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Full-Text Articles in Law
The Pharma Barons: Corporate Law's Dangerous New Race To The Bottom In The Pharmaceutical Industry, Eugene Mccarthy
The Pharma Barons: Corporate Law's Dangerous New Race To The Bottom In The Pharmaceutical Industry, Eugene Mccarthy
Michigan Business & Entrepreneurial Law Review
In this Article, I argue that drug companies have created a highly profitable but dangerous business model by employing the same legal tactics as the nineteenth-century “robber barons,” the group of financiers who orchestrated corporate law’s infamous race to the bottom. Like these historical financiers, drug company executives have captured the legal apparatus and regulatory bodies that oversee them. In so doing, they have transformed the law from a system of governance into a set of enabling doctrines. The pharmaceutical industry has turned legislation intended to protect the public into a legal justification for marketing ineffective and unsafe prescription drugs. …
Update On Antitrust And Pay-For-Delay: Evaluating “No Authorized Generic” And “Exclusive License” Provisions In Hatch-Waxman Settlements, Saami Zain
San Diego Law Review
In Federal Trade Commission v. Actavis, the United States Supreme Court held that a patent litigation settlement where a branded drug company pays a generic drug company to end the litigation and delay launching its generic may violate the antitrust laws. Although the decision ended years of controversy over whether such settlements were subject to antitrust scrutiny, many issues remain unresolved concerning the lawfulness of these settlements. In particular, courts have struggled in assessing the legality of patent settlements between branded and generic drug manufacturers involving non-cash compensation or benefits. This article discusses one type of non-cash compensation that is …
The Cost Of Confusion: The Paradox Of Trademarked Pharmaceuticals, Hannah Brennan
The Cost Of Confusion: The Paradox Of Trademarked Pharmaceuticals, Hannah Brennan
Michigan Telecommunications & Technology Law Review
The United States spends nearly $1,000 per person annually on drugs—forty percent more than the next highest spender, Canada, and more than twice the amount France and Germany spend. Although myriad factors contribute to high drug spending in the United States, intellectual property law plays a crucial and well-documented role in inhibiting access to cheaper, generic medications. Yet, for the most part, the discussion of the relationship between intellectual property law and drug spending has centered on patent protection. Recently, however, a few researchers have turned their attention to a different avenue of exclusivity—trademark law. New studies suggest that pharmaceutical …
New Dtca Guidance — Enough To Empower Consumers?, Christopher Robertson
New Dtca Guidance — Enough To Empower Consumers?, Christopher Robertson
Faculty Scholarship
As one of only two countries that permit direct-to-consumer advertising (DTCA) of pharmaceuticals, the United States tasks the Food and Drug Administration (FDA) with regulating that advertising to ensure that it doesn't mislead consumers. When a drug maker publishes or broadcasts a claim that its drug has benefits in a particular disease, the FDA requires it to include information on the product's risks as well. Since it's not feasible for companies to include all the important information about their products in a television ad, the FDA requires them to refer viewers to more complete information, such as that in a …
Sacrificial Lambs: Compensating First Subscribers To Fda-Approved Medications For Postmarketing Injuries Resulting From Unlabeled Adverse Events, Rodney K. Miller
Sacrificial Lambs: Compensating First Subscribers To Fda-Approved Medications For Postmarketing Injuries Resulting From Unlabeled Adverse Events, Rodney K. Miller
Catholic University Law Review
No abstract provided.
The Fda, Preemption, And Public Safety: Antiregulatory Effects And Maddening Inconsistency, Lawrence O. Gostin
The Fda, Preemption, And Public Safety: Antiregulatory Effects And Maddening Inconsistency, Lawrence O. Gostin
Georgetown Law Faculty Publications and Other Works
Most people think of preemption as a technical constitutional doctrine, but it is pivotally important to health and safety, while also opening the door to broad judicial discretion. The Rehnquist and Roberts Courts’ pro-business/pro-preemption jurisprudence is distinctly antiregulatory, invalidating major state public health rules, such as in occupational safety, tobacco control, and motor vehicle safety. Apart from the antiregulatory effects, there is maddening inconsistency. Consider three relatively recent Supreme Court cases. In Riegel v. Medtronic, Inc. (2008), the Court held that federal law bars injured consumers from challenging the safety or effectiveness of FDA-approved medical devices. A year later, …
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.
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.
Legislative Notes: The Fda's Over-The Counter Drug Review: Expeditious Enforcement By Rulemaking, David Selmer
Legislative Notes: The Fda's Over-The Counter Drug Review: Expeditious Enforcement By Rulemaking, David Selmer
University of Michigan Journal of Law Reform
This article attempts to show that the OTC drug review has distinct advantages over traditional drug regulation. Part I outlines briefly the traditional case-by-case approach to drug licensing and describes FDA enforcement efforts prior to the OTC drug review. Part II sets forth the new rulemaking approach and considers the use of advisory panels. Part III examines several procedural questions associated with the review and concludes that the use of monographs as regulatory standards will afford the FDA an expeditious enforcement mechanism by resolving complex scientific issues at the administrative rather than the judicial level. Judicial review should be available, …
The Prosubstitution Trend In Modern Pharmacy Law, Sidney H. Willig
The Prosubstitution Trend In Modern Pharmacy Law, Sidney H. Willig
University of Michigan Journal of Law Reform
This article explores the legal problems presented to the practicing pharmacist by drug substitution. It delineates the practical and economic realities bearing on substitution and the arguments both in favor of and against limited legal substitution. After describing the current status of the law on the subject and the various resultant liabilities of the pharmacist, the article then suggests means by which substitution might be made an acceptable practice in certain circumstances.