Law Commons^™

Manufacturing Barriers To Biologics Competition And Innovation, W. Nicholson Price Ii., Arti K. Rai

Articles

As finding breakthrough small-molecule drugs becomes more difficult, drug companies are increasingly turning to "large molecule" biologics. Although biologics represent many of the most promising new therapies for previously intractable diseases, they are extremely expensive. Moreover, the pathway for generic-type competition set up by Congress in 2010 is unlikely to yield significant cost savings. This Article provides a fresh diagnosis of and prescription for this major public policy problem. It argues that the key cause is pervasive trade secrecy in the complex area of biologics manufacturing. Under the current regime, this trade secrecy, combined with certain features of Food and …

What Should Tribes Expect From Federal Regulations? The Bureau Of Land Management's Fracking Rule And The Problems With Treating Indian And Federal Lands Identically, Monte Mills

Articles

On March 26, 2015, the Bureau of Land management (BLM) published its Final Rule regarding Hydraulic Fracturing on Federal and Indian Lands (Final Rule). Work on the Rule had begun nearly four and a half years earlier as a way to update the agency’s outdated regulatory scheme to account for new fracking technology and growing public concern over the practice and potential safety concerns related to fracking.

The Final Rule amassed a number of procedural and substantive requirements for fracking operations and proposed to apply these standards uniformly to both public lands and lands held in trust by the Federal …

In Praise Of (Some) Ex Post Regulation: A Response To Professor Galle, Kyle D. Logue

Articles

According to modern law-and-economics (“L&E”) orthodoxy, the primary—maybe even the only—legitimate justification for government regulation is to correct a market failure. This conclusion is based on two key assumptions. First, when markets are functioning reasonably well, they are better at achieving efficiency than the government is. Second, most markets function reasonably well most of the time. Although there is probably evidence to support these assumptions (for example, the relative prosperity of market-based economies in comparison with the relative poverty of centrally planned economies), both assumptions are usually taken as articles of faith by mainstream L&E scholars. This is why scholarly …

The Perverse Effects Of Subsidized Weather Insurance, Omri Ben-Shahar, Kyle D. Logue

Articles

This Article explores the role of insurance as a substitute for direct regulation of risks posed by severe weather. In pricing the risk of human activity along the predicted path of storms, insurance can provide incentives for efficient location decisions as well as for cost-justified mitigation efforts in building construction and infrastructure. Currently, however, much insurance for severe-weather risks is provided and heavily subsidized by the government. This Article demonstrates two primary distortions arising from the government’s dominance in these insurance markets. First, existing government subsidies are allocated differentially across households, resulting in a significant regressive redistribution favoring affluent homeowners …

Regulation Of Emerging Risk, Matthew T. Wansley

Articles

Why has the EPA not regulated fracking? Why has the FDA not regulated e-cigarettes? Why has NHTSA not regulated autonomous vehicles? This Article argues that administrative agencies predictably fail to regulate emerging risks when the political environment for regulation is favorable. The cause is a combination of administrative law and interest group politics. Agencies must satisfy high, initial informational thresholds to regulate, so they postpone rulemaking in the face of uncertainty about the effects of new technologies. But while regulators passively acquire more information, fledgling industries consolidate and become politically entrenched. By the time agencies can justify regulation, the newly …