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Articles 181 - 210 of 240
Full-Text Articles in Law
Refusal To Dispense Emergency Contraception In Washington State: An Act Of Conscience Or Unlawful Sex Discrimination?, Dana E. Blackman
Refusal To Dispense Emergency Contraception In Washington State: An Act Of Conscience Or Unlawful Sex Discrimination?, Dana E. Blackman
Michigan Journal of Gender & Law
This Article will demonstrate that a pharmacist's refusal to fill a valid prescription for emergency contraception constitutes sex discrimination and violates the WLAD. Part I explains the nature and function of emergency contraceptive pills (ECPs) as well as their role in basic health care for women and the importance of their accessibility. Part II addresses federal civil rights protections and the failure of these protections to provide relief for women facing refusals. Focusing on the WLAD, Part II also explains how state public accommodation statutes protect women from discrimination in places of public accommodation. It further sets forth the prima …
Health 2.0 Online Marketing: Attentio Blogs, Linda Margaret Broughton
Health 2.0 Online Marketing: Attentio Blogs, Linda Margaret Broughton
Linda Margaret Broughton
Health 2.0 and online marketing for health and pharmaceuticals in the EU and the USA
Pharmaceutical Lemons: Innovation And Regulation In The Drug Industry, Ariel Katz
Pharmaceutical Lemons: Innovation And Regulation In The Drug Industry, Ariel Katz
Ariel Katz
Before a new drug can be marketed the Food and Drug Administration must be satisfied that it is safe and effective. According to conventional wisdom, the cost and delay involved in this process diminish the incentives to invest in the development of new drugs. Accordingly, several reforms aimed at restoring such incentives have been implemented and others have been advocated. This paper challenges the central argument in the debate on the topic, namely that drug regulation and drug innovation are necessarily at odds with each other. Although intuitively appealing, the argument that drug regulation negatively affects the incentives to innovate …
The First Amendment And Diet Industry Advertising: How Puffery In Weight-Loss Advertisements Has Gone Too Far, Jennifer E. Gross
The First Amendment And Diet Industry Advertising: How Puffery In Weight-Loss Advertisements Has Gone Too Far, Jennifer E. Gross
Journal of Law and Health
Stricter government regulations regarding commercial speech that promotes weight-loss or diet products should be considered for three reasons. First, studies have shown that diet industry advertising often makes weight loss claims that are scientifically impossible. Second, consumers have suffered adverse health effects as a result of trying weight-loss programs or diet products. Third, current FTC regulations are not curbing the problem. Part II of this note outlines the history of commercial speech and its protections under the First Amendment, along with the history of the rapidly expanding diet industry and its regulatory framework. Part II examines the three arguments in …
The Emerging Bric Economies: Lessons From Intellectual Property Negotiation And Enforcement, Robert C. Bird, Daniel R. Cahoy
The Emerging Bric Economies: Lessons From Intellectual Property Negotiation And Enforcement, Robert C. Bird, Daniel R. Cahoy
Northwestern Journal of Technology and Intellectual Property
No abstract provided.
The Role Of The Fda In Innovation Policy, Rebecca S. Eisenberg
The Role Of The Fda In Innovation Policy, Rebecca S. Eisenberg
Michigan Telecommunications & Technology Law Review
This Article reexamines the role of FDA regulation in motivating investment in biopharmaceutical innovation. I begin by challenging the standard story that it is the patent system that makes drug development profitable, and drug regulation that makes it costly, by showing how patents add to costs and how drug regulation works in tandem with patents to protect profits. I then compare FDA-administered exclusive rights to patents as a means of fortifying drug development incentives, suggesting ways that FDA-administered rights might be preferable both from the perspective of policy makers and from the perspective of firms. In the remainder of the …
Brief Of Amicus Curiae, The National Legislative Association On Prescription Drug Prices, The New Hampshire Medical Society, And Prescription Policy Choices In Support Of Defendant's Objection To Plaintiff's Motion For Preliminary Injunction, Sean Flynn
Amicus Briefs
Plaintiffs in this case seek a preliminary injunction to prevent the enforcement of the New Hampshire Prescription Confidentiality Act, which protects consumers and the privacy interests of doctors in the state of New Hampshire from the increasingly common practice of using doctor-identifying information in prescription records to facilitate targeting of pharmaceutical marketing and gifts toward doctors who prescribe the most expensive drugs for their patients. This practice raises drug costs for all New Hampshire residents and compromises the professional autonomy of doctors. This brief addresses the failure of the plaintiffs to show that they are likely to succeed on the …
El Registro De Nuevos Productos Químicos Conlleva Problemas De Protección De Información, Jose R. Trigueros
El Registro De Nuevos Productos Químicos Conlleva Problemas De Protección De Información, Jose R. Trigueros
Jose R. Trigueros
No abstract provided.
