Food and Drug Law Commons^™

The Food And Drug Administration's Evolving Regulation Of Press Releases: Limits And Challenges, William W. Vodra, Nathan Cortez, David E. Korn

Faculty Journal Articles and Book Chapters

The Food and Drug Administration (FDA) has developed an informal framework for regulating press releases by drug and medical device companies. FDA asserted jurisdiction over press releases based on its authority over labeling and advertising, and over the past 20 years, the agency has both broadened and scaled back its claims to authority over press statements.

Despite a somewhat predictable framework for anticipating how FDA regulates press materials, the agency's approach appears to be in flux. FDA will not tolerate false or misleading statements in press materials, but there are legal and practical limits to its regulation in this area. …

Merck V. Integra And Its Aftermath: A Safe Harbor For The Commercial Use Of Biotechnology Research Tools?, Brendan M. O'Malley

Cardozo Arts & Entertainment Law Journal

No abstract provided.

United States Food Law Update, Michael Tingey Roberts

Journal of Food Law & Policy

This update summarizes significant changes and developments in food law over the first half of 2005. Not every change in national food law for the first half of 2005 is included; instead, this update is limited to significant changes in national law. New developments in state law, while certainly important and deserving of attention, are beyond the scope of this update. These updates provide a starting point for scholars, practitioners, food scientists, and policymakers determined to understand the shaping of food law in modem society. Tracing the development of food law through these updates also builds an important historical context …

Deadly Discounts: How Reimportation Jeopardizes The Safety Of The U.S. Pharmaceutical Drug Supply Under The Federal Trade Commission Amendment, Nicole C. Bates

ExpressO

The amendment to a Federal Trade Commission (FTC) reauthorization bill, previously introduced as Senate Bill 334 (S.334) Pharmaceutical Market Access and Drug Safety Act of 2005 allows for the reimportation of prescription drugs into the United States from approximately 25 countries, including Canada via Internet pharmacies. There are no guarantees that the internet websites advertising as Canadian pharmacies are legitimate. The shipping of pharmaceutical drugs occurs through importation, which refers to drugs produced abroad then later shipped to the U.S., or re-importation, a term applied when drugs are produced in the U.S. and exported for sale to foreign countries and …

Blame Canada (And The Rest Of The World): The Twenty-Year War On Imported Prescription Drugs, Daniel L. Pollock

ExpressO

Rising budget deficits and sticker shock over the new Medicare drug benefit have put the issue of prescription drug costs back into the spotlight. The growth in the cost of prescription drugs continues to represent a staggering burden for taxpayer-funded health care programs, even while costs of non-drug health care services have slowed or even decreased. Among the many proposals for cutting prescription drug costs, drug importation is unique. Although bipartisan support for drug importation has existed in Congress for over five years, the federal government continues to maintain that a system of safe and effective drug importation is impossible. …

Project Bioshield, More Than Meets The Eye: A Critique Of The U.S.’S Proposed Silver Bullet For Responding To Bio-Terrorism, Jodi A. Phillipo

ExpressO

No abstract provided.

Breaking The Bank: Revisiting Central Bank Of Denver After Enron And Sarbanes-Oxley, Celia Taylor

ExpressO

No abstract provided.

“Racially-Tailored” Medicine Unraveled, Sharona Hoffman

ExpressO

In June 2005, the FDA approved BiDil, a heart failure medication that is labeled for use only by African-Americans and thus, is the first treatment of its kind. The drug likely portends a future of growing interest in “race-based” medicine. This phenomenon is emerging at the same time that scientists, in light of the Human Genome Project, are reaching an understanding that “race” has no biological meaning, and consequently, “racially-tailored” medicine is both puzzling and troubling.

This Article explores the reasons for the new focus on “racial-profiling” in medicine. It analyzes the risks and dangers of this approach, including medical …

Learning The Wrong Lessons From "An American Tragedy": A Critique Of The Berger-Twerski Informed Choice Proposal, David E. Bernstein

George Mason University School of Law Working Papers Series

This paper is a critique of Margaret Berger and Aaron Twerski, “Uncertainty and Informed Choice: Unmasking Daubert”, forthcoming the Michigan Law Review. Berger and Twerski propose that courts recognize a cause of action that would allow plaintiffs who claim injury from pharmaceutical products, but who do not have sufficient evidence to prove causation, to recover damages for deprivation of informed choice. Berger and Twerski claim inspiration from the litigation over allegations that the morning sickness drug Bendectin caused birth defects. Considering the criteria Berger and Twerski suggest for their proposed cause of action in the context of Bendectin, it appears …

Note: A Painful Catch-22: Why Tort Liability For Inadequate Pain Management Will Make For Bad Medicine, James R. Blaufuss

William Mitchell Law Review

Part I of this note reviews current issues relating to pain treatment. Part II examines theoretical justifications of proposed tort liability for inadequate pain management. Part III examines how pain mismanagement does not fit within traditional notions of medical malpractice. Part IV studies the issues relating to a physician’s role as “gate-keeper” for opioids and suggests why tort liability could compromise this legislatively imposed role. Part V examines the issue of pain management in the context of end-of-life care. Part VI discusses current shifts in pain management philosophies and explains how these movements will effectuate the changes suggested by advocates …

Stemming The Tide Of Stem Cell Research: The Bush Compromise, 38 J. Marshall L. Rev. 1061 (2005), Patrick Walsh

UIC Law Review

No abstract provided.

