Law Commons^™

Trading Pain For Gain: Addressing Misaligned Interests In Prescription Drug Benefit Administration, Sheva J. Sanders, Jessica C. Wheeler

University of Michigan Journal of Law Reform

Over the last two decades, Pharmacy Benefit Managers (PBMs), organizations that act as middlemen between health plans and drug manufacturers, have become increasingly powerful players in the healthcare industry. PBMs promise to leverage their expertise and ability to aggregate buying power to negotiate lower drug prices and administer prescription drug benefit plans. In practice, however, PBMs are widely criticized for benefitting from, and contributing to, inefficiencies in the prescription drug market, particularly by imposing restrictions on beneficiary access to drugs in exchange for rebates paid to PBMs by manufacturers. To the extent that the rebates are retained by PBMs, or …

Take It With A Grain (Or More) Of Salt: Why Industry-Backed Dietary Guidelines Fail Americans And How To Fix Them, Caroline Farrington

University of Michigan Journal of Law Reform

The U.S. Dietary Guidelines lack oversight and accountability. The result: Guidelines that reflect food industry interests instead of modern science. This deleterious guidance goes on to govern federally-subsidized food assistance programs and to influence dietary choices throughout the private sector and private life. Ultimately, the Guidelines significantly contribute to the endemic chronic disease they seek to address.

The Guidelines Advisory Committee is notoriously rife with conflicts of interest, and thus most Guidelines scholarship has focused on reforming the Committee. But the 2015 and 2020 Guidelines show that these reforms are insufficient and agency-level change is necessary. In 2015, the Committee …

Tell Me How It Ends: The Path To Nationalizing The U.S. Pharmaceutical Industry, Fran Quigley

University of Michigan Journal of Law Reform

The U.S. medicines system is broken. Millions of Americans suffer and some even die because they cannot afford medicines discovered by government-funded research. At the same time, corporations holding monopoly patent rights to those medicines collect some of the largest profits in modern capitalist history.

It does not have to be this way. The global legacy of treating essential medicines as a public good and the robust U.S. history of government seizure of private property for the public interest reveals a better path: the United States should nationalize its pharmaceutical industry.

U.S. statutory law already provides broad powers for the …

Restructuring Local School Wellness Policies: Amending The Kids Act To Fight Childhood Obesity, Rebecca Edwalds

University of Michigan Journal of Law Reform

Childhood obesity is a major problem plaguing the United States. Over one-third of children are overweight, and there is little indication that this trend will reverse in the near future. The federal government has attempted to combat childhood obesity through the National School Lunch Act, which regulates the quality of foods federally subsidized schools may serve to children, and provides broad goals for physical activity. These basic goals leave extensive room for states to implement different standards, and they are not sufficient to effectively confront the childhood obesity problem. This Note proposes amendments to the National School Lunch Act that …

Taxing Food And Beverage Products: A Public Health Perspective And A New Strategy For Prevention, Jennifer L. Pomeranz

University of Michigan Journal of Law Reform

The power to tax and spend is considered a primary government power, and the use thereof is associated with great public health achievements. The greatest public health challenge at present stems from the increase in obesity and chronic diseases due to poor nutrition. Several taxation strategies have emerged in the health and economic literature to raise revenue, deter consumption, and address food prices and obesity directly. These proposals include taxing obese individuals, taxing problematic food products, and instituting a tax based on certain food components. This article weighs each proposal's value and disadvantages and concludes by proposing a new tax …

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.

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 …

Transplant Candidates And Substance Use: Adopting Rational Health Policy For Resource Allocation, Erin Minelli, Bryan A. Liang

University of Michigan Journal of Law Reform

Organ transplant candidates are often denied life saving organs on account of their medical marijuana drug use. Individuals who smoke medicinal marijuana are typically classified as substance abusers, and ultimately deemed ineligible for transplantation, despite their receipt of the drug under a physician's supervision and prescription. However, patients who smoke cigarettes or engage in excessive alcohol consumption are routinely considered for placement on the national organ transplant waiting list. Transplant facilities have the freedom to regulate patient selection criteria with minimal oversight. As a result, the current organ allocation system in the United States is rife with inconsistencies and results …