Why Pharmaceutical Firms Support Patent Trolls: The Disparate Impact Of Ebay V. Mercexchange On Innovation, Jeremiah S. Helm
Why Pharmaceutical Firms Support Patent Trolls: The Disparate Impact Of Ebay V. Mercexchange On Innovation, Jeremiah S. Helm
Michigan Telecommunications & Technology Law Review
Before the unanimous decision in eBay v. MercExchange, patent holders were almost always granted an injunction against an infringer. In fact, the Federal Circuit, in deciding eBay, noted that, upon a finding of infringement, an injunction would issue unless there were extraordinary circumstances. The Court, in a brief opinion, disagreed with the Federal Circuit and explained that the injunction issue in a patent case must be analyzed under the traditional four-factor test.[...] Is the four-factor test fairer or better than the Federal Circuit's near-automatic injunction rule? It is certainly more difficult to administer a factor test as compared to a …
Registering New Chemical Products Brings Data Protection Problems, Jose R. Trigueros
Registering New Chemical Products Brings Data Protection Problems, Jose R. Trigueros
Jose R. Trigueros
No abstract provided.
A Tough Pill To Swallow: Does The First Amendment Prohibit Wv From Regulating Pharmaceutical Companies' Advertising Expenses To Lower The Cost Of Prescription Drugs?, Brienne Taylor Greiner
A Tough Pill To Swallow: Does The First Amendment Prohibit Wv From Regulating Pharmaceutical Companies' Advertising Expenses To Lower The Cost Of Prescription Drugs?, Brienne Taylor Greiner
West Virginia Law Review
No abstract provided.
Sometimes The Silence Can Be Like The Thunder: Access To Pharmaceutical Data At The Fda, Peter Lurie, Allison Zieve
Sometimes The Silence Can Be Like The Thunder: Access To Pharmaceutical Data At The Fda, Peter Lurie, Allison Zieve
Law and Contemporary Problems
Those committed to the free exchange of scientific information have long complained about various restrictions on access to the FDA's pharmaceutical data and the resultant restrictions on open discourse. A review of open-government procedures and litigation at the FDA demonstrates that the need for transparency at the agency extend well beyond the reach of any clinical trial registry.
Transparency And Innuendo: An Alternative To Reactive Over-Disclosure, Scott M. Lassman
Transparency And Innuendo: An Alternative To Reactive Over-Disclosure, Scott M. Lassman
Law and Contemporary Problems
Lassman examines the tension between transparency and other public health interests in the context of the FDA's proposed Drug Watch web site. He argues that although the FDA proposal seeks to achieve a laudable goal--the prompt communication of important useful safety information about drug products to physicians and patients-- it fails to properly balance transparency and other legitimate public health interests.
Drugged, Carl E. Schneider
Drugged, Carl E. Schneider
Articles
The Supreme Court's recent decision in Gonzales v. Oregon, like its decision last year in Gonzales v. Raich (the "medical marijuana" case), again raises questions about the bioethical consequences of the Controlled Substances Act. When, in 1970, Congress passed that act, it placed problematic drugs in one of five "schedules," and it authorized the U.S. attorney general to add or subtract drugs from the schedules. Drugs in schedule II have both a medical use and a high potential for abuse. Doctors may prescribe such drugs if they "obtain from the Attorney General a registration issued in accordance with the …
The Trademark Dilution Revision Act - A Consumer Perspective, Paul Alan Levy
The Trademark Dilution Revision Act - A Consumer Perspective, Paul Alan Levy
Fordham Intellectual Property, Media and Entertainment Law Journal
No abstract provided.
