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Food and Drug Law

American University Washington College of Law

Food and Drug Law

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Freedom Not To See A Doctor: The Path Toward Over-The-Counter Abortion Pills, Lewis Grossman Jan 2023

Freedom Not To See A Doctor: The Path Toward Over-The-Counter Abortion Pills, Lewis Grossman

Articles in Law Reviews & Other Academic Journals

American courts and lawmakers are engaged in an epic struggle over the fate of abortion pills. While some anti-abortion activists are attempting to drive the pills off the market entirely, supporters of reproductive rights are striving to make them more easily accessible. This Article advances the latter mission with a bold proposal: FDA should consider allowing abortion pills to be sold over the counter (OTC). Abortion rights supporters argue that FDA should repeal the special distribution and use restrictions it unnecessarily imposes on mifepristone, one of two drugs in the medication abortion regimen. Even if FDA removed these restrictions, however, …


One Size Does Not Fit All, David Spratt Jan 2012

One Size Does Not Fit All, David Spratt

Articles in Law Reviews & Other Academic Journals

No abstract provided.


An Economic Justification For Open Access To Essential Medicine Patents In Developing Countries, Sean Flynn, Aidan Hollis, Mike Palmedo Jan 2009

An Economic Justification For Open Access To Essential Medicine Patents In Developing Countries, Sean Flynn, Aidan Hollis, Mike Palmedo

Articles in Law Reviews & Other Academic Journals

This paper offers an economic rationale for compulsory licensing of needed medicines in developing countries. The patent system is based on a trade-off between the “deadweight losses” caused by market power and the incentive to innovate created by increased profits from monopoly pricing during the period of the patent. However, markets for essential medicines under patent in developing countries with high income inequality are characterized by highly convex demand curves, producing large deadweight losses relative to potential profits when monopoly firms exercise profit-maximizing pricing strategies. As a result, these markets are systematically ill-suited to exclusive marketing rights, a problem which …


Judicial Review Of Fda Preemption Determinations, Amanda Frost Jan 1999

Judicial Review Of Fda Preemption Determinations, Amanda Frost

Articles in Law Reviews & Other Academic Journals

No abstract provided.


Anatomy Of A Regulatory Program: Comment On 'Strategic Regulators And The Choice Of Rulemaking Procedures', Jeffrey Lubbers Jan 1994

Anatomy Of A Regulatory Program: Comment On 'Strategic Regulators And The Choice Of Rulemaking Procedures', Jeffrey Lubbers

Articles in Law Reviews & Other Academic Journals

Besides being a very interesting, cogent, and even a tidy study, "Strategic Regulators" sheds some bright light on agency behavior and on the important issue of whether agency rulemaking may be "ossifying."

The study design employed by Hamilton and Schroeder is attractively simple. They started with all of the Environmental Protection Agency's ("EPA's") hazardous waste regulations under the Resource Conservation and Recovery Act ("RCRA") appearing in the Code of Federal Regulations ("CFR"), counting each decimal point CFR number as a separate rule. This yielded 697 rules. They then examined all EPA/RCRA guidance documents issued since the inception of the program …