Food and Drug Law Commons^™

Direct-To-Consumer Genetic Testing: Learning From The Past And Looking Toward The Future, Stephanie Bair

Faculty Scholarship

A decade after the complete sequencing of the human genome, we have seen a proliferation of genetic testing services marketed directly to the consumer and purporting to use genetic information to generate individualized health information. These tests have been subject to only minimal regulation, despite the fact that scientists and policymakers have serious concerns about both the clinical effectiveness of the tests and the safety of releasing certain types of health information to the public without the supervision of a health care professional. Proponents of minimal regulation argue that the tests allow for patient autonomy and privacy of genetic information, …

Prescription For Change: Third Circuit Diagnoses Pharmaceutical Sales Representatives As Exempt From Overtime Pay In Smith V. Johnson & Johnson, Brooke Burns

Villanova Law Review

The article presents information on the pharmaceutical companies manufacturing brand-name drugs and the issues related to pharmaceutical sales representative (PSR). The intensive sales training program, the exempt from overtime pay based on the U.S. Fair Labor Standards Act and the economic justice and security of low income group are discussed. The court decision of Smith v. Johnson & Johnson, white-collar exemptions and employee misclassification are also discussed.

Patents Vs. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both?, Yaniv Heled

Faculty Publications By Year

On March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act (BPCIA) as part of the Patient Protection and Affordable Care Act (also known as the Healthcare Bill). BPCIA sets up a framework for the approval of generic biologics and provides for up to 12.5 years of market exclusivity for FDA approved bio-pharmaceutical products. The exclusivity is intended to run in parallel and in addition to any patents that may apply to such approved bio-pharmaceutical products, which would also grant the developers of these products monopolies in the underlying technologies on which such bio-pharmaceutical products …

United States--Certain Measures Affecting Imports Of Poultry From China: The Fascinating Case That Wasn't, Donald H. Regan

Articles

US–Poultry (China) was the first Panel decision dealing with an origin-specific SPS measure, or with what the United States referred to as an ‘equivalence regime’. More specifically, it was the first instance in which the basis for the challenged measure was the claimed inability of the complainant country to enforce its own food-safety rules. Unfortunately, as the litigation developed, the very interesting novel issues raised by such a measure were not discussed. This essay discusses those novel issues – in particular, what sort of scientific justification or risk assessment should be required for a measure like this, and what SPS …

Beyond Nuremberg: A Critique Of Informed Consent In Third World Human Subject Research , Jacob Schuman

Journal of Law and Health

This Article discusses the history of informed consent, critically analyzes this principle, and suggests an alternative approach to informed consent. Part II explores the concept of informed consent, including its philosophical bases, its implementation through FDA regulations, and current proposals on how to protect the principle in drug testing conducted abroad. Part III performs a critical analysis of the principle of informed consent; first providing an empirical examination of the realities of Third World human subject research, and then questioning both the coherence of an abstract “right” to informed consent, as well as the possibility of truly autonomous “consent” to …

Use Patents, Carve-Outs, And Incentives — A New Battle In The Drug-Patent Wars, Arti K. Rai

Faculty Scholarship

The Hatch-Waxman Act of 1984 aims to strike a balance between the innovation incentives provided by patents and the greater consumer access provided by low-cost generic drugs. The legislation, which relies in part on an explicit link between the FDA drug approval process and the U.S. patent system, has been controversial, particularly because of the ways in which firms producing brand-name drugs have exploited that link to delay market entry of generics as long as possible. Voluminous scholarship has focused on so-called "pay-for-delay" settlements of patent litigation between brand name and generic firms.

In contrast, this Perspective uses the lens …

Disease-Branding And Drug-Mongering: Could Pharmaceutical Industry Promotional Practices Result In Tort Liability?, Jason S. Cetel

Student Works

No abstract provided.

Debating The Cause Of Health Disparities: Implications For Bioethics And Racial Equality, Dorothy E. Roberts

All Faculty Scholarship

No abstract provided.

The Biologics Price Competition And Innovation Act Of 2009: Legislative Imprudence, Patent Devaluation, And The False Start Of A Multi-Billion Dollar Industry, Brian F. Mcmahon

Kentucky Law Journal

No abstract provided.

