed in two contexts. First, when foreign private issuers offer securities into the United States, and second, when securities are simultaneously offered in the United States and abroad. The preface concludes by introducing each of the articles in this symposium.

Taking A Byte Out Of Abusive Agency Discretion: A Proposal For Disclosure In The Use Of Computer Models, John P. Barker

University of Michigan Journal of Law Reform

This Note examines the need for comprehensive requirements for the release of information pertaining to the use of computer-generated simulations used by federal administrative agencies or parties appearing before regulatory bodies. Part I of this Note defines computer models, identifies some of their current uses in administrative proceedings and describes the advantages of these models. Part II reviews the current requirements for documentation of computer models and the judicial review standards for agency findings. Part III examines the potential problems in the use of models and discusses the need for more adequate disclosure. Part IV describes several tests for verifying …

Federal Agency Access To Grand Jury Transcripts Under Rule 6 (E), Michigan Law Review

Michigan Law Review

Part I examines the courts' current certainty-based perspective, and rejects this approach because it sacrifices important interests in civil law enforcement and judicial consistency for speculative and coincidental reductions in grand jury abuse. Part II defends the proposed standard by arguing that it comports with the language and intent of the rule while more effectively advancing the policy interests in civil law enforcement and grand jury secrecy.

The Sec And Corporate Disclosure: Regulation In Search Of A Purpose, Michigan Law Review

Michigan Law Review

A Book Notice about The SEC and Corporate Disclosure: Regulation in Search of a Purpose by Homer Kripke

Souped Up Affirmative Disclosure Orders Of The Federal Trade Commission, William F. Lemke Jr.

University of Michigan Journal of Law Reform

Under section 5(b) of the Federal Trade Commission Act the Commission is given authority to conduct hearings, make findings and issue cease and desist orders requiring any person, partnership or corporation to cease and desist from use of unfair methods of competition or unfair or deceptive practices in commerce. The Commission also issues consent orders in cases which are concluded by agreement between the Commission and the allegedly offending party. Consent orders have the same force and binding effect as those issued after hearings and findings. Although it is well established that the Commission has very broad discretion and authority …

Federal Agency Investigations: Requirements For The Production Of Documents, Frank E. Cooper

Michigan Law Review

The United States district courts are frequently called upon to decide whether an administrative agency is entitled to enforcement of a subpoena requesting production of documentary evidence which the person to whom the subpoena is addressed assails as an unnecessary and improper inquisitorial investigation.

Neither the statute nor the decision-landmarks though they both are-offers a convenient rule of thumb to guide the district courts in the intensely difficult problems posed by requests for enforcement of administrative subpoenas.

However, an examination of the decisions passing upon such requests does disclose the standards by which the courts apply the three classic tests, …

The Civil Investigative Demand: New Fact-Finding Powers For The Antitrust Division, Richard L. Perry, William Simon

Michigan Law Review

The complexity, scope and length of modem antitrust litigation bring to prominence the procedures by which evidence - particularly documentary evidence - is discovered and placed before the courts and administrative agencies. Fact-finding mechanisms now available for ferreting out and prosecuting violations make up an imposing array. These include the grand jury subpoena, the discovery provisions of the Federal Rules of Civil and Criminal Procedure and the subpoena and visitorial powers of certain administrative agencies. The "civil investigative demand," a precomplaint compulsory process, is a new weapon proposed to be added to this arsenal. Few dispute the desirability of new …