The Hatch-Waxman Act And Market Exclusivity For Generic Manufacturers: An Entitlement Or An Incentive?, Ashlee B. Mehl
The Hatch-Waxman Act And Market Exclusivity For Generic Manufacturers: An Entitlement Or An Incentive?, Ashlee B. Mehl
Chicago-Kent Law Review
One of Congress' central goals in enacting the Hatch-Waxman Act was to expedite and encourage earlier market entry for generic pharmaceutical products. The Act provides that a generic firm may challenge a drug patent during its term by filing paperwork with the FDA that alleges either that its generic product does not infringe the relevant patent, or that the patent is invalid. If the patentee disagrees with the allegation of the generic firm, it may file suit and have a court determine infringement and validity. If the generic firm prevails in court on either count, it may enter the market …
Paper Dragon: Inadequate Protection Of Intellectual Property Rights In China, Omario Kanji
Paper Dragon: Inadequate Protection Of Intellectual Property Rights In China, Omario Kanji
Michigan Journal of International Law
This Note will explore the extent to which China is in violation of its obligations under TRIPs. Section I surveys the current state of IPR infringement in China. Section II analyzes relevant TRIPs provisions, case law, and treaties that supplement TRIPs provisions. Section III analyzes Chinese criminal law, the December 2004 Judicial Interpretation of Chinese criminal law, and Chinese IP law as they pertain to IPR infringement. Section IV outlines enforcement efforts in China against the backdrop of the law analyzed in the previous section. Section V evaluates these enforcement efforts given China's capabilities and obligations, and Section VI concludes …
Settlements Between Brand And Generic Pharmaceutical Companies: A Reasonable Antitrust Analysis Of Reverse Payments, Anne-Marie C. Yvon, Ph.D.
Settlements Between Brand And Generic Pharmaceutical Companies: A Reasonable Antitrust Analysis Of Reverse Payments, Anne-Marie C. Yvon, Ph.D.
Fordham Law Review
No abstract provided.
Consolidating Pharmaceutical Regulation Down Under: Policy Options And Practical Realities, Frances H. Miller
Consolidating Pharmaceutical Regulation Down Under: Policy Options And Practical Realities, Frances H. Miller
Faculty Scholarship
Pharmaceutical regulatory agencies struggle worldwide to maintain public trust these days. Drug safety issues proliferate,' the costs of lharmaceuticals take increasingly larger shares of most countries' health service spending, and conflicts of interest afflicting the drug approval and marketing processes capture more and more public attention. The Australian and New Zealand governments are keenly aware of these problems, and have been attempting to forge a regulatory alliance to combine their respective pharmaceutical regulatory agencies, Australia's Therapeutic Goods Administration (TGA) and New Zealand's Medicines and Medical Devices Safety Authority (Medsafe), into the pending Trans Tasman Therapeutic Products Authority (ANZTPA, or TPA). …
The (Legal) Pains Of Vioxx: Why Product Liability Can Make Products More Dangerous, Omri Ben-Shahar
The (Legal) Pains Of Vioxx: Why Product Liability Can Make Products More Dangerous, Omri Ben-Shahar
Articles
Comparing the experience of Vioxx and Celebrex leads Omri Ben-Shahar to think that stiff product liability has the perverse effect of inducing manufacturers of defective products to leave these products on the market, rather than withdraw them.
Supporting Innovation In Targeted Treatments: Licenses Of Right To Nih-Funded Research Tools, Tanuja V. Garde
Supporting Innovation In Targeted Treatments: Licenses Of Right To Nih-Funded Research Tools, Tanuja V. Garde
Michigan Telecommunications & Technology Law Review
Support for new drug development has taken some interesting turns in current patent law jurisprudence. Beginning with the severe curtailment of scope of the common law experimental use doctrine in Madey v. Duke University, and culminating with the recent Supreme Court decision in Merck KGaA v. Integra Lifesciences I, Ltd., broadening the scope of the statutory research exemption, the freedom to conduct experimental research using another's patented inventions becomes dependent in part on the purpose of the research. That the patent at issue in Merck was characterized by the Federal Circuit as being directed to a research tool raised the …
The Problem Of New Uses, Rebecca S. Eisenberg
The Problem Of New Uses, Rebecca S. Eisenberg
Articles
Discovering new uses for drugs that are already on the market seems like it ought to be the low-lying fruit of biopharmaceutical research and development (R&D). Firms have already made significant investments in developing these drugs and bringing them to market, including testing them in clinical trials, shepherding them through the FDA regulatory approval process, building production facilities, and training sales staff to market them to physicians. By this point, the drugs have begun to enjoy goodwill among patients and physicians and casual observations in the course of clinical experience may point to potential new uses. One might expect that …
