Food and Drug Law Commons^™

Protecting Scientific Integrity: The Commercial Speech Doctrine Applied To Industry Publications, Joanna K. Sax

Faculty Scholarship

Pharmaceutical companies face increasing pressure to bring new treatments to market in order to survive. The economic reality of survival and profits may distort a company’s decision-making process regarding full disclosure on a particular new drug.

Part II of this article analyzes the publication tactics employed by some members of the pharmaceutical industry (hereinafter “industry”) and explains how some of the publications promote misleading information. Part III proposes policy recommendations to require accurate dissemination of the results of clinical trials in order to protect scientific integrity and the public welfare. Part IV of this article addresses whether industry publications are …

The Case For Legal Regulation Of Physicians’ Off-Label Prescribing, Doriane Lambelet Coleman, Philip M. Rosoff

Faculty Scholarship

No abstract provided.

Regulating Tobacco Advertising And Promotion: A "Commerce Clause" Overview For State And Local Governments, Kathleen Dachille

Faculty Scholarship

On June 22, 2009, President Barack Obama signed into law the Family Smoking Prevention and Tobacco Control Act, giving the U.S. Food and Drug Administration (FDA) comprehensive authority to regulate the manufacturing, marketing, and sale of tobacco products. The new law represents the most sweeping action taken to date to reduce what remains the leading preventable cause of death in the United States.

To help you understand the potential ways in which state and local regulation of tobacco product marketing and promotion might be limited by the U.S. Constitution’s Commerce Clause, the Tobacco Control Legal Consortium, a collaborative network of …

Regression By Progression Unleveling The Classroom Playing Field Through Cosmetic Neurology, Helia Garrido Hull

Faculty Scholarship

No abstract provided.

Private Regulation And Foreign Conduct, Adam I. Muchmore

Faculty Scholarship

Current U.S. policy on safety regulation for imported food is based largely on ex post measures. Several reform proposals seek to strengthen the ex ante component of this regulatory program. These proposals rely on one or more of three basic strategies: direct extraterritorial regulation; delegation of regulatory authority to private entities; and delegation of regulatory authority to foreign government agencies. This paper explores the ability of each strategy to respond to several principal-agent problems relevant to imported-food safety: the regulatory license problem; interest group capture; and the reality of bribery and threats in many food-exporting countries. Through the lens of …

An Information Prescription For Prescription Drug Regulation, Anita Bernstein, Joseph Bernstein

Faculty Scholarship

No abstract provided.

Making Sense Of Drug Regulation: A Theory Of Law For Drug Control Policy , Kimani Paul-Emile

Faculty Scholarship

This article advances a new theory of drug regulation that addresses two previously unexamined questions: how law-makers are able to regulate drugs differently irrespective of the dangers the drugs may pose and independent of their health effects, and the process followed to achieve this phenomenon. For example, although tobacco products are the leading cause of preventable death in the U.S. they can be bought and sold legally by adults, while marijuana, a substantially safer drug, is subject to the highest level of drug control. This article posits a conceptual model for making sense of this dissonance and applies this model …

Regulatory Dysfunction: How Insufficient Resources, Outdated Laws, And Political Interference Cripple The 'Protector Agencies', Sidney A. Shapiro, Rena I. Steinzor, Matthew Shudtz

Faculty Scholarship

In the last several years, dramatic failures of the nation’s food safety system have sickened or killed tens of thousands of Americans, and caused billions of dollars of damages for producers and distributors of everything from fresh vegetables to granola bars and hamburger meat. In each case, the outbreak of food-borne illness triggered what can only be described as a frantic scramble by health officials to discover its source. Inevitably, the wrong lead is followed or a recall is too late or too narrow to prevent further illnesses, and the government has to defend itself against withering criticism. Americans expect …

Pharmaceutical Innovation: Law & The Public's Health, Kevin Outterson

Faculty Scholarship

At last count, global pharmaceutical spending exceeded $750 billion. Unlike most medical products and services, many pharmaceuticals are sold at a price that greatly exceeds marginal cost. AIDS medicines that retail for over $10,000 per person per year in the United States can be produced generically at a marginal cost of less than $150. Patents and other related IP rights create these significant gaps between marginal cost and retail price, generating many billions of dollars in profits (patent rents) for companies.

