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Articles 61 - 89 of 89
Full-Text Articles in Law
Taking Biologics For Granted? Takings, Trade Secrets, And Off-Patent Biological Products, Andrew Wasson
Taking Biologics For Granted? Takings, Trade Secrets, And Off-Patent Biological Products, Andrew Wasson
Duke Law & Technology Review
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 …
Disclosure Of Clinical Trial Data: Why Exemption 4 Of The Freedom Of Information Act Should Be Restored, Janene Boyce
Disclosure Of Clinical Trial Data: Why Exemption 4 Of The Freedom Of Information Act Should Be Restored, Janene Boyce
Duke Law & Technology Review
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 …
Regulating Innovative Medicine: Fitting Square Pegs In Round Holes, Mark Lavender
Regulating Innovative Medicine: Fitting Square Pegs In Round Holes, Mark Lavender
Duke Law & Technology Review
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 …
Against “Individual Risk”: A Sympathetic Critique Of Risk Assessment, Matthew D. Adler
Against “Individual Risk”: A Sympathetic Critique Of Risk Assessment, Matthew D. Adler
Faculty Scholarship
No abstract provided.
The Medicare Prescription Drug, Improvement, & Modernization Act Of 2003: Are We Playing The Lottery With Healthcare Reform?, Melissa Ganz
The Medicare Prescription Drug, Improvement, & Modernization Act Of 2003: Are We Playing The Lottery With Healthcare Reform?, Melissa Ganz
Duke Law & Technology Review
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.
Politics, Power, And Public Health: A Comment On Public Health’S New World Order, Laurence R. Helfer
Politics, Power, And Public Health: A Comment On Public Health’S New World Order, Laurence R. Helfer
Faculty Scholarship
No abstract provided.
Are Biotech Crops And Conventional Crops Like Products? An Analysis Under Gatt, Julian Wong
Are Biotech Crops And Conventional Crops Like Products? An Analysis Under Gatt, Julian Wong
Duke Law & Technology Review
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 …
Hatch–Waxman Reform And Accelerated Market Entry Of Generic Drugs: Is Faster Necessarily Better?, Sarah E. Eurek
Hatch–Waxman Reform And Accelerated Market Entry Of Generic Drugs: Is Faster Necessarily Better?, Sarah E. Eurek
Duke Law & Technology Review
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 …
Reviving Informed Consent: Using Risk Perception In Clinical Trials, Dana Ziker
Reviving Informed Consent: Using Risk Perception In Clinical Trials, Dana Ziker
Duke Law & Technology Review
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.
The Case For National Dna Identification Cards, Ben Quarmby
The Case For National Dna Identification Cards, Ben Quarmby
Duke Law & Technology Review
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 …
Defining A New Ethical Standard For Human In Vitro Embryos In The Context Of Stem Cell Research, Sina A. Muscati
Defining A New Ethical Standard For Human In Vitro Embryos In The Context Of Stem Cell Research, Sina A. Muscati
Duke Law & Technology Review
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 …
Regulating Functional Foods: Pre- And Post-Market Strategy, Dana Ziker
Regulating Functional Foods: Pre- And Post-Market Strategy, Dana Ziker
Duke Law & Technology Review
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.
Genetic Testing In The Workplace: The Employer’S Coin Toss, Samantha French
Genetic Testing In The Workplace: The Employer’S Coin Toss, Samantha French
Duke Law & Technology Review
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 …
Customizing Conception: A Survey Of Preimplantation Genetic Diagnosis And The Resulting Social, Ethical, And Legal Dilemmas, Jason Christopher Roberts
Customizing Conception: A Survey Of Preimplantation Genetic Diagnosis And The Resulting Social, Ethical, And Legal Dilemmas, Jason Christopher Roberts
Duke Law & Technology Review
One in six American couples experience difficulties conceiving a child. With fertility rates at an all time low, the business of treating infertility is booming. However, due to the United States prohibition on government funding for embryonic research, the $4 billion industry of assisted reproductive technologies (ART) has been incompletely monitored and largely removed from oversight. Additionally, due to the fervent abortion debate, in vitro fertilization (IVF) was introduced in the United States without a research phase and procedures have been forced to evolve in the private sector. Thus, the checks and balances on medical innovation that are generally imposed …
Appropriate Aims: Setting Boundaries For Reprogenetic Technology, Dana Ziker
Appropriate Aims: Setting Boundaries For Reprogenetic Technology, Dana Ziker
Duke Law & Technology Review
Not too long ago, ten fingers and ten toes defined a successful birth. Not too far from now, ten fingers and ten toes will be just the beginning. Parents always hope for a healthy baby, and medical advances continue to help secure the fulfillment of this hope. But reprogenetics, a new combination of technology and science that allows us to choose the genes, and thus the traits, of the children we create, is raising new questions about what it means to have a healthy baby.
