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Freedom Not To See A Doctor: The Path Toward Over-The-Counter Abortion Pills, Lewis Grossman
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, …
Not So Juris-Prudent: The Misguided Movement To Abandon Chevron Deference Through The Lens Of Mifepristone And The Attacks On Fda Autonomy, Ella Seltzer
Upper Level Writing Requirement Research Papers
No abstract provided.
Please Consult Your Lawyer Before Taking Sorrell: How The Fda Should Approach Social Media For Prescription Drug Advertising, Steven Valentino
Please Consult Your Lawyer Before Taking Sorrell: How The Fda Should Approach Social Media For Prescription Drug Advertising, Steven Valentino
Upper Level Writing Requirement Research Papers
No abstract provided.
Supply And Demand: Navigating Emergency Regulatory Developments In The Fight Against Opioid Use Disorder, Eva Bogdewic
Supply And Demand: Navigating Emergency Regulatory Developments In The Fight Against Opioid Use Disorder, Eva Bogdewic
Upper Level Writing Requirement Research Papers
No abstract provided.
Life, Liberty, [And The Pursuit Of Happiness]: Medical Marijuana Regulation In Historical Context, Lewis Grossman
Life, Liberty, [And The Pursuit Of Happiness]: Medical Marijuana Regulation In Historical Context, Lewis Grossman
Articles in Law Reviews & Other Academic Journals
The struggle for access to medical marijuana differs from most other battles for therapeutic freedom in American history because marijuana also has a popular, though controversial, nontherapeutic use—delivery of a recreational high. After considering struggles over the medical use of alcohol during prohibition as a precedent, this chapter relates the history of medical marijuana use and regulation in the United States. The bulk of the chapter focuses on the medical marijuana movement from the 1970s to present. This campaign has been one of the prime examples of a successful extrajudicial social movement for freedom of therapeutic choice. With the exception …
Enforcement Discretion Under Attack: Implications For Fda, Lewis Grossman
Enforcement Discretion Under Attack: Implications For Fda, Lewis Grossman
Articles in Law Reviews & Other Academic Journals
Author's Note: On June 23, as this article was going to press, the Supreme Court deadlocked 4-4 in U.S. v. Texas, thus affirming a preliminary injunction against implementation of the Obama Administration’s deferred-action program for millions of undocumented immigrants. Because the Court’s terse per curiam decision established no precedent, the questions that the case raised regarding the permissible scope of administrative enforcement discretion remain unresolved on the national level. The Supreme Court will likely consider them again—after a decision on a permanent injunction in the same case, in a similar immigration dispute, or perhaps in another field of administrative law. …
Aids Activists, Fda Regulation, And The Amendment Of America's Drug Constitution, Lewis Grossman
Aids Activists, Fda Regulation, And The Amendment Of America's Drug Constitution, Lewis Grossman
Articles in Law Reviews & Other Academic Journals
This Article explores how AIDS activists, desperate for access to potentially life-saving pharmaceuticals, permanently transformed America’s “drug constitution.” Their advocacy altered the FDA’s interpretation and application of the federal Food, Drug, and Cosmetic Act (FDCA) so as to expedite the availability of new, unproven drugs for critical illnesses, thus enhancing individual patients’ autonomy to make therapeutic choices without government interference.The FDCA is more than simple set of instructions to a federal agency — it is a source of vitally important and deeply entrenched institutional and normative frameworks. Like major civil rights, antitrust, and environmental statutes, the FDCA should be viewed …
The Fda And The Rise Of The Empowered Patient, Lewis Grossman
The Fda And The Rise Of The Empowered Patient, Lewis Grossman
Contributions to Books
No abstract provided.
Fda And The Rise Of The Empowered Consumer, Lewis Grossman
Fda And The Rise Of The Empowered Consumer, Lewis Grossman
Articles in Law Reviews & Other Academic Journals
This Article traces the still-evolving view of consumers of FDA-regulated products as capable, rational, and rights-bearing decision makers. It also examines the corresponding diminution of FDA’s role as a paternalistic gatekeeper collaborating with medical and scientific experts to prevent products and manufacturer-provided information from reaching the public. Compared with their 1960s counterparts, today’s consumers of food and drugs have far greater freedom to make unmediated choices among a wider variety of products, guided by a relative deluge of labeling and advertising information. Moreover, food and drug regulation, once the exclusive domain of bureaucrats and experts, has become a focus of …
Livestock Animal Cloning: This Steak Is Giving Me Déjà Vu, Blake M. Mensing
Livestock Animal Cloning: This Steak Is Giving Me Déjà Vu, Blake M. Mensing
Sustainable Development Law & Policy
No abstract provided.
Food, Drugs, And Droods: A Historical Consideration Of Definitions And Categories In American Food And Drug Law, Lewis Grossman
Food, Drugs, And Droods: A Historical Consideration Of Definitions And Categories In American Food And Drug Law, Lewis Grossman
Articles in Law Reviews & Other Academic Journals
This article explores the development and interaction of the legal and cultural categories food and drug from the late nineteenth century to the present. It is based not only on legal and historical research, but also on theories of category formation from the fields of linguistics and psychology.The scope of the Food and Drug Administration's power is defined primarily by the list of product categories over which it has jurisdiction. The statutory definitions of these categories (food, drug, cosmetic, device, and human biological product) thus delineate the outer boundaries of the arena within which the agency operates. The definitions are …
Preparing For The Unknown: The Threat Of Agroterrorism, Matthew Padilla
Preparing For The Unknown: The Threat Of Agroterrorism, Matthew Padilla
Sustainable Development Law & Policy
No abstract provided.
Fda Jurisdiction: A Matter Of Definitions, Lewis Grossman
Fda Jurisdiction: A Matter Of Definitions, Lewis Grossman
Contributions to Books
This chapter, new in the third edition, concerns how Congress, the Food and Drug Administration, and the courts have treated the definitions of "food," "drug," "cosmetic," "device," and "human biological product." The scope of FDA's power is delineated almost entirely by the list of product categories over which it has jurisdiction. As the materials in this chapter show, the product definitions are strikingly broad and thus confer jurisdiction over a vast range of goods. Furthermore, the definitions are remarkably plastic, providing FDA with great flexibility to decide whether and how to regulate products. Sometimes FDA has interpreted the definitions expansively, …