Cloned Meat, Voluntary Food Labeling, And Organic Oreos, Donna M. Byrne

Faculty Scholarship

In December 2006, the Food and Drug Administration (FDA) announced that it had reviewed all the available evidence and was poised to approve meat and milk from cloned animals and their progeny. Such products, said the FDA, are virtually identical to meat or milk from a non-clone. Further, the FDA announced it would almost certainly not require food from clones to be labeled as such. Part I of this article identifies three functions that labels perform, outlines the types of information usually required, and introduces the rule that voluntary label information cannot be misleading. Part II focuses on process information …

Compulsory Licensing Of Patented Pharmaceutical Inventions: Evaluating The Options, Jerome H. Reichman

Faculty Scholarship

In this Comment, the author traces the relevant legislative history pertaining to compulsory licensing of patented pharmaceuticals from the TRIPS Agreement of 1994 to the 2003 waiver to, and later proposed amendment of, article 31, which enables poor countries to obtain needed medicines from other countries that possess manufacturing capacity. The Comment then evaluates recent, controversial uses of the relevant legislative machinery as viewed from different critical perspectives. The Comment shows how developing countries seeking access to esential medicines can collaborate in ways that would avoid undermining incentives to innovation and other social costs attributed to compulsory licensing. It ends …

Rethinking The Role Of Clinical Trial Data In International Intellectual Property Law: The Case For A Public Goods Approach, Jerome H. Reichman

Faculty Scholarship

This article is a later version of the author's presentation at the Eleventh Annual Honorable Helen Wilson Nies Memorial Lecture March 26, 2008. Clinical trials are currently used to test drugs; however, the risk and cost of clinical trials are increasing so drastically that the clinical trials may become unsustainable. This article evaluates the legal and economic trends of intellectual property protection for pharmaceutical clinical trial data. The protection of clinical trials has become an alternative to patents as market exclusivity encourages the development and testing of unpatentable pharmaceuticals. This author argues that clinical trials should be treated as a …

Dirty Dancing: The Fda Stumbles On The Chevron Two-Step, Gary S. Lawson

Faculty Scholarship

Professor Lars Noah deserves much credit for exposing some of the myriad ways in which the Food and Drug Administration (FDA) has consistently sought to expand its authority through questionable, and perhaps in some cases abusive, legal practices.' As Professor Noah observes, there are signs that the federal courts' century-long honeymoon with the FDA may be ending 2 -and perhaps the FDA never deserved the solicitude that it has traditionally received from both the judiciary and Congress. 3 If Professor Noah can hasten the onset of a more realistic legal and public attitude toward the FDA, he will have performed …

The Vioxx Litigation: Two Case Studies, Michael E. Tigar

Faculty Scholarship

No abstract provided.

Enhancing Drug Effectiveness And Efficacy Through Personal Injury Litigation, Anita Bernstein

Faculty Scholarship

No abstract provided.

Knowledge Commons: The Case Of The Biopharmaceutical Industry, Arti K. Rai

Faculty Scholarship

No abstract provided.

Book Review: Michele Goodwin's Black Markets: The Supply And Demand Of Body Parts, Barbara A. Noah

Faculty Scholarship

The Author reviews Michele Goodwin’s book BLACK MARKETS: THE SUPPLY AND DEMAND OF BODY PARTS, published by Cambridge University Press, 2006. The book discusses the shortage of cadaveric organs available for transplantation. It argues that the shortage disproportionately impacts racial minorities. It then analyzes existing organ procurement laws and proposed alternatives, with a focus on market solutions.

BLACK MARKETS is impeccably researched and persuasively argued, though some of its points are certainly controversial. The book is aimed at and very accessible to a general audience, but it will also prove interesting and informative to legal, medical and public health academic …

Liability For Direct Advertising Of Drugs To Consumers: An Idea Whose Time Has Not Come, Aaron Twerski

Faculty Scholarship

No abstract provided.

Protecting Protected Speech: First Amendment Taxonomy And The Food And Drug Administration's Regulation Of "Enduring Materials", Daniel J. Gilman

Faculty Scholarship

Numerous comments have called upon the Food and Drug Administration (FDA) to exercise restraint in its treatment of the dissemination of “enduring materials” (e.g., textbooks, journal articles, etc.) that address off-label uses of drug or biological products. This article considers the constitutional protections that apply to enduring materials as examples of commercial speech, and questions whether such materials—even though distributed by manufacturers—might be viewed more properly as scientific speech. Four conclusions will be set forth: 1) enduring materials regarding off-label uses deserve at least as much protection as the Constitution affords commercial speech; 2) there are good reasons to think …