Egregious Error Or Admirable Advance: The Memorandum Of Understanding That Enables Federally Funded Basic Human Embryonic Stem Cell Research, Amy Ligler
Duke Law & Technology Review
Nothing contained herein shall be considered to be the grant of a commercial license or right under the Wisconsin Patent Rights or to Wisconsin Materials. Furthermore, nothing contained herein shall be construed to be a waiver of WiCell's patent rights under the Wisconsin Patent Rights or WiCell's property rights in Wisconsin Materials.
A Reconsideration Of The Physicians’ Immunity Statute, Steve Dirksen
A Reconsideration Of The Physicians’ Immunity Statute, Steve Dirksen
Duke Law & Technology Review
The author assesses the "physicians' immunity statute" from legal policy, ethical, and financial perspectives, and concludes that alternatives such as licensure and monetary incentives would better serve the goal of encouraging invention more effectively by rewarding it.
The Clone Wars: The Growing Debate Over Federal Cloning Legislation, John Garvish
The Clone Wars: The Growing Debate Over Federal Cloning Legislation, John Garvish
Duke Law & Technology Review
As readers of science fiction are well aware, the term "clone" refers to asexually produced offspring, that is, offspring produced by a process of cell-division which does not begin with the union of two sex cells. A clone is the genetic twin of the cell donor. Propagation of plants by this method is, of course, commonplace, but mammalian reproduction in this fashion would indeed be a revolutionary accomplishment, with profound and disturbing implications.
Where The Wild Wind Blows: Genetically Altered Seed And Neighboring Farmers, Jill Sudduth
Where The Wild Wind Blows: Genetically Altered Seed And Neighboring Farmers, Jill Sudduth
Duke Law & Technology Review
In March 2001, agro-business giant Monsanto won a victory in Canadian Federal Court over Saskatchewan farmer Percy Schmeiser. This case sets international precedent for appropriated seed cases and illustrates the primary concerns American courts must face as they consider Monsanto's prosecution of 22 cases against American farmers.
The Fate Of Gene Patents Under The New Utility Guidelines
The Fate Of Gene Patents Under The New Utility Guidelines
Duke Law & Technology Review
The United States Patent and Trademark Office (PTO) recently finalized its patent utility guidelines. Promulgated by the PTO, the new guidelines will be used by patent examiners in determining whether a claimed invention should be awarded patent protection ;and will be used by patent applicants and attorneys who file patent applications. The guidelines focus primarily on the utility standards for gene and gene fragment patents, an issue that was featured in the PTO's 1999 Revised Interim Utility Guidelines and has been the subject of considerable public debate.
Health Care Fraud And Abuse: A Tale Of Behavior Induced By Payment Structure, Arti K. Rai
Health Care Fraud And Abuse: A Tale Of Behavior Induced By Payment Structure, Arti K. Rai
Faculty Scholarship
The campaign to curtail "fraud and abuse" in the Medicare and Medicaid programs represents an attempt by regulators to evade more fundamental and difficult questions regarding cost and quality control. In the Medicare arena, tackling these larger questions will require dismantling the program's fee-for-service structure and imposing on providers financial incentives to evaluate carefully health care costs and benefits. Commentary on, David A. Hyman, Health Care Fraud and Abuse: Market Change, Social Norms and the Trust "Reposed in Workmen," 30 Journal of Legal Studies 531 (2001)
An Overview Of Health Law Research And An Annotated Bibliography, Richard A. Danner, Claire M. Germain
An Overview Of Health Law Research And An Annotated Bibliography, Richard A. Danner, Claire M. Germain
Faculty Scholarship
No abstract provided.
