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Undue Process at the FDA
Get PDFFor over 40 years, the Food and Drug Administration has been collecting evidence that the routine administration of antibiotics to animals destined for the food supply contributes to the development of antibiotic-resistant infections in the human population. For all these years, the FDA has put off acting with any force on this health risk. The agency’s explanation has been that the Food, Drug and Cosmetic Act requires it to hold time- and resource-intensive formal hearings before it can withdraw approvals for antibiotics used for the purposes of promoting growth and preventing infection in food animals. In so arguing, the FDA has ignored decades of developments in administrative law and has misread its own statute. The FDA has the discretion under the law to act on antibiotics in animal feed without going through the years-long process of formal hearings. At the least, the agency owes the public an explanation of why it has insisted on pursuing the longest possible path to protecting human health.
The FDA’s legal error is, in principle, simple enough to correct. Far less remediable are the habits of mind that entrench agency inaction, including institutional memory that privileges stasis over change and systematic acceptance of absurdly long timelines for addressing social problems. Equally immobilizing are statutory grants of epistemic authority to particular individuals within large bureaucratic institutions, which allow these institutions officially to deny certain facts about the world even while they report them as the truth
State Law, the Westfall Act, and the Nature of the \u3ci\u3eBivens\u3c/i\u3e Question
Get PDFIn a number of recent cases touching to varying degrees on national security, different courts of appeals have applied a strong presumption against recognition of a Bivens cause of action. In each of these cases, the courts’ approach was based on the belief that the creation of a cause of action is a legislative function and that the courts would be usurping Congress’s role if they recognized a Bivens action without legislative authorization. Thus, faced with a scenario where they believed that the remedial possibilities were either Bivens or nothing, these courts of appeals chose nothing.
The concerns that led these courts to decline to recognize a Bivens action, if truly implicated by these cases, would be reasons to bar the suits from the courts altogether. In contrast, as we explain in this essay, the Bivens question was at least initially understood as whether a federal cause of action should supplement existing state law remedies. Thus, these recent lower-court decisions reveal a fundamental misapprehension about the intended relationship between Bivens and state law. So understood, and as courts have already recognized in other contexts, the very concerns relied upon in these recent national security cases would, if anything, have traditionally supported a federal remedial regime rather than one under state law. As the Supreme Court\u27s recent decision in Minneci v. Pollard illustrates, the principal reason to disfavor recognition of Bivens remedies should be the availability of adequate remedies under state law, and not a desire to immunize the relevant officers from any liability whatsoever. Thus, unlike these recent cases, decisions not to recognize a Bivens remedy should leave the plaintiff free to pursue whatever recourse state law may provide.
Although this view of Bivens was generally shared by both its supporters and detractors when it was decided, it has receded from view largely thanks to the Westfall Act, which most courts and commentators today read as preempting all state-law tort claims against federal officers acting within the scope of their employment. In our view, this conclusion reflects a surprising misreading of the Act, which specifically exempts from its preemption provision any claim which is brought for a violation of the Constitution of the United States, presumably including non-federal tort claims grounded on federal constitutional violations. Indeed, given that the legislative history of the Westfall Act suggests that Congress merely sought to preserve the status quo, it is odd to read the statute as dramatically altering the nature and consequences of the Bivens question.
Nevertheless, if the Westfall Act does indeed have this effect, we conclude that it should therefore significantly strengthen the argument for recognizing Bivens claims, since the Act takes away the main alternative remedial scheme that previously existed. Indeed, an (incorrect) interpretation of the Westfall Act as preempting non-federal remedies but not authorizing equivalent federal remedies may well raise significant constitutional questions--questions that have thus far been dramatically under-appreciated by the lower courts, but that must be taken seriously going forward. And if courts conclude that, in appropriate cases, the question really should be Bivens or nothing, they must recognize that either answer requires judicial lawmaking--and not just recognition of a federal cause of action
Stemming the Global Trade in Falsified and Substandard Medicines
Get PDFDrug safety and quality is an essential assumption of clinical medicine, but there is growing concern that this assumption is not always correct. Poor manufacturing and deliberate fraud occasionally compromises the drug supply in the United States, and the problem is far more common and serious in low- and middle-income countries with weak drug regulatory systems. An Institute of Medicine consensus committee report identified the causes and possible solutions to the problem of falsified and substandard drugs around the world.
