Food and Drug Law Commons^™

Pharmacy Compounding After The Drug Quality And Security Act, Erika Lietzan

Faculty Publications

On November 27, 2013, President Obama signed into law the Drug Quality and Security Act ("DQSA"), which amends the Federal Food, Drug, and Cosmetic Act ("FDCA") to add statutory provisions addressing drug compounding and supply chain issues. This article discusses Title I of this legislation, known as the Compounding Quality Act, and draft compounding guidances subsequently issued by the Food and Drug Administration ("FDA"). Section I provides a brief history of FDA's regulation of compounding activities before the Compounding Quality Act's enactment. Section II reviews the Compounding Quality Act and FDA's new draft guidances. Section III considers some of the …

Spring 2014 Utton Center Newsletter, Utton Center, University Of New Mexico - School Of Law

Publications

No abstract provided.

Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski

Journal Articles

All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research and …

Unequal Protection Under The Law: Why Fda Should Use Negotiated Rulemaking To Reform The Regulation Of Generic Drugs, Marie Boyd

Cardozo Law Review

The duty to ensure the safety of drug products, through adequate warnings or other means, should ultimately rest with the drug's manufacturer regardless of whether the drug is a generic drug or a brand-name drug. Recent U.S. Supreme Court holdings, however, suggest that while the manufacturer of a brand-name drug is always responsible for its label's content, this is not the case for generic drugs. In addition, by holding that failure-to-warn claims against generic drug manufacturers based on state law are preempted, the Court has removed the protections and compensation that state tort law can provide consumers of generic drugs …

Depicting The Graphic Truth: The Heated Controversy Over Cigarette Warning Labels And The Boundaries Of First Amendment Protection, Brian Fedele

Cardozo Public Law, Policy & Ethics Journal

No abstract provided.

Failing To Warn In The Context Of Rare Side Effects, Morris Dweck

Cardozo Public Law, Policy & Ethics Journal

No abstract provided.

The Rise Of Transnational Private Meta-Regulators, Paul Verbruggen, Tetty Havinga

Transnational Business Governance Interactions Working Papers

In recent years scholars from various disciplines have turned their attention to transnational regimes of regulation that are chiefly developed outside state-driven frameworks. The rise of such "transnational private regulation" has also led to the emergence of private meta-regulation. The term 'meta-regulation' commonly refers to processes through which a regulatory body oversees another and sets standards for its activities or performance of regulation. In the public domain, meta-regulation has been associated with the devolution of regulatory activities by a statutory body to private actors with the view to enhance voluntary rule compliance, awareness of responsibilities among the regulated and reduce …

"Natural" Food Labeling: False Advertising And The First Amendment

Marquette Elder's Advisor

No abstract provided.

Dietary Supplement Labeling: Cognitive Biases, Market Manipulation & Consumer Choice, Michael Mccann

Law Faculty Scholarship

There exists increasing concern that the Dietary Supplements Health and Education Act (DSHEA) has proven ineffective. Much of the concern regards the disparity in legislative treatment between dietary supplements, foods, and pharmaceutical drugs. Namely, while pharmaceutical drugs must undergo years of costly pre-market testing, most supplements, like foods, can immediately enter the market, and only after repeated instances of adverse reactions can the Food and Drug Administration (FDA) remove them. Such a framework appears to belie both consumer expectations and marketing strategies, as supplements tend to be most perceived for their apparent medicinal qualities. This philosophy of waiting for a …

Making Do In Making Drugs: Innovation Policy And Pharmaceutical Manufacturing, W. Nicholson Price Ii

Law Faculty Scholarship

Despite increasing recalls, contamination events, and shortages, drug companies continue to rely on outdated manufacturing plants and processes. Drug manufacturing’s inefficiency and lack of innovation stand in stark contrast to drug discovery, which is the focus of a calibrated innovation policy that combines patents and FDA regulation. Pharmaceutical manufacturing lags far behind the innovative techniques found in other industries due to high regulatory barriers and ineffective intellectual property incentives. Among other challenges, although manufacturers tend to rely on trade secrecy because of the difficulty in enforcing patents on manufacturing processes, trade secrecy provides limited incentives for innovation. To increase those …

Squashing The Superbugs: A Proposed Multifaceted Approach To Combatting Antibiotic-Resistant Bacteria , Lauren Orrico

Journal of Law and Health

Section II of this Note will provide background on the practices of the United States farming system, which fosters the creation of antibiotic-resistant bacteria. This section will also provide background on the detrimental effects that antibiotic resistance has on human health and will briefly describe the legal history of food and drug regulations. After establishing an informational foundation, Part III will elaborate on current laws and describe the legal authority of key players, before pointing out the shortcomings in current animal feed policy and recommending the development of further regulation in this area. Additionally, Part III will propose new legislation …

Food Art: Protecting "Food Presentation" Under U.S. Intellectual Property Law, 14 J. Marshall Rev. Intell. Prop. L. 1 (2014), Cathay Smith

UIC Review of Intellectual Property Law

In 2006, a scandal broke in the culinary world. It was alleged that Robin Wickens, chef at (now closed) Interlude restaurant in Melbourne, Australia, had copied dishes by renowned American chefs Wylie Dufresne, Jose Andres, and Grant Achatz. It is not uncommon for chefs to borrow recipes from other chefs, and there has been a long culture of sharing in the cuisine industry. However, what made Wickens’ actions scandalous was that he had purportedly copied the artistic presentation and plating of other chefs’ dishes, not just their recipes.