"Racially-Tailored" Medicine Unraveled, Sharona Hoffman

American University Law Review

In June 2005, the FDA approved BiDil, a heart failure medication that is labeled for use only by African-Americans and thus is the first treatment of its kind. The drug likely portends a future of growing interest in "race-based" medicine. This phenomenon is emerging at the same time that scientists, in light of the Human Genome Project, are reaching an understanding that "race" has no biological meaning, and consequently, "racially-tailored" medicine is both puzzling and troubling. This Article explores the reasons for the new focus on "racial-profiling" in medicine. It analyzes the risks and dangers of this approach, including medical …

Battle Of The Beef, The Rematch: An Evaluation Of The Latest E.C. Directive Banning Beef Produced With Growth Hormones And The U.S. Refusal To Accept The Directive As Wto Compliant, Darrel Chichester

American University International Law Review

No abstract provided.

Access To Justice And The Right To Adequate Food: Implementing Millennium Development Goal One, Marc J. Cohen, Mary Ashby Brown

Sustainable Development Law & Policy

No abstract provided.

Pharmaceutical Tort Liability: A Justifiable Nemesis To Drug Innovation And Access?, 38 J. Marshall L. Rev. 987 (2005), Paula Jacobi

UIC Law Review

No abstract provided.

Patients Beware: Preemption Of Common Law Claims Under The Medical Device Amendments, 39 J. Marshall L. Rev. 75 (2005), Michael P. Dinatale

UIC Law Review

No abstract provided.

Regulating The Regulators: The Impact Of Fda Regulation On Corporations' First Amendment Rights, 39 J. Marshall L. Rev. 95 (2005), Lisa M. Fealk-Stickler

UIC Law Review

No abstract provided.

Public Use Or Experimental Use: Are Clinical Trials Susceptible To Another Attack Similar To That In Smithkline Beecham Corp. V. Apotex Corp., 39 J. Marshall L. Rev. 149 (2005), Nimalka Wickramasekera

UIC Law Review

No abstract provided.

Minnesota: Leading The Way On Canadian Prescription Medicine Importation, Kevin Goodno, Karen Janisch

William Mitchell Law Review

In the United States, about $160 billion is spent on prescription medicines each year, with Minnesotans spending about $3 billion. The costs of prescription medicines receive so much attention in large part because, although prescription medicine costs constitute only 10.5% of total health care spending, they account for 23% of the total out-of-pocket costs that people incur when purchasing health care. Minnesota has been a leader in controlling prescription medicine costs. It has aggressively used purchasing pools when possible, and encouraged the use of lower cost, generic prescription medicines when appropriate. Even with these efforts to control costs, prescription medicines …

Aetna V. Davila/Cigna V. Calad: A Missed Opportunity, Leonard A. Nelson

William Mitchell Law Review

On June 21, 2004, the United States Supreme Court decided the health law “case of the year” in the two consolidated cases of Aetna Health, Inc. v. Davila and CIGNA HealthCare of Texas, Inc. v. Calad. The Court held that section 502(a) of the Employee Retirement Income Security Act of 1974 (ERISA) “completely preempt[s]” and thus invalidates the tort liability provisions of the Texas Health Care Liability Act (THCLA). The case could potentially affect the rights of millions of Americans in a matter of vital concern—whether they will receive the health insurance coverage promised them if they become unable to …

Off-Label Use And The Medical Negligence Standard Under Minnesota Law, Cynthia A. Moyer

William Mitchell Law Review

Who decides whether a drug can be used off-label and under what circumstances? If a physician decides to prescribe a drug off-label, what legal issues, if any, should the physician be aware of? With the increased practice of prescribing drugs for off-label use, coupled with a somewhat dated and incomplete medical negligence standard in Minnesota, the intersection of the off-label use doctrine with Minnesota’s medical negligence standard is ripe for review. This article examines the off-label use doctrine and the medical negligence standard under Minnesota law. First, the article examines what the phrase “off-label use” means. Next, the article explores …