The vocabulary people use to discuss the problem is itself a concern. The word counterfeit is often used innocuously to describe any drug that is not what it seems, but some NGOs and emerging manufacturing nations object to this term. These groups see hostility to generic pharmaceuticals in a discussion of counterfeit medicines. These groups see hostility to generic pharmaceuticals in a discussion of counterfeit medicines. Precisely speaking, a counterfeit drug infringes on a registered trademark, and trademark infringement in not necessarily a problem of public health consequence. Instead of talking broadly about counterfeit drugs, the WHO and other stakeholders should consider two main categories of drug quality problems. Falsified medicines misrepresent the product’s identity or source or both. Substandard drugs fail to meet the national specifications given in an accepted pharmacopeia or the manufacturer’s dossier. In practice, there is often considerable overlap between categories.
There is considerable uncertainty about the size of the falsified and substandard drug market. Improved pharmacovigilance, especially in developing countries, give a better picture of the scope of the problem. In the United States, tighter regulatory controls on the wholesale market and a mandatory drug tracking system would improve drug safety. In developing countries, development finance organizations should invest in small- and medium-sized pharmaceutical manufacturers, and governments should use tools such as franchising, accreditation, low-interest loans, and task shifting to encourage private sector investment in drug retail. Finally, the WHO should work with stakeholders such as the UNODC and the WCO to develop an international code of practice on falsified and substandard drugs
Countering the Problem of Falsified and Substandard Drugs
No full textThe adulteration and careless manufacture of medicines is an old problem, vastly aggravated by globalization. The US Food and Drug Administration commissioned the Institute of Medicine to investigate the global problem of falsified and substandard drugs, considering the causes and possible solutions to this international public health crisis. In its consensus report, the committee identified two main categories of drug quality failures of public health concern. Falsified drugs carry a false representation of identity or source; substandard drugs fail to meet the specifications set in the national pharmacopeia or the manufacturer’s dossier. In practice, these categories overlap, but they are sufficiently precise for public discourse.
It is difficult to measure the global market for falsified and substandard drugs, but there is good evidence that they are a problem in poor countries with weak drug regulatory systems. All classes of drugs are compromised, especially inexpensive antibacterial and antimalarial treatments. When fake antimicrobials contain sub-therapeutic doses of active ingredients, they encourage drug resistance, shortening the effective life of a drug and hastening the expense of new drug development. The trade in fake medicines erodes patient confidence in allopathic medicine and the public health system. The organized fraud that allows the drugs to circulate undermines all public institutions and conveys money and power to criminals.
Investment in drug manufacturing could improve drug quality in low- and middle-income countries, and development finance organizations are well positioned to make these investments. Changes to procurement practices could also help guarantee that honest manufacturers get the largest market share. Most of all, low- and middle-income countries need better regulatory systems. The first step to building these systems is developing a strategic plan for the agency improvement. Changes to the drug distribution system could protect the drugs supply. In the United States, licensing only wholesalers that meet National Association of Boards of Pharmacy accreditation standards would reduce the hazards of secondary wholesale, as would a congressionally mandated track-and-trace system. In developing countries, governments should use franchising, accreditation, low-interest loans, and task shifting to create an environment conducive to quality drug retail. There is also a need for sturdy and inexpensive detection technologies that can be used to detect fake medicines in the field. A WHO International Code of Practice on falsified and substandard drugs would facilitate international cooperation against falsified and substandard drugs
Natalie Stoljar’s Wishful Thinking and One Step Beyond: What Should Conceptual Legal Analysis Become?
