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Full-Text Articles in Law
Improving Generic Drug Approval At The Fda, Kathleen Craddock
Improving Generic Drug Approval At The Fda, Kathleen Craddock
Michigan Journal of Environmental & Administrative Law
Generic drugs are the store-brand cereal of the drug world. While they lack the vibrant colors of and exciting commercials behind name brands, generics are still effective. Most importantly, for some people, they make the difference between accessing essential treatment and going without. Getting generics to market as quickly as possible means fewer people will cut pills in half or skip doses to save money, which also saves billions of dollars across the U.S. health system. Because a new generic does not offer lifesaving changes for people with rare or complicated diseases, generics lack the “cultural capture of rhetoric about …
Reconsidering Regulatory Uncertainty: Making A Case For Energy Storage, Amy L. Stein
Reconsidering Regulatory Uncertainty: Making A Case For Energy Storage, Amy L. Stein
Florida State University Law Review
This Article begins the complex dialogue that must take place to address the emerging technologies providing energy storage for our electricity grid. Energy storage has the capacity to be a game-changer for many facets of our grid, providing better integration of renewable energy, enhanced reliability, and reduced use of carbon-intensive fuels. Energy storage faces a number of obstacles, however, including technological, financial, and regulatory uncertainty. This Article focuses on the regulatory uncertainty, and defends the proposition that not all regulatory uncertainty is created equal. It argues for differential treatment of this uncertainty, depending on its context, scope, and source, and …
Protecting The Innocent With A Premium For Child Safety Regulations, Jacob P. Byl
Protecting The Innocent With A Premium For Child Safety Regulations, Jacob P. Byl
University of Massachusetts Law Review
Federal agencies regulate many products and activities that impact the safety of children. Agencies should put a premium on saving the lives of children when analyzing the costs and benefits of proposed regulations. This note uses original evidence from the infant car seat market to determine that a child-specific benefit measure should be one and a half to two times that of an adult. A child premium will encourage more regulations that protect the safety of our society's most precious and innocent members.
Dilution At The Patent And Trademark Office, Jeremy N. Sheff
Dilution At The Patent And Trademark Office, Jeremy N. Sheff
Michigan Telecommunications & Technology Law Review
This Article undertakes the first systematic investigation of trademark dilution in registration practice before the US Patent and Trademark Office (PTO). The Article consists of three distinct descriptive empirical analyses. In the first, I present a new hand-coded dataset of all 453 Trademark Trial and Appeal Board (TTAB) dispositions of dilution claims through June 30, 2014, and report that dilution has been necessary to the PTO’s refusal of exactly three registrations in over a decade. In the second part, I apply algorithmic coding of the recently released PTO Casefiles Dataset to demonstrate that concurrent registration of identical marks to different …
Should The State Pay The Fees Of Claimant Representatives In Unemployment Insurance Hearings?, Paul Wyler
Should The State Pay The Fees Of Claimant Representatives In Unemployment Insurance Hearings?, Paul Wyler
Journal of the National Association of Administrative Law Judiciary
No abstract provided.
Burying, Robert Brendan Taylor
Burying, Robert Brendan Taylor
Michigan Telecommunications & Technology Law Review
When applying for a patent, applicants must provide the examiner with all known material prior art. Those who fail to do so can be charged with inequitable conduct. But applicants can still effectively hide material prior art references by submitting them along with large quantities of immaterial prior art to the examiner. This deceptive practice, known as "burying," is generally not considered inequitable conduct. This Essay summarizes the current legal landscape concerning burying, discusses the costs associated with the practice, and suggests ways to deter and punish those who do it.
The $1.75 Trillion Lie, Lisa Heinzerling, Frank Ackerman
The $1.75 Trillion Lie, Lisa Heinzerling, Frank Ackerman
Michigan Journal of Environmental & Administrative Law
A 2010 study commissioned by the Office of Advocacy of the U.S. Small Business Administration claims that federal regulations impose annual economic costs of $1.75 trillion. This estimate has been widely circulated, in everything from op-ed pages to Congressional testimony. But the estimate is not credible. For costs of economic regulations, the estimate reflects a calculation that rests on a misunderstanding of the definition of the relevant data, flunks an elementary question on the normal distribution, pads the analysis with several years of near-identical data, and fails to recognize the difference between correlation and causation. For costs of environmental regulation, …
Rational Electricity Regulation: Environmental Impacts And The "Public Interest", Jeremy Knee
Rational Electricity Regulation: Environmental Impacts And The "Public Interest", Jeremy Knee
West Virginia Law Review
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.
Beyond The Limits Of Executive Power: Presidential Control Of Agency Rulemaking Under Executive Order 12,291, Morton Rosenberg
Beyond The Limits Of Executive Power: Presidential Control Of Agency Rulemaking Under Executive Order 12,291, Morton Rosenberg
Michigan Law Review
This Article addresses the substantial legal problems posed by Executive Order 12,291. Part I argues that the Order, taken as a whole or separated into its procedural and substantive components, violates the constitutional separation of powers. Drawing on the analytic framework outlined by Justice Jackson in the Steel Seizure case, Part I maintains that courts should demand clear congressional support for the Order's requirements. The available evidence, however, conclusively demonstrates Congress's intent to deny the President formalized, substantive control over administrative policymaking. As interpreted by the Supreme Court, moreover, the informal rulemaking provisions of the Administrative Procedure Act (AP A) …
Gilmore: An Antidumping Proceeding As Cost-Price Comparison, Fred A. Rodriguez
Gilmore: An Antidumping Proceeding As Cost-Price Comparison, Fred A. Rodriguez
Michigan Journal of International Law
In the usual dumping case, a producer sells his product abroad at prices lower than those at which the same product is sold in the domestic market (country of origin). But dumping is also possible in other circumstances. The General Agreement on Tariffs and Trade (hereinafter GATT) and the Antidumping Code (hereinafter the Code) recognize dumping where, in the absence of a domestic price, the price in the export market is lower than the price for a comparable product in a third country market. If neither a domestic nor a third country price is available, these international agreements provide that …
Financial Barriers To Public Participation In The Regulatory Process, Henry E. Howell Jr.
Financial Barriers To Public Participation In The Regulatory Process, Henry E. Howell Jr.
William & Mary Law Review
No abstract provided.