The Moral Hazard Problem With Privatization Of Public Enforcement: The Case Of Pharmaceutical Fraud, Dayna Bowen Matthew

University of Michigan Journal of Law Reform

This Article takes a law and economics approach to exploring some of the costs that arise when governments rely on private enforcement to accomplish the goals of public law. The analysis focuses on qui tam enforcement under the Civil False Claims Act, because a remarkable body of empirical data demonstrates the expansive role private qui tam relators are playing in enforcing Medicare and Medicaid fraud and abuse laws. The Article further focuses on the application of these laws to the pharmaceutical industry. This focus is enlightening because the Government, as well as private enforcers, have recently targeted this industry so …

Seeds Of Distrust: Federal Regulation Of Genetically Modified Foods, Thomas O. Mcgarity

University of Michigan Journal of Law Reform

This Article describes and evaluates the existing federal regulatory regime for protecting public health from risks posed by foods derived from GM plants. Part I briefly describes the technology involved in genetically modifying plants and relates the ongoing debates over the risks and benefits of GM food plants. Part II examines in detail the regulatory regime that has evolved in the United States to regulate the safety of GM foods, focusing in particular upon the pervasive role that the substantial equivalence doctrine has played in that regime. Finally, Part III suggests a more precautionary approach toward regulating GM foods that …

Extraditing Mexican Nationals In The Fight Against International Narcotics Crimes, Joshua S. Spector

University of Michigan Journal of Law Reform

In recent years, Mexican narcotics trafficking has become a major threat to the security of the Americas. Mexican narco-traffickers have used their wealth and violence to corrupt political and judicial systems and avoid effective prosecution or penalty in Mexican courts. Historically, Mexico has refused to extradite its nationals in reliance on Mexican law prohibiting the extradition of nationals in all but "exceptional" cases. This Note argues that Mexico should take a step toward controlling the cross-border narcotics trade and recognize international drug trafficking as an "exceptional" crime. Upon recognizing narcotics crimes as "exceptional," Mexico should then begin extraditing Mexican narco-traffickers …

Proposition 215: De Facto Legalization Of Pot And The Shortcomings Of Direct Democracy, Michael Vitiello

University of Michigan Journal of Law Reform

In 1996, California voters passed Proposition 215, officially titled The Compassionate Use Act of 1996, and popularly known as the "medical marijuana" initiative. This initiative allows qualifying people and their caregivers immunity from criminal prosecution when the state attempts to charge them with possession or cultivation of marijuana. Professor Vitiello uses the medical marijuana initiative as a case study illustrating flaws in California's ballot initiative process He examines the history of the initiative process in California, misleading aspects of the campaign for Proposition 215, and ambiguities in the proposition's language. Concluding that the initiative process as it now stands fosters …

Statutory Compliance And Tort Liability: Examining The Strongest Case, Michael D. Green

University of Michigan Journal of Law Reform

Professor Green addresses the matter of the proper balance between the tort system and regulation in the context of prescription drugs and the FDA's vigorous oversight of the industry. He articulates several reasons why a regulatory compliance defense, in which tort law would defer to FDA regulation, is quite attractive. Despite the superior expertise of the FDA in assessing the benefits and risks of a drug, a regulatory compliance defense is considerably more problematical than might appear at first glance. Ascertaining compliance with FDA requirements could be a lengthy and complicated inquiry that would either replace or supplement the issues …

Ru 486 Examined: Impact Of A New Technology On An 0 Id Controversy, Gwendolyn Prothro

University of Michigan Journal of Law Reform

Abortion is an extremely divisive issue in American politics and culture. Prothro begins this Article by analyzing the current legal standards governing reproduction, which draw a sharp distinction between abortion and contraception. Prothro then examines the function of RU 486, demonstrating that it acts both as a contraceptive and as an abortifacient. Because of this dual capacity, RU 486 does not fit neatly into the current legal framework. Prothro concludes this Article by arguing that RU 486 should force the Supreme Court to create a new framework for the "procreative right." Prothro argues that this new framework should treat the …

Reforming The Ncaa Drug-Testing Program To Withstand State Constitutional Scrutiny: An Analysis And Proposal, Thomas P. Simon

