Notice & Comment

Author: Sam Halabi

Notice & Comment

Where It Hurts

It’s unclear how many Americans fully understand the meaning of the U.S. (and many other countries’) “one China policy” and the history behind it, but Donald Trump’s recent phone call with Tsai Ing-wen, the Taiwanese president who won this year’s elections in part on an interpretation of “one China” that included greater autonomy for Taiwan, […]

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Obama, Trump, and Infectious Diseases as National Security Threats

One of the distinguishing features of the Obama administration’s approach to national security threats has been the priority given to infectious diseases. Clinton and George W. Bush established their own programs devoted in substantial measure to HIV/AIDS but the Obama administration, from 2009, dedicated far more of its security planning resources to outbreaks of infectious […]

Notice & Comment

Administrative Law as Prerequisite

Stepping away from research interests for a post, I thought I’d pose a teaching-related question to the bloggers and readers of Notice and Comment: for which courses that you (or others you know) teach is Administrative Law a mandatory prerequisite? After two weekends spent at conferences where I had a chance to catch up with […]

Notice & Comment

How Private Food Safety Standards Restrict Access to Markets (and the Desirability of Doing So)

In general, private food safety standards might be regarded as beneficial for both producers and consumers. If Walmart, for example, imposes a requirement on its supplier farms to use chemical fertilizers instead of manure, an important safety risk is minimized (although with other perhaps less desirable costs imposed on farmers and their environment), consumers’ food […]

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What Exactly is Global GAP and Where Did it Come From?

To understand how private food safety standards have emerged as competitors with regulations adopted through more conventional public law processes, it is worth understanding how the major private standard setter – Global GAP – works and where it came from. The movement for private certification of farming practices resulted from two related consumer pressures and […]

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The Battle between Public and Private Food Safety Standards

One of the many far-reaching provisions of the 2011 Food Safety Modernization Act (FSMA) authorizes a voluntary program for the accreditation of third-party certification bodies, also known as auditors, to conduct food safety audits and issue certifications of foreign facilities and the foods for humans and animals they produce. FDA finalized this rule in 2015 […]

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If There’s No Such Thing as Medical Marijuana, How Do We Have Medical Marijuana?

This week, the Drug Enforcement Agency (DEA) responded to petitions requesting a redesignation of marijuana for the benefit of scientific research. The DEA refused, citing, somewhat tautologically, the fact that there are no scientifically valid and well-controlled clinical trials demonstrating benefits for certain modalities of marijuana for specific medical indications.  DEA affirmed marijuana’s continued status […]

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The Predictable but Disappointing Outcome of Universal Health Services v. United States ex. rel. Escobar

On June 16, 2016, Justice Clarence Thomas wrote for a unanimous Supreme Court that so-called “implied certification” theories supporting False Claims Act suits were permissible under the statute but ultimately sided with the government contractor because “if the Government pays a particular claim in full despite its actual knowledge that certain requirements were violated, that […]

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Zika and Pregnancy-Specific Vaccines’ Regulatory Lacunae

In my next two posts, I will investigate the relationship between regulatory approval of vaccines and the response to the global public health emergency surrounding the spread of the Zika virus. That emergency has resurrected and brought into sharper relief some of the most vexing questions surrounding the regulatory state and pregnancy: the appropriate circumstances, […]

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FDA’s Memoranda of Understanding, Quasi-Treaties, and their Role in the Future of Global Administrative Law

In my last post, I detailed the kinds of agreements FDA uses with regulatory partners as part of a three-post series that examines FDA through the lens on the growing literature on “global administrative law.” This final post analyzes FDA’s “steepest” commitments with regulatory partners and argues that in the process of contributing to global […]

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FDA’s International Agreements: Typologies and Purposes

In my last post, I situated FDA’s international agreements in the literature on “global administrative law” and suggested that the field’s leaders take too narrow a view of what regulators do in the process of “making” global administrative law. Their regulatory mission is often much broader than the product or sector so-described. FDA’s international agreements […]

Notice & Comment

FDA and Global Administrative Law

In 2005, Benedict Kingsbury, Nico Krisch, and Richard Steward published their foundational article,The Emergence of Global Administrative Law, in which they argued that a discrete if amorphous body of law existed comprised of transgovernmental regulation and administration “designed to address the consequences of globalized interdependence in such fields as . . . environmental protection . […]