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Articles 1 - 15 of 15
Full-Text Articles in Food and Drug Law
Abortion Pills, David S. Cohen, Greer Donley, Rachel Rebouché
Abortion Pills, David S. Cohen, Greer Donley, Rachel Rebouché
Articles
Abortion is now illegal in roughly a third of the country, but abortion pills are more widely available than ever before. Though antiabortion advocates and legislators are attacking pills with all manner of strategies, clinics, websites, and informal networks are openly facilitating the distribution of abortion pills, legally and illegally, across the United States. This Article is the first to explain this defining aspect of the post-Roe environment and the novel issues it raises at the level of state law, federal policy, and on-the-ground advocacy.
This Article first details antiabortion strategies to stop pills by any means necessary. These tactics …
Medication Abortion Exceptionalism, Greer Donley
Medication Abortion Exceptionalism, Greer Donley
Articles
Restrictive state abortion laws garner a large amount of attention in the national conversation and legal scholarship, but less known is a federal abortion policy that significantly curtails access to early abortion in all fifty states. The policy limits the distribution of mifepristone, the only drug approved to terminate a pregnancy so long as it is within the first ten weeks. Unlike most drugs, which can be prescribed by licensed healthcare providers and picked up at most pharmacies, the Food and Drug Administration only allows certified providers to prescribe mifepristone, and only allows those providers to distribute the drug to …
Regulation Of Encapsulated Placenta, Greer Donley
Regulation Of Encapsulated Placenta, Greer Donley
Articles
The practice of placenta encapsulation is rapidly growing. It typically involves post-partum mothers consuming their placentas as pills in the months after childbirth. The perceived benefits include improved mood and energy, reduced bleeding and pain, and greater milk supply. But these effects are unproven, and consumption comes with health risks. The rise of this trend has sparked a vigorous debate in the recent medical literature, but this Article is the first to consider the legal implications of placenta encapsulation. This Article examines whether FDA should regulate encapsulated placenta, and if so, whether it should be regulated as a drug, supplement, …
Drug Approval In A Learning Health System, W. Nicholson Price
Drug Approval In A Learning Health System, W. Nicholson Price
Articles
The current system of FDA approval seems to make few happy. Some argue FDA approves drugs too slowly; others too quickly. Many agree that FDA—and the health system generally—should gather information after drugs are approved to learn how well they work and how safe they are. This is hard to do. FDA has its own surveillance systems, but those systems face substantial limitations in practical use. Drug companies can also conduct their own studies, but have little incentive to do so, and often fail to fulfil study commitments made to FDA. Proposals to improve this dynamic often suggest gathering more …
Value Hypocrisy And Policy Sincerity: A Food Law Case Study, Joshua Galperin
Value Hypocrisy And Policy Sincerity: A Food Law Case Study, Joshua Galperin
Articles
It is tempting to say that in 2017 there is a unique problem of hypocrisy in politics, where words and behaviors are so often in opposition. In fact, hypocrisy is nothing new. A robust legal and psychological literature on the importance of procedural justice demonstrates a longstanding concern with developing more just governing processes. One of the important features of this scholarship is that it does not focus only on the consequences of policymaking, in which behaviors, but not words, are relevant. Instead, it respects the intrinsic importance of fair process, lending credence not only to votes but also to …
Manufacturing Barriers To Biologics Competition And Innovation, W. Nicholson Price Ii., Arti K. Rai
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 …
Encouraging Maternal Sacrifice: How Regulations Governing The Consumption Of Pharmaceuticals During Pregnancy Prioritize Fetal Safety Over Maternal Health And Autonomy, Greer Donley
Articles
Pregnant women are routinely faced with the stressful decision of whether to consume needed medications during their pregnancies. Because the risks associated with pharmaceutical drug consumption during pregnancy are largely unknown, pregnant women both inadvertently consume dangerous medications and avoid needed drugs. Both outcomes are harmful to pregnant women and their fetuses. This unparalleled lack of drug safety information is a result of ill-conceived, paternalistic regulations in two areas of the law: regulations governing ethical research in human subjects and regulations that dictate the required labels on drugs. The former categorizes pregnant women as “vulnerable” and thus precludes them from …
A System Of Men And Not Of Laws: What Due Process Tells Us About The Deficiencies In Institutional Review Boards, Greer Donley