This Article examines whether chefs can protect the artistic presentation or plating …

3(D) View Of India’S Patent Law: Social Justice Aspiration Meets Property Rights In Novartis V. Union Of India & Others, 13 J. Marshall Rev. Intell. Prop. L. 719 (2014), Saby Ghoshray

UIC Review of Intellectual Property Law

Not many constitutional decisions from developing countries find themselves at the center of global debate like the Indian Supreme Court’s Novartis decision invalidating the Gleevec patent. The patent was invalidated under amended Section 3(d) of the Indian Patents Act, which was amended to address some of the concerns of imbalance between the maximalist and minimalist cultures in the pharmaceutical context. Section 3(d) of the Indian Patent Act introduced a new threshold of patent eligibility for pharmaceutical innovation that requires applicants to demonstrate enhanced efficacy of their products. The objective of this Article is to get beyond the reactionary reviews of …

Morning-After Decisions: Legal Mobilization Against Emergency Contraception In Chile, Fernando Muñoz León

Michigan Journal of Gender & Law

In Chile, the Criminal Code bans all forms of abortion. Furthermore, the Constitution—drafted and enacted by the Military Junta led by General Augusto Pinochet—was inspired by a conservative version of Catholic natural law championed by prominent Chilean constitutional law scholars. This Article traces the emergence, development, and ultimately the defeat of a persistent legal mobilization driven by natural law-inspired litigants, politicians, and scholars against levonorgestrel-based emergency contraception, also known as the morning-after pill. In their decade-long efforts at legal mobilization, these natural law litigants used every tool of the Chilean legal system to challenge the legality and the constitutionality of …

Food Miles: Environmental Protection Or Veiled Protectionism?, Meredith Kolsky Lewis, Andrew D. Mitchell

Michigan Journal of International Law

Eat local. Such a small phrase yet such a loaded proposition. Buying food from nearby sources has become a popular objective. This aim is associated with helping farmers in one’s country or region; observing the seasonality of one’s location; eating fresher foods; striving for food security; and protecting the environment. One of the unmistakable messages of the “locavore” movement is that importing food—particularly food that comes from far away—causes environmental harm. The theory is that transporting food long distances results in the release of high levels of greenhouse gases (GHGs) into the atmosphere and is thus a dangerous contributor to …

The Penumbra Of The United States’
 Foreign Corrupt Practices Act: Brazil’S Clean Companies Act And 
Implications For The Pharmaceutical
 Industry, Beverley Earle, Anita Cava

Richmond Journal of Global Law & Business

No abstract provided.

Who Can Afford It?: The Patient Protection And Affordable Care Act's Failure To Regulate Excessive Cost-Sharing Of Prescription Biologic Drugs , Michael Callam

Journal of Law and Health

This Note will discuss how the PPACA’s abbreviated approval pathway for biological products creates an expedited procedure to bring less expensive biologic drugs to the market, but ultimately fails to make those biologic drugs affordable because of its lack of provisions limiting insurers’ use of excessive cost-sharing requirements. Part II provides an overview of prescription drugs, compares biologics with traditional prescription drugs, and provides a brief legislative history of prescription drug laws. Part III analyzes the impact of the abbreviated approval pathway on biologic drugs’ costs to prescribed patients. It also examines the PPACA’s effects on biologics inclusion into health …

Smoking Out A Compromise: Splitting The Difference Through A Public Policy Approach To Resolving The Graphic Cigarette Warning Label Circuit Split, Amelia B. Larsen

Cleveland State Law Review

The imposition of graphic warning labels is necessary; the tobacco market exploits the lower class by capitalizing on their under-education regarding the negative health consequences of smoking. This injustice can be corrected by providing the most direct and clear communication imaginable to consumers to ensure they are completely informed of the peril they are placing themselves in when they choose to smoke—the graphic warning labels provide this kind of communication. This Note discusses why the FDA’s warning labels meet First Amendment constitutional scrutiny and serve a substantial governmental interest regarding the country’s public health, socioeconomic equality, and economy. Part II …

Greenwashing And Self-Declared Seafood Ecolabels, Jason J. Czarnezki

Elisabeth Haub School of Law Faculty Publications

The credibility and veracity of an environmental claim depends on a high degree of transparency, clarity, and trust. Businesses that utilize ecolabels to market the environmental performance of their seafood products often turn to third-party certifications to minimize the potential for greenwashing and provide a level of verification and independence. Others rely on a riskier approach by developing their own self-declared or first-party ecolabels. Seafood retailers and suppliers considering the creation and use of an ecolabel, certification, or seal to be used in the marketing of seafood products should ensure compliance with applicable Food and Drug Administration and United States …

Bad Medicine: Ftc V. Actavis, Inc. And The Missed Opportunity To Resolve The Pay-For-Delay Problem, Susan Schipper

Maryland Law Review

No abstract provided.