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Full-Text Articles in Food and Drug Law
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.
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 …
Transplant Candidates And Substance Use: Adopting Rational Health Policy For Resource Allocation, Erin Minelli, Bryan A. Liang
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
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 …
Extraditing Mexican Nationals In The Fight Against International Narcotics Crimes, Joshua S. Spector
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 …
Statutory Compliance And Tort Liability: Examining The Strongest Case, Michael D. Green
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 …
The Application Of A Due Diligence Requirement To Market Share Theory In Des Litigation, Thomas C. Willcox
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.
Decriminalizing The Marijuana User: A Drafter's Guide, Richard J. Bonnie
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
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
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
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
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.