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A Journal of the Yale Law School

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Latest Post on Notice & Comment

Strategies for International Drug and Vaccine Regulatory Coordination and Cooperation – the Role of Aid and Public Health Personnel, by Sam Halabi
JREG Notice and Comment - Wednesday, May 20, 2015

In my last post, I observed that there was a dilemma posed by the current system of producing and moving medicines and vaccines from the developed, wealthy countries of North America, Europe and the Pacific Rim to low-resource countries in Asia, Africa and South America. The public health urgency of distributing medicines and vaccines often pressures funders and providers to side step national regulatory authorities because their lack of capacity may at best delay access to essential medicines and vaccines and at worst feed corruption or waste. On the other hand, the development of strong regulatory capacity in low-resource countries is one of the critical needs not only for those countries themselves but for the global supply chain of medicines and vaccines which is most vulnerable to breaches of safety and potency in underregulated or unregulated markets. One solution to this problem is for the aid and public health authorities from wealthier countries to better coordinate their roles and responsibilities with respect to public health response and regulatory capacity building.   Read more...

More on FERC and Demand Response, by Bruce Huber
JREG Notice and Comment - Tuesday, May 19, 2015

As Andy Hessick noted a few posts back, the Supreme Court recently granted cert in an important energy law case. FERC v. Electric Power Supply Association deals with FERC’s attempt to create a demand response program at the wholesale level. This is an issue that I’ve blogged about before; other scholars have written some great posts about the case here and here. For the moment, though, I only wanted to note that I’ve recently posted on SSRN a short essay, published recently by the Iowa Law Review Bulletin, written in reply to a nice article by Sharon Jacobs. Jacobs’ take is intriguing. She argues that in structuring its demand response program, FERC “bypassed” federalism by avoiding a direct confrontation with the states or Congress and instead using an area of relatively clear jurisdictional authority to work a de facto shift in the state/federal balance. Of course, the Supreme Court will tell us this fall or winter just how sound was FERC’s reasoning. Meanwhile, sit back, relax, and enjoy your moderately priced electricity.   Read more...

More Unlawful ACA Premium Tax Credits, by Andy Grewal
JREG Notice and Comment - Tuesday, May 19, 2015

I might be accused of picking at low-hanging fruit, but I’d nonetheless like to devote another blog post to more IRS regulations that expand and contradict Section 36B. My prior blog posts, which I’ve adapted into an essay upcoming in Bloomberg BNA, discuss regulations that improperly extend ACA premium tax credits to persons in the Medicare coverage gap and to some unlawful aliens. In this post, I want to highlight regulations that improperly penalize employers and that give credits to taxpayers already enrolled in employer-sponsored minimum essential coverage.   Read more...

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