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Articles 31 - 60 of 72
Full-Text Articles in Food and Drug Law
Peru's Too Expensive - I'Ll Get My Cheese From Chile: The Agricultural Market Access Provisions Of The U.S.-Chile Fta And The U.S.-Peru Tpa, Guillermo Gabriel Zorogastua
Peru's Too Expensive - I'Ll Get My Cheese From Chile: The Agricultural Market Access Provisions Of The U.S.-Chile Fta And The U.S.-Peru Tpa, Guillermo Gabriel Zorogastua
Florida State University Journal of Transnational Law & Policy
No abstract provided.
Improving The Pharmaceutical Industry:Optimality Inside The Framework Of The Current Legal System Provides Access To Medicines For Hiv/Aids Patients In Sub-Saharan Africa, Gourav N. Mukherjee
Improving The Pharmaceutical Industry:Optimality Inside The Framework Of The Current Legal System Provides Access To Medicines For Hiv/Aids Patients In Sub-Saharan Africa, Gourav N. Mukherjee
Florida State University Journal of Transnational Law & Policy
No abstract provided.
The R.F.I.D. Act Of 2006 And E-Pedigrees: Tackling The Problem Of Counterfeit Drugs In The United States Wholesale Industry, Suchira Ghosh
The R.F.I.D. Act Of 2006 And E-Pedigrees: Tackling The Problem Of Counterfeit Drugs In The United States Wholesale Industry, Suchira Ghosh
Michigan Telecommunications & Technology Law Review
Gaps within the drug distribution system make it increasingly vulnerable to bad actors, such as counterfeiters and terrorists. Congress intended the Prescription Drug Marketing Act (PDMA) of 1987 to close these gaps, but the PDMA has not fully succeeded. Important PDMA provisions that require tracking of drugs throughout the distribution chain in the form of "pedigrees" were set to be implemented as of Dec. 1, 2006, although a recent court order has stayed complete implementation. However, these PDMA requirements do not apply uniformly to all drug distributors in the United States. Moreover, since paper pedigrees can be forged, the pedigree …
Pharmaceutical Lemons: Innovation And Regulation In The Drug Industry, Ariel Katz
Pharmaceutical Lemons: Innovation And Regulation In The Drug Industry, Ariel Katz
Michigan Telecommunications & Technology Law Review
Before a new drug can be marketed, the Food and Drug Administration must be satisfied that it is safe and effective. According to conventional wisdom, the cost and delay involved in this process diminish the incentives to invest in the development of new drugs. Accordingly, several reforms aimed at restoring such incentives have been implemented or advocated. This Article challenges the central argument that drug regulation and drug innovation are necessarily at odds with one another. Although intuitively appealing, the argument that drug regulation negatively affects the incentives to innovate does not fully capture the role that regulation plays in …
The Fda And The Future Of The Brain-Computer Interface: Adapting Fda Device Law To The Challenges Of Human-Machine Enhancement, 25 J. Marshall J. Computer & Info. L. 117 (2007), Eric Chan
UIC John Marshall Journal of Information Technology & Privacy Law
No abstract provided.
Legislative Updates, Dan Raposa
Fighting Baseball Doping In Latin America: A Critical Analysis Of Major League Baseball's Drug Prevention And Treatment Program In The Dominican Republic And Venezuela, David P. Fidler, Arturo J. Marcano Guevara
Fighting Baseball Doping In Latin America: A Critical Analysis Of Major League Baseball's Drug Prevention And Treatment Program In The Dominican Republic And Venezuela, David P. Fidler, Arturo J. Marcano Guevara
Articles by Maurer Faculty
No abstract provided.
Banning Smoking In Chicago's Social Scene: Protecting Labor And Broadening Public Health Policy, 40 J. Marshall L. Rev. 1063 (2007), Adrienne Detanico
Banning Smoking In Chicago's Social Scene: Protecting Labor And Broadening Public Health Policy, 40 J. Marshall L. Rev. 1063 (2007), Adrienne Detanico
UIC Law Review
No abstract provided.
The Fda Preamble: A Backdoor To Federalization Of Prescription Warning Labels?, 41 J. Marshall L. Rev. 161 (2007), Cristina Rodríguez
The Fda Preamble: A Backdoor To Federalization Of Prescription Warning Labels?, 41 J. Marshall L. Rev. 161 (2007), Cristina Rodríguez
UIC Law Review
No abstract provided.
