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Articles 1 - 19 of 19
Full-Text Articles in Law
International Reciprocity: If A Drug Is Good Enough For Great Britain, It Should Be Good Enough For The United States, Nicole C. Perez
International Reciprocity: If A Drug Is Good Enough For Great Britain, It Should Be Good Enough For The United States, Nicole C. Perez
University of Miami Business Law Review
The pharmaceutical industry is one of the largest, and most lucrative, industries in the world, worth about one trillion U.S. dollars. Specifically, the United States accounts for more than one-third of the global pharmaceutical market with about 340 million dollars in sales. Not only is the pharmaceutical industry one of the biggest industries profit-wise, but it is also an industry that affects almost every single person in the world. In a nation where healthcare issues are always on the rise, ensuring that American citizens benefit from pharmacology is essential to improving the nation’s healthcare system. The Food and Drug Administration …
Regulating Off-Label Promotion — A Critical Test, Christopher Robertson, Aaron S. Kesselheim
Regulating Off-Label Promotion — A Critical Test, Christopher Robertson, Aaron S. Kesselheim
Faculty Scholarship
In 2012, the U.S. Court of Appeals for the Second Circuit handed down a landmark decision in the case of pharmaceutical sales representative Alfred Caronia. The Food and Drug Administration (FDA) had approved sodium oxybate (Xyrem) for treating narcolepsy, but Caronia promoted it for a wide range of nonapproved (off-label) indications, including insomnia, Parkinson’s disease, and fibromyalgia. Off-label use is common, especially in specialties such as oncology, in which it may even be considered the standard of care. However, surveys have revealed that supporting evidence is lacking for a majority of off-label uses of medical products.1 The uses Caronia …
Ebola, Experimental Medicine, Economics, And Ethics: An Evaluation Of International Disease Outbreak Law, Sara L. Dominey
Ebola, Experimental Medicine, Economics, And Ethics: An Evaluation Of International Disease Outbreak Law, Sara L. Dominey
Georgia Journal of International & Comparative Law
No abstract provided.
Science, Public Bioethics, And The Problem Of Integration, O. Carter Snead
Science, Public Bioethics, And The Problem Of Integration, O. Carter Snead
O. Carter Snead
Public bioethics — the governance of science, medicine, and biotechnology in the name of ethical goods — is an emerging area of American law. The field uniquely combines scientific knowledge, moral reasoning, and prudential judgments about democratic decision making. It has captured the attention of officials in every branch of government, as well as the American public itself. Public questions (such as those relating to the law of abortion, the federal funding of embryonic stem cell research, and the regulation of end-of-life decision making) continue to roil the public square. This Article examines the question of how scientific methods and …
Litigating Medical Device Premarket Classification Decisions For Small Businesses: Have The Courts Given The Fda Too Much Deference? The Case For Taking The Focus Off Of Efficacy, Stephanie P. Fekete
Litigating Medical Device Premarket Classification Decisions For Small Businesses: Have The Courts Given The Fda Too Much Deference? The Case For Taking The Focus Off Of Efficacy, Stephanie P. Fekete
Catholic University Law Review
The manufacturing of innovative medical devices is important for the continued success and growth of the U.S. health care system and economy. The medical device industry is almost exclusively comprised of small businesses. The U.S. Food and Drug Administration (FDA) regulates the medical device industry and employs a rigorous approval process to determine when products may enter the market. While the FDA’s goal is to authorize the sale of innovative devices that are safe for patient use, device manufacturers argue that the process to obtain FDA approval is unnecessarily expensive, burdensome, and has systemic problems. As a result of the …
It’S Time For The Fda To Define ‘Natural’, Jason J. Czarnezki
It’S Time For The Fda To Define ‘Natural’, Jason J. Czarnezki
Elisabeth Haub School of Law Faculty Publications
The authors discusses the FDA 's recent call for comments on a definition of the term natural as it applies to food.
Placebo Patents: Creating Stronger Intellectual Property Protection For Pharmaceuticals Approved By The U.S. Food & Drug Administration, Sarah Renee Craig
Placebo Patents: Creating Stronger Intellectual Property Protection For Pharmaceuticals Approved By The U.S. Food & Drug Administration, Sarah Renee Craig
Journal of Intellectual Property Law
No abstract provided.
Discrimination And Business Regulation, Eileen Kaufman
Discrimination And Business Regulation, Eileen Kaufman
Touro Law Review
No abstract provided.
A Pharmaceutical Park Place: Why The Supreme Court Should Modify The Scope Of The Patent Test For Reverse Payment Deals, David Ernest Balajthy
A Pharmaceutical Park Place: Why The Supreme Court Should Modify The Scope Of The Patent Test For Reverse Payment Deals, David Ernest Balajthy
Journal of Intellectual Property Law
No abstract provided.