How A Drug Becomes ‘Ethnic’: Law, Commerce, And The Production Of Racial Categories In Medicine, Jonathan Kahn

Faculty Scholarship

A drug called BiDil is poised to become the first drug ever approved by the Food and Drug Administration (FDA) to treat heart failure in African Americans - and only African Americans. This article explores the story of BiDil and considers some of its broader implications for the use of racial categories in law, medicine, and science. It argues that BiDil is an ethnic drug today as much, if not more because of the interventions of law and commerce as because of any biomedical considerations. The article is, first, a retrospective analysis of how law, commerce, science, and medicine interacted …

The Implementation Of Fda Determinations In Litigation - Why Do We Defer To The Pto But Not To The Fda?, William G. Childs

Faculty Scholarship

This Article examines the possible inequity of the treatment of licensees' rights in tort litigation in comparison to patent rights in patent litigation. In particular, this Article presents the presumptions afforded from issued patents as a valid model for the proper treatment of FDA approval in litigation. Presently, most academic discussion proposes either preclusion of tort claims or leaving the system more or less as it stands. This Article, on the other hand, proposes a middle ground.

This Article begins by examining the differences between the USPTO and the FDA. In particular, the quantity and quality of the review provided …

Can We Talk? About Food And Drug Regulation And The First Amendment, Marsha N. Cohen

Faculty Scholarship

No abstract provided.

Pharmacogenomics, Genetic Tests, And Patent-Based Incentives, Michael J. Meurer

Faculty Scholarship

Pharmacogenomics promises to revolutionize medicine by using genetic information to guide drug therapy. Genetic tests will help doctors improve drug safety and efficacy by better matching patients and drugs. This Article evaluates the effectiveness of patent-based incentives to create genetic tests, and the optimal mix of public and private sector pharmacogenomic R&D. Drug patent owners have a strong incentive to develop genetic tests that predict adverse drug reactions and allow them to market drugs that otherwise would be shelved. Incentives are also strong for genetic tests that are created as part of the drug development process. Incentives tend to be …

Problem-Solving Courts: From Innovation To Institutionalization, Michael C. Dorf, Jeffrey A. Fagan

Faculty Scholarship

The phenomenal growth of drug courts and other forms of "problem-solving" courts has followed a pattern that is characteristic of many successful innovations: An individual or small group has or stumbles upon a new idea; the idea is put into practice and appears to work; a small number of other actors adopt the innovation and have similar experiences; if there is great demand for the innovation – for example, because it responds to a widely-perceived crisis or satisfies an institutional need and resolves tensions within organizations that adopt it – the innovation rapidly diffuses through the networks in which the …

Drug Designs Are Different, Aaron Twerski, J. A. Henderson

Faculty Scholarship

No abstract provided.

Making Clinical Trials Safer For Human Subjects, Michael S. Baram

Faculty Scholarship

Clinical trials, in which new biotech and other medical products are tested on human subjects, provide much of the data used by the FDA to determine whether the products are suitable for routine use in health care. Thus, the trials are of obvious importance to medical progress and improvement of public health, and to those who have career and financial interests at stake. But clinical trials are also important to the human subjects involved because the products being tested on them may remedy their illnesses, but may also pose risks since the products have usually not been previously tested on …

Breaking The Federal/State Impasse Over Medical Marijuana: A Proposal, Marsha N. Cohen

Faculty Scholarship

No abstract provided.

Measuring Culpability By Measuring Drugs? Three Reasons To Re-Evaluate The Rockefeller Drug Laws, Susan Herman

Faculty Scholarship

No abstract provided.

Increasing Access To Emergency Contraceptive Pills Through State Law Enabled Dependent Pharmacist Prescribers, Heather M. Field

Faculty Scholarship

No abstract provided.

Adverse Drug Reactions: Harnessing Experiential Data To Promote Patient Welfare, Barbara A. Noah

Faculty Scholarship

Part I of this Article evaluates the pre-approval and post-approval regulatory framework governing prescription drugs, and the FDA's spontaneous reporting system for adverse events, as it contrasts that system with the regulatory mechanisms used to monitor risks associated with other products. Part II summarizes the recent series of prescription drug marketing withdrawals prompted by reports of unexpected adverse reactions. Finally, Part III offers some possible solutions designed to improve the efficiency of postapproval surveillance so that fewer patients will suffer the consequences of unexpected adverse drug reactions and interactions. This Article concludes that the existing regulatory system requires fundamental reprioritization …