The Future of Generic Biologics: Should the United States “Follow-On” the European Pathway?

By: Ingrid Kaldre The United States is embarking on a biotechnology drug revolution. In the last few decades, biotech drugs have saved millions of lives, and the market for these miracle cures continues to grow at an astronomical rate. Unfortunately, as the market for biotech drugs is skyrocketing, drug prices are following suit. As Congress strives to make these new drugs more affordable, it must not ignore significant safety concerns unique to these revolutionary therapies. Congress should follow the lead of the European Union to create an accessible pathway for generic forms of biotech drugs that includes strict regulatory measures to ensure drug safety and efficacy. Download Full Article (PDF) Cite: 2008 Duke L. & Tech. Rev. 0009

McKithen v. Brown: Due Process and Post-Conviction DNA Testing

By: Elizabeth A. Laughton When the Second Circuit decided McKithen v. Brown, it joined an ever-growing list of courts faced with a difficult and pressing issue of both constitutional and criminal law: is there a federal constitutional right of post-conviction access to evidence for DNA testing? This issue, which sits at the intersection of new forensic technologies and fundamental principles of constitutional due process, has divided the courts. The Second Circuit, wary of reaching a hasty conclusion, remanded McKithen’s case to the district court for consideration. The district court for the Eastern District of New York was asked to decide whether a constitutional right of access to evidence for DNA testing exists both broadly as well as under the defendant’s circumstances. This iBrief concludes that although a due process post-conviction right of access to evidence for DNA testing may exist under some circumstances, it does not exist under current constitutional jurisprudence in McKithen’s case. Download Full Article (PDF) Cite: 2008 Duke L. & Tech. Rev. 0007

Regulating Nanotechnology: A Private–Public Insurance Solution

By: Maksim Rakhlin Nanotechnology promises to revolutionize innovation in nearly every industry. However, nanomaterials’ novel properties pose potentially significant health and environmental risks. Views in the current debate over nanotechnology regulation range from halting all research and development to allowing virtually unregulated innovation. One viable regulatory solution balancing commercialization and risk is the adoption of a mandatory private-public insurance program. Download Full Article (PDF) Cite: 2008 Duke L. & Tech. Rev. 0002

Why Technology Provides Compelling Reasons to Apply a Daubert Analysis to the Legal Standard of Care in Medical Malpractice Cases

By: Nichole Hines Traditionally, courts have applied a “customary practice” standard in determining the legal standard of care in medical malpractice cases. Recently, a few courts have abandoned this dated standard and instead applied a Daubert analysis to the standard of care, which focuses on medical evidence that is scientifically based . In light of these recent holdings, this iBrief argues that with the increasing amounts of technologies improving evidence-based medicine, the customary practice standard is no longer a useful or appropriate test for determining the standard of care in medical malpractice cases. By applying a Daubert analysis to an expert’s testimony on the standard of care, the testimony becomes a scientifically based testimony rather than an expert’s notion of what is common practice in the medical profession. Download Full Article (PDF) Cite: 2006 Duke L. & Tech. Rev. 0018

What, if Any, Are the Ethical Obligations of the U.S. Patent Office? A Closer Look at the Biological Sampling of Indigenous Groups

By: Marina L. Whelan The patenting of biological resources collected from indigenous groups has become a controversial trend. Two U.S. patents in particular, one claiming a cell-line from a 26-year old Guayami woman and one claiming a leukemia virus from a Hagahai man in Papua New Guinea, demonstrate just how volatile this issue has become. This iBrief examines how, in light of such “ethically questionable” patents, the U.S. Patent Office has failed to implement any procedures to identify or curb patent applications involving indigenous peoples. Download Full Article (PDF) Cite: 2006 Duke L. & Tech. Rev. 0014

Attack of the Clones: Legislative Approaches to Human Cloning in the United States

By: Adrienne N. Cash The legal concerns involving the application of cloning technology to humans should be of utmost concern, as the area is extremely complex. Cloning could potentially have great benefits or disastrous effects. Lawmakers have been careful to make certain that the legislation passed is comprehensive and useful for regulation of the ever-changing field of cloning. From debates on whether reproductive or therapeutic cloning should be permitted or banned, to concerns as to who has jurisdiction over cloning, the battle to develop cloning legislation has been difficult. However, this iBrief argues that the currently-proposed federal legislation is constitutional. Download Full Article (PDF) Cite: 2005 Duke L. & Tech. Rev. 0026

When the Public Does Not Have a Right to Know: How the California Public Records Act Is Deterring Bioscience Research and Development

By: Nader Mousavi & Matthew J. Kleiman Many bioscience firms collaborate with public research universities to conduct innovative research through sponsored research agreements. Companies sponsoring this research usually require strict confidentiality from their academic partners in order to protect sensitive information that, if revealed, could put them at a competitive disadvantage and threaten their ability to obtain future patents. Yet, ambiguous disclosure requirements in the California Public Records Act preclude California’s public research universities from guaranteeing that proprietary information provided in connection with sponsored research agreements will remain confidential. Entering into such agreements with public universities in California is therefore a risky proposition for the sponsors. This iBrief argues that unless this is corrected, many of these public/private partnerships, which often lead to significant advances in science and medicine, may be deterred. Download Full Article (PDF) Cite: 2005 Duke L. & Tech. Rev. 0023

Taking Biologics for Granted? Takings, Trade Secrets, and Off-Patent Biological Products

By: Andrew Wasson Biologics are complex medicines which are often genetically engineered, and which are sure to play an important role in curing some of humankind’s worst diseases. Not surprisingly, generic companies want a part of the biologic market. The FDA believes that it has the authority to approve off-patent versions of biologics that were originally regulated under the Food, Drug & Cosmetic Act, but in order to effectively do so the FDA would have to rely on findings based on data produced by the brand name companies. This iBrief examines whether the FDA’s reliance on previous findings would give rise to a valid claim under the Takings Clause of the U.S. Constitution. In the end, it concludes that the FDA’s proposed action likely would not constitute a taking. Download Full Article (PDF) Cite: 2005 Duke L. & Tech. Rev. 0004

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