Regulating Healthcare Robots: Maximizing Opportunities While Minimizing Risks, Drew Simshaw, Nicolas Terry, Kris Hauser, M.L. Cummings
Regulating Healthcare Robots: Maximizing Opportunities While Minimizing Risks, Drew Simshaw, Nicolas Terry, Kris Hauser, M.L. Cummings
Richmond Journal of Law & Technology
Some of the most dynamic areas of robotics research and development today are healthcare applications. Robot-assisted surgery, robotic nurses, in-home rehabilitation, and eldercare robots' are all demonstrating rapidly iterating innovation. Rising healthcare labor costs and an aging population will increase demand for these human surrogates and enhancements. However, like many emerging technologies, robots are difficult to place within existing regulatory frameworks. For example, the federal Food, Drug, and Cosmetic Act (FD&C Act) seeks to ensure that medical devices (few of which are consumer devices) are safe, the HIPAA Privacy and Security Rules apply to data collected by health care providers …
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. …
The Law Of 180-Day Exclusivity, Erika Lietzan, Julia Post
The Law Of 180-Day Exclusivity, Erika Lietzan, Julia Post
Faculty Publications
In 1984, Congress created a statutory pathway for approval of generic drug applications and included an incentive for generic applicants to challenge the patents claiming the reference drugs on which they based their applications. The first generic applicant to file an ANDA with a patent challenge is eligible for 180 days of generic market exclusivity. This article is the fourth in a series of articles describing the resulting body of law, as interpreted and applied by FDA (in regulations, guidances, citizen petition responses, and individual decisions awarding and denying exclusivity) and the courts. The heart of the article is section …
Tainted: Food, Identity, And The Search For Dignitary Redress, Melissa Mortazavi
Tainted: Food, Identity, And The Search For Dignitary Redress, Melissa Mortazavi
Brooklyn Law Review
The law recognizes a right to legal redress for exposure to food that is tainted in the sense of being toxic or poisonous, but what about exposure to food products individuals find socially, morally, or religiously repugnant? Jews eating “kosher” hot dogs containing standard non-kosher meats. Vegetarians fed beef. Muslims ingesting vitamins containing pork. Aren’t these food products also “tainted”? Despite the fact that the American legal system has long recognized the need to protect individual dignitary rights, the law provides little meaningful redress in these situations or other instances of offensive food taint. So why has food autonomy, an …
The Scope Of Preemption Under The 2009 Family Smoking Prevention And Tobacco Control Act, Sam F. Halabi
The Scope Of Preemption Under The 2009 Family Smoking Prevention And Tobacco Control Act, Sam F. Halabi
Faculty Publications
The 2009 Family Smoking Prevention and Tobacco Control Act endeavored to alter the regulatory regime for tobacco products in the United States by allocating authority to regulate tobacco products to the U.S. Food and Drug Administration (FDA). While the law aims at greater transparency in the constituent components of cigarettes and non-combustible tobacco products, it also includes a provision which will bring FDA’s consumer protection and tobacco control mandates into tension: Section 911’s process for the approval of modified risk tobacco products. That provision allows tobacco manufacturers to submit applications to label products as “reduc[ing] the harm or the risk …
State 'Right To Try' Acts: A Good Start, But A Federal Act Is Necessary, Ellen A. Black
State 'Right To Try' Acts: A Good Start, But A Federal Act Is Necessary, Ellen A. Black
Law Faculty Scholarship
In an effort to help terminally ill patients bypass the FDA's arduous, time-consuming approval process and have quicker access to potentially life-saving drugs, states across the country have passed "right to try" acts. These state acts allow a terminally ill patient the right to access an investigational drug that has completed initial safety testing, known as Phase I, but that has not been approved by the FDA. The reasoning behind these acts is that terminally ill patients, with the guidance and counsel of their physicians, should have the choice whether to pursue an unapproved drug, rather than placing their fate …
Off-Label Drug Marketing, The First Amendment, And Federalism, David Orentlicher
Off-Label Drug Marketing, The First Amendment, And Federalism, David Orentlicher
Scholarly Works
In this article, Professor Orentlicher explores free speech and federalism issues arising from FDA regulation of off-label uses and off-label marketing of drugs. In light of the FDA's desire to respect state government authority, together with other considerations discussed in this article, he argues for the rejection of the analysis of the Caronia court and to give the FDA significant leeway in its regulation of off-label marketing.
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 …
Fda's Troubling Failures To Use Its Authority To Regulate Genetically Modified Foods, Leslie Francis, Robin Kundis Craig, Erika George
Fda's Troubling Failures To Use Its Authority To Regulate Genetically Modified Foods, Leslie Francis, Robin Kundis Craig, Erika George
Faculty Scholarship
This Article concerns the particular regulatory responsibilities only of FDA. It sets to one side the possible regulatory authority of agencies such as the Environmental Protection Agency ("EPA") or the U.S. Department of Agriculture ("USDA"). This approach risks replicating the regulatory fracture introduced during the Reagan Administration and criticized by some scholars,15 but there is a great deal to say about current FDA practices. Out of similar considerations of space and focus, this Article also sets to one side many other important issues that surround GM foods: intellectual property rights; rights to free speech or commercial speech; fair trade …
A New Governance Recipe For Food Safety Regulation, Alexia Brunet Marks
A New Governance Recipe For Food Safety Regulation, Alexia Brunet Marks
Publications
Although food safety is a significant and increasing global health concern, international economic law does not adequately address today’s global food safety needs. While most countries rely on a collection of formalized legal rules to protect food safety, these rules too often fall short. As fiscal constraints impede raising the number of border inspections, formal international commitments (treaties) frequently limit governmental efforts to raise food safety standards. Private companies, meanwhile, can readily adopt higher standards to meet consumer demands and supply chain needs, thus demonstrating more nimbleness and flexibility in adopting the highest food safety standards available. Can countries learn …