A System Of Men And Not Of Laws: What Due Process Tells Us About The Deficiencies In Institutional Review Boards, Greer Donley
Articles
Governmental regulation of human subjects research involves unique agency action. It delegates power to non-expert committees, Institutional Review Boards, to decide whether research protocols are "ethical" according to vague federal regulations. Without IRB approval, the protocol cannot be investigated. The empirical evidence regarding this system demonstrates that IRBs render deeply inconsistent and inaccurate outcomes. This Article argues that the lack of due process in the IRB system is to blame for such arbitrary agency action. By juxtaposing the levels of process required for IRB approval or research with FDA new drug approval--agency action involving similar interests--this Article highlights that IRBs …
A Response To Professor Leff’S Tax Planning 'Olive Branch' For Marijuana Dealers, Philip Hackney
A Response To Professor Leff’S Tax Planning 'Olive Branch' For Marijuana Dealers, Philip Hackney
Articles
Professor Benjamin Leff argues in a forthcoming article entitled Tax Planning for Marijuana Dealers that a tax-exempt social welfare organization described in Internal Revenue Code section 501(c)(4) may sell medical marijuana without putting its exempt status in jeopardy. He argues that (1) the “public policy” doctrine applicable to charitable organizations under section 501(c)(3) does not apply to social welfare organizations, and (2) a social welfare organization may consider “community” law and ignore federal law in considering whether its activity meets the idea of social welfare. I argue that Leff is wrong and that the public policy doctrine applicable to charitable …
Two Masters, Carl E. Schneider
Two Masters, Carl E. Schneider
Articles
American government rests on the principle of distrust of government. Not only is power within the federal government checked and balanced. Power is divided between the federal government and the state governments. So what if a state law conflicts with a federal law? The Constitution says that the "Constitution, and the Laws of the United States ... shall be the supreme Law of the Land; ... any Thing in the ... Laws of any State to the Contrary notwithstanding." Sometimes the conflict between federal and state law is obvious and the Supremacy Clause is easily applied. But sometimes ...
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 …
Smokers' Compensation: Toward A Blueprint For Federal Regulation Of Cigarette Manufacturers, Jon D. Hanson, Kyle D. Logue, Michael S. Zamore
Smokers' Compensation: Toward A Blueprint For Federal Regulation Of Cigarette Manufacturers, Jon D. Hanson, Kyle D. Logue, Michael S. Zamore
Articles
Although nothing is certain in Washington, sweeping federal legislation in the cigarette area is more likely now than has ever been the case. Congress is currently considering several proposals for comprehensive federal regulation of the cigarette market, a market that has until now gone largely untouched by government intervention. Among those proposals, the one that has received the most attention, and the one that in fact motivated policy makers to look anew at the problems posed by cigarettes, is the proposed national tobacco resolution (the "Proposed Resolution"). The Proposed Resolution, which has been advanced by a coalition of state attorneys …
A Critique Of The Proposed National Tobacco Resolution And A Suggested Alternative, Jon D. Hanson, Kyle D. Logue
A Critique Of The Proposed National Tobacco Resolution And A Suggested Alternative, Jon D. Hanson, Kyle D. Logue
Articles
The first criticism is that the proposed resolution would not require manufacturers and, in tum, consumers to pay anything approaching the true total costs of cigarettes, costs that we estimate to be at least $7 per pack, a number that is considerably higher than other estimates that have been reported in the media. Our estimate includes some, but not all, of the costs borne ultimately by smokers themselves, by smokers' insurers, and by individuals injured by second-hand smoke. It includes only future costs and excludes many of those. So, for example, the figure includes neither the health-care costs that have …
The Costs Of Cigarettes: The Economic Case For Ex Post Incentive-Based Regulation, Jon D. Hanson, Kyle D. Logue
The Costs Of Cigarettes: The Economic Case For Ex Post Incentive-Based Regulation, Jon D. Hanson, Kyle D. Logue
Articles
Cigarette smoking causes over 420,000 deaths annually in the United States, roughly twenty percent of all U.S. deaths, making cigarettes the single greatest preventable cause of death in this country. Indeed, tobacco kills more people every year than alcohol, illicit drugs, automobile accidents, violent crime, and AIDS combined. And not only are cigarettes deadly to smokers; they kill nonsmokers as well. According to a recent report from the Environmental Protection Agency (EPA), the "sidestream" or "passive" smoke from cigarettes - so-called environmental tobacco smoke (ETS) - is responsible annually for approximately 3000 lung cancer deaths, between 150,000 and 300,000 lower …