Get PDFPraising wishful thinking is a serious risk that the author is willing to run not only in this article commenting of Natalie Stoljar’s work but also elsewhere in his scholarship. The author will analyze her claims and will agree mostly with them, he will also criticize her for stopping one step short adopting the desirability or weaker claim, when in it is not merely possible but necessary to go one step beyond arguing for the necessity or stronger claim. The author intends to present further grounds for endorsing “conceptual (legal) analysis pluralism” by distinguishing the three different inquiry or projects that are and must be integrated and stating the normative priority of one of them, i.e. the prescriptive, interpretive, and moral
Grades Matter; Legal Writing Grades Matter Most
Get PDFIn this study of 380 students in a law school’s 2011 graduating class, the data demonstrates a strong correlation between high performance in legal writing courses and high performance in non-legal writing courses. There is also a strong correlation at the opposite end: low performers in legal writing courses are low performers in non-legal writing courses. This article provides the hard data to support the significance of writing skills by demonstrating the correlation between performance in legal writing courses and performance in other law school courses by comparing grades and Grade Point Averages (GPAs). Of course grades and GPA data are not the sole measures of success, but as other research has indicated, good grades often translate to job interviews, job offers, and ultimately, jobs—the true measure of success these days.
With the changing economy, declining employment statistics, downsizing legal employment market, increasing tuition at rates exceeding inflation, and a declining law school applicant pool, legal education cannot simply stand by and hope things get better. Information about how performance in legal writing correlates to law school performance outside of the legal writing course is nowhere close to curing any of these ills. Such information is, however, useful for schools in thinking about how to move forward. Slow as it may be to come or as difficult to manage, law schools must react to these and other changes; part of that reaction should include curricular reform that better prepares students for success—with success defined as after-graduation employment. To aid law schools in thinking about curricular reform, this article proves what legal writing professors and legal education reformers have known for a long time: legal writing courses are the linchpin of legal education
Book Review of \u3ci\u3eThe Impossible State\u3c/i\u3e by Wael Hallaq
Get PDFIn his book The Impossible State, Wael Hallaq argues that the modern state is a bad fit for Muslims. This is so because the paradigm of “Islamic Governance”, developed through centuries of Islamic rule, and the modern state of the West are incompatibles if not altogether contradictory. The modern state, a European invention and an expression of the unique unfolding of Europe’s history, being premised on the deep penetration by the nation state of its population, a separation of powers between the executive, legislative and the judiciary that is always faltering, a separation between the is and the ought and the primacy of the political over everything else goes against the very grain of the Islamic non-state. The latter, by contrast according to Hallaq, is organized organically around the center of God’s sovereignty, Sharia being the moral code, the privileged expression of His Will. The translation of Sharia the moral code into law unfolds through the work of a learned juristic class that acts as mediator between the community, to which the jurists are organically connected, and God the sovereign. The world of Islam is moral by excellence that rejects the separation between fact and norm, for whom the “political” is confined to executive rulers of rotating dynasties that remain external to the embryonic tight embrace between jurists and community, whose role is to tax, organize armies, and regulate on the margins. In this universe, the “the care of the self” by the individual Muslim to fashion oneself as moral according to the dictates of the Sharia is the organizing principle of life, which is in contradistinction to the pitiable plight of the modern Western citizen whose subjectivity is fashioned by the state for its own selfish utilitarian ends. Pulling a Huntington-inreverse, Hallaq argues that not only the modern state thrown by Europe into Muslim shores by force a bad fit for Muslims, it is decidedly inferior to the counter model of Islamic governance. For Muslims, due to their “paradigm” of governance, had lived in peace and tranquility for centuries, spared the revolutions and tumults of Europe, as they had been historically free of the tyranny of monarchs, the cruelty of feudalism and the abuses of the church, all of which had forced their European compatriots to rebel!