University of Michigan Journal of Law Reform

Shortly after year-round testing went into effect, the California Court of Appeal held that the NCAA's original drug testing program violated a student-athlete's right of privacy as protected by the California Constitution. This Note examines the impact of that decision and attempts to design a program that will withstand state constitutional scrutiny. Part I describes the current NCAA drug-testing program. Part II looks at the fourth amendment argument against drug testing of student-athletes. Part III assesses the viability of a federal constitutional attack on NCAA testing, while Part IV discusses a state constitutional challenge. Finally, Part V proposes reform of …

The Application Of A Due Diligence Requirement To Market Share Theory In Des Litigation, Thomas C. Willcox

University of Michigan Journal of Law Reform

This Note argues that courts should impose a due diligence requirement on plaintiffs as a prerequisite to the use of market share theory. Part I examines traditional products liability theories along with alternative theories and explains the relationship of due diligence to market share theory. Part II argues that due diligence should be a prerequisite to market share liability. Part III discusses the nature of due diligence in this context. Finally, Part IV considers various objections to a due diligence requirement and argues that they are essentially without merit.

The Monopoly Component Of Inflation In Food Prices, Neal Smith

University of Michigan Journal of Law Reform

Part I examines monopoly power in the food industry, paying close attention to the increased economic strength of monopolies and the economic costs caused by monopoly power. Part II details the problems resulting from monopoly power in one segment of the food industry-the meatpacking industry. Part III calls upon the Congress to undertake new antitrust initiatives to reverse the food industry's trend toward increasing concentration. It cannot be said with certainty that food price inflation would totally disappear if the consumer loss due to monopoly were removed from the food manufacturing and retailing sectors. Doing away with these losses, however, …

Decriminalizing The Marijuana User: A Drafter's Guide, Richard J. Bonnie

University of Michigan Journal of Law Reform

The article does not discuss the arguments in favor of decriminalization, a matter which the author' and others have covered elsewhere. Nor does the article consider the even more difficult questions involved in a legislative decision to legalize the drug and authorize its distribution for nonmedical uses. International obligations, federal law, and current political realities preclude enactment of a regulatory approach toward the availability of marijuana, including any variant of the so-called alcohol model. Although a state conceivably could repeal its laws against cultivation and distribution of marijuana, including only the federal prohibitions in effect, such an overt departure from …

Legislative Notes: The Fda's Over-The Counter Drug Review: Expeditious Enforcement By Rulemaking, David Selmer

University of Michigan Journal of Law Reform

This article attempts to show that the OTC drug review has distinct advantages over traditional drug regulation. Part I outlines briefly the traditional case-by-case approach to drug licensing and describes FDA enforcement efforts prior to the OTC drug review. Part II sets forth the new rulemaking approach and considers the use of advisory panels. Part III examines several procedural questions associated with the review and concludes that the use of monographs as regulatory standards will afford the FDA an expeditious enforcement mechanism by resolving complex scientific issues at the administrative rather than the judicial level. Judicial review should be available, …

Improving Michigan's Generic Drug Law, Phyllis Greenwood Rozof

University of Michigan Journal of Law Reform

This note will describe the conditions which existed prior to enactment of the Michigan drug substitution law, will discuss the history and provisions of that legislation, and will identify certain problems which the law fails to correct.

Toward An International System Of Drug Control, Louis Lessem

University of Michigan Journal of Law Reform

By any measure the ongoing explosion in the abuse and trafficking of illicit drugs must be viewed as alarming. The past few years have seen a dramatic upsurge in the use of heroin and other opiates, the re-emergence of cocaine as a popular drug, and expansion of the use and availability of synthetic and psychotropic substances, and, perhaps of greatest international concern, the penetration of illicit narcotics into markets hitherto relatively free from drug involvement. Western Europe, Canada, and most recently the Soviet Union1 have reported the growth of drug-consuming populations. At the same time, there has been an awakened …

The Prosubstitution Trend In Modern Pharmacy Law, Sidney H. Willig

University of Michigan Journal of Law Reform

This article explores the legal problems presented to the practicing pharmacist by drug substitution. It delineates the practical and economic realities bearing on substitution and the arguments both in favor of and against limited legal substitution. After describing the current status of the law on the subject and the various resultant liabilities of the pharmacist, the article then suggests means by which substitution might be made an acceptable practice in certain circumstances.