Molloy V. Meier Extends Genetic Counseling Duty Of Care To Biological Mcclain Parents And Establishes That Legal Damages Must Occur Before A Wrongful Conception Action Accrues For Statute Of Limitations Purposes, Mark Hallberg, Teresa Fariss

William Mitchell Law Review

Inherited genetic disorders are a well-known cause of developmental delays in children. It is, therefore, “foreseeable” to physicians treating developmentally delayed children that parents of these children will rely on the physicians’ opinions of whether a genetic cause exists. Accordingly in 1992, when Dr. Diane Meier, a pediatrician, discovered developmental delays in S.F., the three-year-old daughter of Kimberly Flomer (now Molloy) and Robert Flomer, “accepted standards of pediatric practice” required Dr. Meier to order genetic testing, including testing for Fragile X Syndrome, one of the most common causes of inherited mental retardation. The foreseeable consequences of Dr. Meier’s alleged failure …

Raich, Health Care, And The Commerce Clause, Alex Kreit, Aaron Marcus

William Mitchell Law Review

This article considers to what extent health care may be viewed as a traditional area of state concern in the context of the Supreme Court’s revival of federalism principles, in particular limits on Congress’ Commerce Clause power, and what effect Raich v. Ashcroft, heard by the Court in the fall 2004 term, might have on these issues. Addressing these questions will necessarily involve exploration of medical marijuana policy as well as the role of the “traditional state interest” principle within the Commerce Clause. However, the central focus of this article is not what impact Raich may have on the Commerce …

World News, Blase Kornacki, Abby Okrent, Jennifer Rohleder, Mauro Zinner

Sustainable Development Law & Policy

No abstract provided.

Note: Capping Noneconomic Damages In Medical Malpractice Suits Is Not The Panacea Of The “Medical Liability Crisis”, Melissa C. Gregory

William Mitchell Law Review

This note explores the history behind the rising costs of medical malpractice insurance rates and the responsive state legislative proposals to limit noneconomic damages. The current state of health care liability and the recent federal proposals that include caps on noneconomic damages are then discussed. This note analyzes the reasons why the federal government should not cap noneconomic damages, primarily because: (1) states are better able to regulate health care, (2) noneconomic damages are not the determinate cause of rising medical malpractice insurance rates, and (3) caps infringe on equal protection guarantees by limiting compensation of medical malpractice victims. This …

Note: Exclusive Licensing Of Dna Diagnostics: Is There A Negative Effect On Quantity And Quality Of Healthcare Delivery That Compels Nih Rulemaking?, Edward Weck

William Mitchell Law Review

This comment surveys the costs of deoxyribonucleic acid (DNA) diagnostic tests and argues in favor of non-exclusive licensing as a means to provide broad access to affordable DNA diagnostic testing. Part II provides background information on genetic testing, patenting genes as applied to genetic testing, the Bayh-Dole Act, and technology transfer. In addition, Part II summarizes academic commentary regarding the implications of exclusive licensing for biotechnology. Scholars propose a number of solutions, including expanding the experimental use exception. Part III details proposed rulemaking for DNA diagnostics. Part IV reviews anecdotal examples of genetic testing for breast cancer, hereditary hemochromatosis, and …

The End Of Azt Patent: A New Beginning Or Too Little Too Late?, Lindsay Frank

Public Interest Law Reporter

No abstract provided.

Weight-Loss Advertising Too Good To Be True: Are Manufacturers Or The Media To Blame?, Jodie Sopher

Cardozo Arts & Entertainment Law Journal

No abstract provided.

Obesity And The Struggle Within Ourselves, Maxwell Gregg Bloche

Georgetown Law Faculty Publications and Other Works

The author argues that we ought to treat our eating, exercise habits, and girth as personal matters, for the most part, but that law can and should make a contribution, as an ally of our longer-term will against our immediate cravings. Law can be our ally in this fashion without command-and-control intrusion into our private lives. Such intrusion is at odds with our core beliefs and unlikely to produce public health success. It is more likely to provoke popular backlash--one reason why some who stand to gain from our unhealthy dining choices try to cast government efforts to inform these …

Modern Bootlegging And The Prohibition On Fair Prices: Last Call For The Repeal Of Pharmaceutical Price Gouging, Luke W. Cleland

ExpressO

This article discusses the recent passage of the Medicare Prescription Drug, Modernization and Improvement Act of 2003, and the executive and judicial decisions affecting the ability of the general public to access foreign pharmaceutical markets. The article examines the recent actions taken by the U.S. government, explore various state movements within the United States aimed at reducing pharmaceutical drug prices, outline the process of pharmaceutical drug prices in foreign countries, and advocate for a workable integration of all available mechanisms to feasibly reduce prescription drug prices for the benefit of both U.S. consumers and U.S. drug companies. As avenues to …