Hallaq ends by on the one hand inviting the West to recognize the radical-ness of the Muslim other and to give up its imposed universalisms. Indeed, he invites the West to open its heart and mind to the Islamic model, for who knows it might learn to be enlightened by it. On the other, he expresses skepticism of contemporary projects of Islamic reconstruction of law such as Islamic finance because the modern state is the background assumption and the locus for such projects. The problem according to Hallaq is that such attempts proceed to reconstruct law while leaving aside the reconstruction of the moral Muslim who Islamic governance assumed to be the ontological prior to law and litigation. Deprived of the moral context that lend them the quality “Islamic” such projects are either inauthentically so or are doomed to failure
Guiding Section 5: Comments on the Commissioners
Get PDFFTC Commissioners Joshua Wright and Maureen Ohlhausen have proposed that the Commission adopt Guidelines for the application of Section 5 to Unfair Methods of Competition. This short note comments on the role of Section 5 distinct from the Sherman Act. It suggests that Section 5 be used to attack and deter certain conduct that falls into gaps of the Sherman Act. This includes exclusionary unilateral conduct that likely leads to the achievement, enhancement, or maintenance of market power (as opposed to monopoly power). It also includes unilateral conduct such as invitations to collude and other practices that facilitate conscious parallelism, tacit or express collusion, but are not uniquely or sufficiently “unequivocal” or “consequential” to violate Section 2. The comment also explains why a limitation of Section 5 only to conduct with zero cognizable efficiency benefits would neutralize Section 5 and lead to under-deterrence problems and why a disproportionate harm standard also is problematical
Neo-Democracy, National Security, and Liberty
Get PDFIn his new book, Liberty and Security, Conor Gearty, professor of law at the London School of Economics and one of the United Kingdom’s leading authorities on civil liberties and national security, argues that many Western nations are in effect “neo-democracies” that fail systematically to live up to the fundamental egalitarian premises of true democracy, and that this development is seen in particular in the context of counter-terrorism policy. This review assesses that claim, and maintains that while Gearty is correct that many counter-terrorism measures are predicated on double standards, that critique is insufficient to answer the many difficult questions that national security efforts raise, even in the absence of discrimination. Thus, while a universalist critique is an important element in assessing the status of human rights in the context of national security measures, the demand for universal protection of human rights does not answer when a targeted killing might be lawful, or how best to preserve privacy in the digital age from mass surveillance of the sort Edward Snowden has revealed. Gearty’s book perspicaciously identifies a transnational phenomenon and a critical problem in many counter-terrorism policies and practices, but the universalist critique still leaves many questions unresolved
Changing Climate for Carbon Taxes: Who’s Afraid of the WTO?
Get PDFCarbon taxes have recently become a major source of discussion in the Washington, DC policy community. Supporters contend that they offer an efficient way to simultaneously create incentives to emit less carbon dioxide and reduce the budget deficit. Leading think tanks from both the left and the right, including Brookings, the American Enterprise Institute, and Resources for the Future, have hosted dialogues on how to structure the tax and use the revenues. Meanwhile, lawmakers have proposed two carbon tax bills during this congressional session: 1) Senators Boxer (D-CA) and Sanders (I-VT) put forward a plan to assess coal, oil, and gas producers a 15 and $30 per ton on greenhouse gas emissions from power plants, factories, refineries, and other major emitters of carbon dioxide.
Should such a carbon tax be enacted, it will in all likelihood be accompanied by measures to ensure that the U.S. industries that would be most heavily affected by the tax are not placed at a competitive disadvantage with respect to competitor producers operating in countries that have not imposed any restrictions or taxes on carbon usage. Any such efforts to “level the playing field” will raise numerous questions regarding their compatibility with U.S. international obligations, especially their legality under agreed upon rules of the World Trade Organization (WTO) and in particular, the General Agreement on Tariffs and Trade (GATT).
Can such a carbon tax be applied in a way that does not violate U.S. obligations under the WTO Agreements? I believe the answer is yes, provided that policymakers carefully design such a tax, keeping in mind the basic requirements of the WTO not to discriminate in favor of domestic producers or to favor imports from certain countries over others. The key is to structure any accompanying border measure as a straightforward extension of the domestic climate policy to imports. If so designed, there should be few questions about the measure’s consistency with the WTO rules. Even if questions were raised, the United States would have strong defenses within the WTO system. And even if those defenses were somehow to fail, the United States would be able to make adjustments should some aspect of its carbon tax system be found wanting. A non-discriminatory tax enacted in good faith to address climate change should pass muster with the WTO. Therefore, the threat of WTO challenges should not deter policymakers from adopting a carbon tax system now