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Articles 1 - 7 of 7
Full-Text Articles in Law
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 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 …
Tax Law Uncertainty And The Role Of Tax Insurance, Kyle D. Logue
Tax Law Uncertainty And The Role Of Tax Insurance, Kyle D. Logue
Articles
In the broadest sense, this is an article about legal or regulatory uncertainty and the role that private and public insurance can play in managing it. More narrowly, the article is about tax law enforcement and the familiar if ill-defined distinctions between tax evasion, tax avoidance, and abusive tax avoidance. Most specifically, the article is about a new type of tax risk insurance policy, sometimes called tax indemnity insurance or transactional tax risk insurance that provides coverage against the risk that the Internal Revenue Service (Service) will disallow a taxpayer-insured's tax treatment of a particular transaction. The question is whether …
The Sec At 70: Time For Retirement?, Adam C. Pritchard
The Sec At 70: Time For Retirement?, Adam C. Pritchard
Articles
The Article proceeds as follows. Part I explains the pathologies of the SEC and explores the relation between those pathologies and the SEC's status as an independent agency. Part II then outlines an alternative regulatory structure primarily situated within the executive branch. I also argue that such a relocation of authority would enhance regulatory effectiveness while simultaneously reducing the cost of excessive regulation. The Article concludes with some thoughts about the viability of my proposal.
The Sec At 70: Time For Retirement?, Adam C. Pritchard
The Sec At 70: Time For Retirement?, Adam C. Pritchard
Articles
As one grows older, birthdays gradually shift from being celebratory events to more reflective occasions. One's 40th birthday is commemorated rather differently from one's 2lst, which is, in turn, celebrated quite differently from one's first. After a certain point, the individual birthdays become less important and it is the milestone years to whch we pay particular attention. Sadly for entities like the Securities and Exchange Commission, it is only the milestone years (the ones ending in five or zero, for some reason), that draw any attention at all. No one held a conference to celebrate the SEC's 67th anniversary. Clearly …
Prometheus Radio Project V. Fcc: The Persistence Of Scarcity, Aaron Perzanowski
Prometheus Radio Project V. Fcc: The Persistence Of Scarcity, Aaron Perzanowski
Articles
Part I traces the history of broadcast regulation, emphasizing the development of the scarcity doctrine and the subsequent deregulatory trend. Part II examines the FCC's 2003 rule changes and the Third Circuit's analysis of those modifications in Prometheus Radio Project v. FCC. Part III analyzes the assumptions underlying the FCC's proffered explanation for its rule changes, ultimately concluding that they lack justification, and offers suggestions for responsible ownership deregulation. Part IV calls on Congress to reassert itself as the final arbiter of media policy.
After 70 Years Of The Nlrb: Warm Congratulations -- And A Few Reservations, Theodore J. St. Antoine
After 70 Years Of The Nlrb: Warm Congratulations -- And A Few Reservations, Theodore J. St. Antoine
Articles
The following essay is based on a talk the speaker was invited to deliver to the National Labor Relations Board on June 3 in Washington, D.C., on the occasion of the agency's 70th anniversary.