Foreword: Public And Private Barriers To Competitive Reform Of Health Care Services Delivery, Clark C. Havighurst
Foreword: Public And Private Barriers To Competitive Reform Of Health Care Services Delivery, Clark C. Havighurst
Faculty Scholarship
No abstract provided.
Private Credentialing Of Health Care Personnel: An Antitrust Perspective, Part 1, Clark C. Havighurst, Nancy M. P. King
Private Credentialing Of Health Care Personnel: An Antitrust Perspective, Part 1, Clark C. Havighurst, Nancy M. P. King
Faculty Scholarship
This Article explores the antitrust and other implications of private credentialing and accrediting programs in the health care industry. Although such programs are usually sponsored by powerful competitor groups, they serve the procompetitive purpose of providing useful information and authoritative advice to independent decision makers. Part One examines the risk that credentialing will sometimes be unfair to competitors and deceive consumers. Its survey of common-law, antitrust, and regulatory interventions to correct such unfairness and deception seeks to determine the degree of oversight to which credentialing and similar activities have been and should be subjected. In recommending that judicial or regulatory …
Private Credentialing Of Health Care Personnel: An Antitrust Perspective, Part 2, Clark C. Havighurst, Nancy M. P. King
Private Credentialing Of Health Care Personnel: An Antitrust Perspective, Part 2, Clark C. Havighurst, Nancy M. P. King
Faculty Scholarship
Having argued in Part One against extensive judicial or regulatory interference with private personnel credentialing in the health care field, this Article now shifts its focus to emphasize the anticompetitive hazards inherent in credentialing as practiced by professional interests. Competitor-sponsored credentialing is shown to be a vital part of a larger cartel strategy to curb competition by standardizing personnel and services and controlling the flow of information to health care consumers. Instead of altering the conclusions reached in Part One, however, Part Two sets forth a new and hitherto unexplored agenda for antitrust enforcement, one that the authors believe will …
Foreword: Symposium On Hospital Law, Clark C. Havighurst
Foreword: Symposium On Hospital Law, Clark C. Havighurst
Faculty Scholarship
No abstract provided.
Health Planning And Antitrust Law: The Implied Amendment Doctrine Of The Rex Hospital Case, Clark C. Havighurst
Health Planning And Antitrust Law: The Implied Amendment Doctrine Of The Rex Hospital Case, Clark C. Havighurst
Faculty Scholarship
No abstract provided.
More On Regulation: A Reply To Stephen Weiner, Clark C. Havighurst
More On Regulation: A Reply To Stephen Weiner, Clark C. Havighurst
Faculty Scholarship
In Volume 3, Number 3 of this journal, Professor Havighurst* wrote a brief Comment in which he observed that the function of health care cost-containment regulation is the rationing of health care resources, and argued that the fostering of health care consumers' and providers' free choice in the competitive marketplace is preferable to conventional cost-containment regulation as a mechanism for such rationing. He briefly outlined various reforms, including changes in federal tax treatment of health insurance premiums, aimed at implementing his ap- proach. Subsequently, in a Comment in Volume 4, Number 1, Stephen M.Weiner, then Chairman of the Massachusetts Rate …
Health Care Cost-Containment Regulation: Prospects And An Alternative, Clark C. Havighurst
Health Care Cost-Containment Regulation: Prospects And An Alternative, Clark C. Havighurst
Faculty Scholarship
Regulation of the health care system to achieve appropriate containment of overall costs is characterized by Professor Havighurst as requiring public officials to engage, directly or indirectly, in the rationing of medical services. This rationing function is seen by the author as peculiarly difficult for political institutions to perform, given the public's expectations and the symbolic importance of health care. An effort on the part of regulators to shift the rationing burden to providers is detected, as is a trend toward increasingly arbitrary regulation, designed to minimize regulators' confrontations with sensitive issues. Irrationality and ignorance are found to plague regulatory …