Staying Within The Negotiated Framework: Abiding By The Non-Discrimination Clause In Trips Article 27, Kevin J. Nowak
Staying Within The Negotiated Framework: Abiding By The Non-Discrimination Clause In Trips Article 27, Kevin J. Nowak
Michigan Journal of International Law
This Note argues that the Panel in Canada-Generic Medicines correctly decided that the non-discrimination clause in Article 27 applies to the exceptions of Articles 30 and 31. Because Article 27 is the guiding force of Section 5, any exceptions to the rights granted under Section 5 must comply with the requirements set forth in Article 27. Although extreme applications of the non-discrimination clause could be limiting upon some exceptions, Articles 30 and 31 were not placed into TRIPs as complete escape clauses from the framework of Section 5. Additionally, the application of the non-discrimination clause to Articles 30 and 31 …
Learning The Value Of Drugs - Is Rofecoxib A Regulatory Success Story?, Rebecca S. Eisenberg
Learning The Value Of Drugs - Is Rofecoxib A Regulatory Success Story?, Rebecca S. Eisenberg
Articles
Controversy over recent revelations concerning the adverse cardiovascular effects of selective cyclooxygenase- 2 (COX-2) inhibitors has generally been framed as a story of regulatory failure, in which the Food and Drug Administration (FDA) has failed in its mission to protect the public from unsafe products. But this simplistic understanding of the mission of the FDA seems to make failure all but inevitable, if the reliable observation of the risks and benefits of a drug requires rigorous long-term studies. Perhaps in an earlier era the goal of drug regulation was simply to protect the public from poisons. Today, drug regulation guides …
The Experimental Purpose Doctrine And Biomedical Research, Tao Huang
The Experimental Purpose Doctrine And Biomedical Research, Tao Huang
Michigan Telecommunications & Technology Law Review
The experimental use doctrine is a common law rule in patent law that until a few years ago excused accused infringers who made and used patented products or processes on the basis of an experimental, educational, or nonprofit purpose when there was de minimis economic injury to the patent owner and de minimis economic gain to the infringer. While the application of the experimental purpose doctrine was always narrow, two recent Federal Circuit decisions indicate that there is not much left under its aegis. In Madey v. Duke University, the Federal Circuit strictly limited the application of the experimental purpose …
An Examination Of Patents, Licensing, Research Tools, And The Tragedy Of The Anticommons In Biotechnology Innovation, Michael S. Mireles
An Examination Of Patents, Licensing, Research Tools, And The Tragedy Of The Anticommons In Biotechnology Innovation, Michael S. Mireles
University of Michigan Journal of Law Reform
The continued development of and affordable access to potentially life saving pharmaceuticals, gene therapies and diagnostics is unquestionably a socially important issue. However, crafting government policy to encourage the development of and allowing affordable access to those services and products is difficult. On one hand, the development of those services and products requires a large investment of funds because of the complexity, collaborative nature, and uncertainty of the development of those products and services. Accordingly, investors require the safety of strong and stable patent rights to ensure a return on their investment in the development of a commercial end-product or …
Sell V. United States: Involuntary Administration Of Antipsychotic Medication To Criminal Defendants, Brandy M. Rapp
Sell V. United States: Involuntary Administration Of Antipsychotic Medication To Criminal Defendants, Brandy M. Rapp
University of Richmond Law Review
No abstract provided.
Economic Analyses Of Patent Settlement Agreements: The Implementation Of Specific Economic Tests, The Evaluation Of Dynamic Efficiency, And The Scope Of Patent Rights, James Langenfeld, Wenqing Li
Economic Analyses Of Patent Settlement Agreements: The Implementation Of Specific Economic Tests, The Evaluation Of Dynamic Efficiency, And The Scope Of Patent Rights, James Langenfeld, Wenqing Li
University of San Francisco Law Review
No abstract provided.
Border Patrol, Carl E. Schneider
Border Patrol, Carl E. Schneider
Articles
Recently, the Supreme Court has encountered cases that concern perhaps our weightiest bioethical issue-how medical care is to be rationed. But this does not mean that the Court must therefore assess the justice of rationing, as many people incited by many journalists now fondly and firmly believe. In explaining why, we begin with a story about how Learned Hand remembered saying one day to Justice Holmes, "Well, sir, goodbye. Do justice!" Holmes turned quite sharply and said: "That is not my job. My job is to play the game according to the rules." If the Court doesn't do justice, what …
Drug Regulations And The Constitution After Western States, Margaret Gilhooley
Drug Regulations And The Constitution After Western States, Margaret Gilhooley
University of Richmond Law Review
No abstract provided.