Fda Accelerated Approval Program: Why Brake When You Can Get A Mandate?, Keren Frumkin

Keren F. Bisnauth

The FDA approval process is designed to ensure that the drugs released for public consumption are safe and effective. In 1992, the FDA implemented the Accelerated Approval process in order to expedite the approval of drugs to aid patients with life-threatening illnesses, who have little to gain from lengthy approval processes, and who cannot risk worsening health conditions. However, the questionable post-approval practices of drug manufacturers, coupled with the lax FDA enforcement of its required follow-up protocols have raised doubts as to the true value of expedited approval procedures, as well as an influx of drug recalls and lawsuits. In …

Mergers, Market Dominance And The Lundbeck Case, Herbert J. Hovenkamp

All Faculty Scholarship

In Lundbeck the Eighth Circuit affirmed a district court’s judgment that a merger involving the only two drugs approved for treating a serious heart condition in infants was lawful. Although the drugs treated the same condition they were not bioequivalents. The Eighth Circuit approved the district court’s conclusion that they had not been shown to be in the same relevant market.

Most mergers that are subject to challenge under the antitrust laws occur in markets that exhibit some degree of product differentiation. The Lundbeck case illustrates some of the problems that can arise when courts apply ideas derived from models …

The Transatlantic Gmo Dispute Against The European Communities: Some Preliminary Thoughts, David A. Wirth

David A. Wirth

Any day now, a World Trade Organization panel is expected to rule in a dispute between the U.S. and the EU concerning market access for genetically-engineered foods and crops. This piece, written before the release of the WTO panel's report, analyzes novel systemic issues concerning the impact of WTO law on regulatory design, at both the national and international levels, that are raised by this dispute. These include (1) the application of WTO disciplines to regulatory schemes that require prior governmental approval to protect the environment and public health from newly-introduced products and substances; (2) the role of precaution as …

Food Justice As Interracial Justice: Urban Farmers, Community Organizations And The Role Of Government In Oakland, California, Christopher J. Curran, Marc-Tizoc González

University of Miami Inter-American Law Review

No abstract provided.

Unanswered Questions Of A Minority People In International Law: A Comparative Study Between Southern Cameroons & South Sudan, Bernard Sama Mr

Bernard Sama

The month July of 2011 marked the birth of another nation in the World. The distressful journey of a minority people under the watchful eyes of the international community finally paid off with a new nation called the South Sudan . As I watched the South Sudanese celebrate independence on 9 July 2011, I was filled with joy as though they have finally landed. On a promising note, I read the UN Secretary General Ban Ki-moon saying “[t]ogether, we welcome the Republic of South Sudan to the community of nations. Together, we affirm our commitment to helping it meet its …

Revisiting The Original Tea Party: The History Of Regulating Food Consumption In America, Alison Peck

Law Faculty Scholarship

In response to concerns over rising obesity rates, state and federal policymakers have introduced laws that seek to internalize the public health costs of consuming unhealthy foods. These laws range from taxes on sugared beverages to mandatory nutritional information disclosures and beyond. Vocal opponents to such laws, including many Tea Party members, characterize such laws as government overreaching into the private sphere. That opposition often evokes Revolutionary images and ideology, with references to the Boston Tea Party, the Founding Fathers, and the framing of the Constitution. This article challenges the symbolism used by these opponents by examining the pre-Revolutionary non-importation …

The Kingpin Act Vs. California's Compassionate Use Act: The Dubious Battle Between State And Federal Drug Laws, Sumeet H. Chugani, Xingjian Zhao

University of the District of Columbia Law Review

No abstract provided.

The Politics Of Exclusion In California's Marijuana Reform Movement, Brooke Mascagni

University of the District of Columbia Law Review

No abstract provided.

A Decade After Drug Decriminalization: What Can The United States Learn From The Portuguese Model?, Jordan Blair Woods

University of the District of Columbia Law Review

No abstract provided.

Rise Of The Pills, Ken Lammers Jr.

University of the District of Columbia Law Review

No abstract provided.

Again And Again We Suffer: The Poor And The Endurance Of The "War On Drugs", Brian Gilmore

University of the District of Columbia Law Review

No abstract provided.