Granholm V. Heald: The Twenty-First Amendment Takes Another Hit - Where Do States Go From Here?, 40 J. Marshall L. Rev. 651 (2007), William Glunz
Granholm V. Heald: The Twenty-First Amendment Takes Another Hit - Where Do States Go From Here?, 40 J. Marshall L. Rev. 651 (2007), William Glunz
UIC Law Review
No abstract provided.
Refusal To Dispense Emergency Contraception In Washington State: An Act Of Conscience Or Unlawful Sex Discrimination?, Dana E. Blackman
Refusal To Dispense Emergency Contraception In Washington State: An Act Of Conscience Or Unlawful Sex Discrimination?, Dana E. Blackman
Michigan Journal of Gender & Law
This Article will demonstrate that a pharmacist's refusal to fill a valid prescription for emergency contraception constitutes sex discrimination and violates the WLAD. Part I explains the nature and function of emergency contraceptive pills (ECPs) as well as their role in basic health care for women and the importance of their accessibility. Part II addresses federal civil rights protections and the failure of these protections to provide relief for women facing refusals. Focusing on the WLAD, Part II also explains how state public accommodation statutes protect women from discrimination in places of public accommodation. It further sets forth the prima …
Issues In The Interpretation Of 180-Day Exclusivity, Erika Lietzan, David E. Korn
Issues In The Interpretation Of 180-Day Exclusivity, Erika Lietzan, David E. Korn
Faculty Publications
Congress created 180-day exclusivity for generic drug applicants in the 1984 Hatch-Waxman amendments to the Federal Food, Drug, and Cosmetic Act (FDCA) and amended it substantially in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). The core concept of this exclusivity as it has been applied by FDA and the courts is that the first generic drug applicant to challenge an innovator's patent is entitled to six months of exclusivity against subsequent patent challengers for the same innovator drug. The 180-day exclusivity provision is governed by sections 505(j)(5)(B)(iv) and 505(j)(5)(D) of the FDCA, and it is intended …
Obesity, Public Health, And The Food Supply, Barbara L. Atwell
Obesity, Public Health, And The Food Supply, Barbara L. Atwell
Elisabeth Haub School of Law Faculty Publications
This Article proposes a three-part approach to improve the food supply. Specifically, it explores government taxing and spending, two traditional public health tools, and suggests that both of these governmental powers can be used to make healthier foods more readily reasonable prices, while increasing the cost of less healthy alternatives. Finally, it proposes that we promote a true “food democracy” through the creation of an education and awareness campaign. This campaign would not only better educate Americans about proper nutrition but would also focus on how we can change our entire relationship with food. It would encourage consumption of locally …
Diversifying Without Discriminating: Complying With The Mandates Of The Trips Agreement, Graeme B. Dinwoodie, Rochelle C. Dreyfuss
Diversifying Without Discriminating: Complying With The Mandates Of The Trips Agreement, Graeme B. Dinwoodie, Rochelle C. Dreyfuss
Michigan Telecommunications & Technology Law Review
Since the Patent Act was revised in 1952, patent law has expanded to cover an array of novel endeavors--new fields of technology (notably computer science and business methods) as well as the activities of researchers engaged in fundamental scientific discovery. These changes have been accompanied by shifts in the organizational structure of the technological community, with smaller firms and universities emerging as important players in the patent system, and by new marketplace expectations arising from consumer demand for interoperable technology and converging functionality. As a result of these developments, structural flaws in the legal order have become evident. Although the …
Restoring The Genetic Commons: A Common Sense Approach To Biotechnology Patents In The Wake Of Ksr V. Teleflex , Anna Bartow Laakmann
Restoring The Genetic Commons: A Common Sense Approach To Biotechnology Patents In The Wake Of Ksr V. Teleflex , Anna Bartow Laakmann
Michigan Telecommunications & Technology Law Review
