Disclosure of Clinical Trial Data: Why Exemption 4 of the Freedom of Information Act Should Be Restored

By: Janene Boyce Clinical trial data generated during the FDA drug approval process can be very valuable. While patients and doctors desperately need this information to make informed choices about medical treatment, drug sponsors strive to keep this resource secret to ensure their ability to profit from their own research. In the wake of the controversy over antidepressant use in children, both the public and Congress have called for the disclosure of all clinical trial data. However, rather than taking an all-or-nothing approach that could harm the development of new drugs, this iBrief argues that Congress should address the issue of trial data disclosure by restoring the proper balance to Exemption 4 of the Freedom of Information Act. Download Full Article (PDF) Cite: 2005 Duke L. & Tech. Rev. 0003

Regulating Innovative Medicine: Fitting Square Pegs in Round Holes

By: Mark Lavender Increasingly, innovative medical products are creating a quandary for the Food and Drug Administration (“FDA”) because they often transcend the FDA’s traditional categorical approach to regulating medical products. In a recent attempt to simplify this process, the FDA has proposed a new rule for regulating “combination products.” This iBrief discusses the FDA’s current approach and analyzes the possible affects of the proposed regulation. Because of the many shortcomings of both systems, this iBrief concludes that the FDA should instead stop assigning center jurisdiction based on a product’s “primary mode of action,” and give the Office of Combination Products internal agency jurisdiction over combination products. This alternative approach would increase consistency and efficiency while maintaining the FDA’s high standards for medical product safety and efficacy. Download Full Article (PDF) Cite: 2005 Duke L. & Tech. Rev. 0001

The Medicare Prescription Drug, Improvement, & Modernization Act of 2003: Are We Playing the Lottery With Healthcare Reform?

By: Melissa Ganz With millions of Americans unable to cope with the rising costs of prescription drugs, and many even forced to go without health insurance, the mounting pressure on Congress to enact major healthcare reform culminated in the Medicare Prescription Drug, Improvement, & Modernization Act of 2003. This iBrief examines this legislation, and concludes that it provides elusive benefits for seniors and merely creates a windfall for the pharmaceutical and insurance industries. Download Full Article (PDF) Cite: 2004 Duke L. & Tech. Rev. 0011

Are Biotech Crops and Conventional Crops Like Products? An Analysis Under GATT

By: Julian Wong The transatlantic debate over the use of genetically modified organisms (“GMO”s) as food products, with the US as a proponent on one side, and the European Union (“EU”) as an opponent on the other, is set to take center stage. The US has initiated formal legal action under the World Trade Organization Dispute Settlement System, charging that the EU violates several agreements of international trade law, including Article III of GATT, an anti-protectionist measure which forbids a country from favoring its own products over imported “like products.” The US claims that GMOs and conventional crops are “like products,, and that the EU moratorium on GMOs thus violates Article III. This iBrief assesses the US “like products” claim, most notably in light of Asbestos, a recent WTO case which provides important guidance for determining likeness under four criteria. Download Full Article (PDF) Cite: 2003 Duke L. & Tech. Rev. 0027

Hatch–Waxman Reform and Accelerated Market Entry of Generic Drugs: Is Faster Necessarily Better?

By: Sarah E. Eurek Recently there has been a considerable amount of pressure to accelerate consumer access to generic drugs, which are significantly less expensive than their brand-name counterparts. One way to bring generic drugs on to the market sooner is through revision of the existing law relating to pharmaceutical patents. This iBrief describes recent regulatory changes to the Drug Price Competition and Patent Term Restoration Act (the Hatch-Waxman Act), which governs the patenting process for new drug products, as well as current legislative efforts to speed generic access through Hatch-Waxman reform. This iBrief also assesses whether these changes will be beneficial to consumers on a long-term basis. Download Full Article (PDF) Cite: 2003 Duke L. & Tech. Rev. 0018

Reviving Informed Consent: Using Risk Perception in Clinical Trials

By: Dana Ziker The current doctrine of informed consent falls far short of its potential to serve as a valuable safeguard for human research subjects. Instead of providing a channel of communication between physician and subject, informed consent is a lifeless entity responsible for a large portion of the misunderstanding existing between these parties. Acknowledging risk perception principles may help transform the informed consent process into an effective communication of health risks. Download Full Article (PDF) Cite: 2003 Duke L. & Tech. Rev. 0015

The Case for National DNA Identification Cards

By: Ben Quarmby Foes of the United States have demonstrated their ability to strike at the heart of this country. Fear of renewed attacks and a desire for greater national security have now prompted many to call for improvements in the national personal identification system. In particular, the possibility of a national identification card containing the carrier’s DNA information is being seriously considered. However, this raises difficult questions. Would such a card system, and the extraction of individuals’ DNA it entails, violate the 4th Amendment of the Constitution? This article will show that such a card system could in fact be found to be constitutional under the law of privacy as it stands today. Download Full Article (PDF) Cite: 2003 Duke L. & Tech. Rev. 0002

Defining a New Ethical Standard for Human in Vitro Embryos in the Context of Stem Cell Research

By: Sina A. Muscati This iBrief discusses some of the social, ethical and legal considerations surrounding the use of unimplanted, in vitro embryos in stem cell research. It proposes that a new ethical standard be elucidated for these embryos. The iBrief gives an overview of two proposals for such a standard at opposite ends of the spectrum: treating the in vitro embryo as a legal person versus treating it as mere property. It argues against both approaches. The former can have undesirable social implications including undue interference with female reproductive autonomy, while the latter would objectify potential human life and reproductive potential. The iBrief proposes an intermediate approach that treats the embryo as a special entity. It warns against a model whereby the respect accorded to embryos is made dependent on the attainment of various qualitative or developmental criteria. The complexities surrounding human life, it argues, are too uncertain. What is certain is the embryo’s unique potential for human life, at any developmental stage. This, the iBrief proposes, should be the sole criterion for an embryo’s special status, a status that should be confined within constitutional limits. Download Full Article (PDF) Cite: 2002 Duke L. & Tech. Rev. 0026

Regulating Functional Foods: Pre- and Post-Market Strategy

By: Dana Ziker As best we understand the government, its first argument runs along the following lines: that health claims lacking “significant scientific agreement” are inherently misleading because they have such an awesome impact on consumers as to make it virtually impossible for them to exercise any judgment at the point of sale. It would be as if the consumers were asked to buy something while hypnotized, and therefore they are bound to be misled. We think this contention is almost frivolous. Download Full Article (PDF) Cite: 2002 Duke L. & Tech. Rev. 0024

Genetic Testing in the Workplace: The Employer’s Coin Toss

By: Samantha French A toss of the coin by the modern-day employer reveals two options regarding genetic testing in the workplace. The employer may choose to take advantage of increasingly precise, available, and affordable genetic testing in order to ascertain the genetic characteristics – and deficiencies – of its employees. This outcome exposes the employer to a vast array of potential litigation and liability relating to the Americans with Disabilities Act, the Fourth Amendment, Title VII of the Civil Rights Act, and state legislation designed to protect genetic privacy.  Alternatively, the employer may neglect to indulge in this trend of genetic testing and may face liability for employer negligence, violations of federal legislation such as OSHA regulations, and increased costs associated with insuring the health of genetically endangered employees. In the rapidly developing universe of genetic intelligence, the employer is faced with a staggering dilemma. Download Full Article (PDF) Cite: 2002 Duke L. & Tech. Rev. 0015