In this Article, I argue that a new approach to biotechnology patenting is necessary to fully realize the tremendous potential of recent advances in our understanding of the human genome. Part I places the gene patenting debate in context by highlighting the key landmarks that have shaped the biotechnology industry and outlining the products and stakeholders that comprise the industry. Part II describes the current state of the law on biotechnology patents, summarizing the Federal Circuit's application of the various doctrines that collectively define the patent landscape's parameters. In this Part, I explain how the Federal Circuit's jurisprudence is tied …
The Patent End Game: Evaluating Generic Entry Into A Blockbuster Pharmaceutical Market In The Absence Of Fda Incentives, Jeremiah Helm
The Patent End Game: Evaluating Generic Entry Into A Blockbuster Pharmaceutical Market In The Absence Of Fda Incentives, Jeremiah Helm
Michigan Telecommunications & Technology Law Review
Generic drugs play an important role in the American system of health care. Most anticipate that the entry of these drugs into the market will lower prices and thereby increase treatment options for consumers. To stimulate generic entry, the Food and Drug Administration currently offers a period of marketing exclusivity to the first firm that gains approval for a generic version of a branded drug. During this 180-day period, only two firms can sell versions of the drug: the original, branded drug maker and the first approved generic firm. After the period of exclusivity expires, other generic firms are free …
Fda Approval Of Generic Biologics: Finding A Regulatory Pathway, Kathleen R. Kelleher
Fda Approval Of Generic Biologics: Finding A Regulatory Pathway, Kathleen R. Kelleher
Michigan Telecommunications & Technology Law Review
Biologics are becoming increasingly important for the potential treatment of widespread diseases such as cancer, anemia, and diabetes. As hundreds of biologics are going off-patent, the market has become ripe for the introduction of generic biologics. A regulatory pathway for biogenerics, however, is virtually nonexistent. The purpose of this paper is thus to analyze how a successful legislative pathway for generic biologics might be designed. The current regulatory scheme, economic concerns, health and safety concerns, and the need to provide proper incentives for innovation are analyzed. Finally, recent Congressional bills are outlined and critiqued, through which the structure of a …
The Use Of Drug Testing To Police Sex And Gender In The Olympic Games, Haley K. Olsen-Acre
The Use Of Drug Testing To Police Sex And Gender In The Olympic Games, Haley K. Olsen-Acre
Michigan Journal of Gender & Law
Part I of this Article discusses the history and development of sex testing and drug testing and argues that the two are both historically and ideologically linked. Part II examines the current Code in detail and argues that the Code's focus on hormone-based controls acts to police sex and gender in Olympic athletes, thereby extending historical sex testing practices to a new era. This Article ultimately concludes that without recognizing and addressing the need for further research into the role of "sex" hormones in the body and the interplay of social context and biological circumstances, the IOC cannot maintain an …
Tax And Economic Policy Responses To The Medicaid Long-Term Care Financing Crisis: A Behavioral Economics Approach, Diane Lourdes Dick
Tax And Economic Policy Responses To The Medicaid Long-Term Care Financing Crisis: A Behavioral Economics Approach, Diane Lourdes Dick
Cardozo Public Law, Policy & Ethics Journal
The article examines the escalating strain on Medicaid due to rising long-term care costs and an aging population, emphasizing the ineffectiveness of current policies promoting private insurance. It critiques traditional economic models for neglecting behavioral factors like emotional resistance to planning for aging and underestimating future care needs. The analysis concludes that voluntary measures, such as tax incentives and partnership programs, are insufficient and advocates for a universal compulsory program to ensure adequate preparation for long-term care, thereby reducing Medicaid reliance.
Winning The Battle, But Perhaps Losing The War: Endorsing Deregulation Of Emergency Contraception At The Expense Of Derogating Abortion, Melissa Bond
Cardozo Journal of International and Comparative Law
No abstract provided.
Enhancing Drug Effectiveness And Efficacy Through Personal Injury Litigation, Anita Bernstein
Enhancing Drug Effectiveness And Efficacy Through Personal Injury Litigation, Anita Bernstein
Faculty Scholarship
No abstract provided.
The First Amendment And Diet Industry Advertising: How Puffery In Weight-Loss Advertisements Has Gone Too Far, Jennifer E. Gross
The First Amendment And Diet Industry Advertising: How Puffery In Weight-Loss Advertisements Has Gone Too Far, Jennifer E. Gross
Journal of Law and Health
Stricter government regulations regarding commercial speech that promotes weight-loss or diet products should be considered for three reasons. First, studies have shown that diet industry advertising often makes weight loss claims that are scientifically impossible. Second, consumers have suffered adverse health effects as a result of trying weight-loss programs or diet products. Third, current FTC regulations are not curbing the problem. Part II of this note outlines the history of commercial speech and its protections under the First Amendment, along with the history of the rapidly expanding diet industry and its regulatory framework. Part II examines the three arguments in …
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, …
Restricting Access To Unapproved Drugs: A Compelling Government Interest , Peter M. Currie
Restricting Access To Unapproved Drugs: A Compelling Government Interest , Peter M. Currie
Journal of Law and Health
The prospective review and approval of drugs is central to the public health mission of the United States Food and Drug Administration (FDA). Requiring pharmaceutical manufacturers to generate information about their products' safety and efficacy enables the agency to evaluate the risks and benefits associated with their use, thereby preventing overly harmful products from reaching the market. The majority of consumers benefit from this intervention by gaining access to an array of drugs that are proven to be safe and effective. Thus, governmental regulation in this area is arguably justified because the aggregate social welfare is substantially improved. However, this …
Forced Medication And The Need To Protect The Rights Of The Mentally Ill Criminal Defendant, Emily C. Lieberman
Forced Medication And The Need To Protect The Rights Of The Mentally Ill Criminal Defendant, Emily C. Lieberman
Cardozo Public Law, Policy & Ethics Journal
The note argues that the current legal framework for forcibly medicating mentally ill criminal defendants, particularly pre-trial detainees, often violates their constitutional rights. It contends that the reliance on "dangerousness" as a criterion for forced medication is too vague and easily abused, leading to inconsistent and unconstitutional applications. The analysis advocates for stricter standards, clearer definitions of dangerousness, and heightened judicial scrutiny to protect the rights of mentally ill defendants.
What Does Accidental Mean?: Autoerotic Asphyxiation As An Illustration Of The Problems Affecting Accident Insurance, Gabriel Burnham
What Does Accidental Mean?: Autoerotic Asphyxiation As An Illustration Of The Problems Affecting Accident Insurance, Gabriel Burnham
Cardozo Journal of Equal Rights & Social Justice
The note argues that the legal system's inconsistent interpretation of what constitutes an "accident" in the context of accidental death insurance leads to confusion and inequitable outcomes, particularly in cases involving autoerotic asphyxiation. It advocates for federal regulation to standardize definitions and reduce discrepancies in court decisions.
Secondhand Smoke Signals From Prison, Scott C. Wilcox
Secondhand Smoke Signals From Prison, Scott C. Wilcox
Michigan Law Review
This Note argues that courts should acknowledge current societal and medical perspectives on second hand smoke (SHS) and afford real protection to prisoners against SHS through injunctive relief. Part I examines evidence that conclusively demonstrates the serious risk of harm posed by SHS to the health of inmates. It reports that inmates' long-term exposure to SHS increases their risk of contracting lung cancer, heart disease, and other potentially life threatening conditions. Part II argues that, as required by the Helling standard, contemporary society does not tolerate involuntary, long-term exposure to SHS and that prison officials exhibit deliberate indifference by allowing …
Reviving Lazarus: Status Of The Fda Compliance Defense After Bates V. Dow Agrosciences And The New Fda Regulations, Jason T. Ams
Reviving Lazarus: Status Of The Fda Compliance Defense After Bates V. Dow Agrosciences And The New Fda Regulations, Jason T. Ams
Kentucky Law Journal
No abstract provided.
To Achieve Closure Of The Hatch-Waxman Act's Loopholes, Legislative Action Is Unnecessary; Generic Manufacturers Are Able To Hold Their Own, Yana Pechersky
To Achieve Closure Of The Hatch-Waxman Act's Loopholes, Legislative Action Is Unnecessary; Generic Manufacturers Are Able To Hold Their Own, Yana Pechersky
Cardozo Arts & Entertainment Law Journal
No abstract provided.
Outsourcing Drug Investigations To India: A Comment On U.S., Indian, And International Regulation Of Clinical Trials In Cross-Border Pharmaceutical Research, James Cekola
Northwestern Journal of International Law & Business
The traditional research and development model of large pharmaceutical companies is arguably unsustainable in current times. For example, estimated research and development costs increased as much as twelve percent over the last year while pharmaceutical sales grew only seven percent over the same period. Current estimates put the price to develop a new drug and bring it to market between $800 million and $1.5 billion per drug. These costs are increasing, driving large pharmaceutical companies to find more cost-effective research and development models. One cost-saving initiative is to globalize the system. In particular, companies have increasingly outsourced the required investigational …