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2009

Food and Drug Law

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Articles 1 - 30 of 64

Full-Text Articles in Law

Cloned Meat, Voluntary Food Labeling, And Organic Oreos, Donna M. Byrne Dec 2009

Cloned Meat, Voluntary Food Labeling, And Organic Oreos, Donna M. Byrne

The University of New Hampshire Law Review

[Excerpt] “In December 2006, the Food and Drug Administration (FDA) announced that it had reviewed all the available evidence and was poised to approve meat and milk from cloned animals and their progeny. I remember telling one of my colleagues, a patent law professor, who should be as comfortable with technology as anyone, about this development, and his response was, “Yuck. I’m not eating it!” To which of course I replied, “Humph. You won’t know the difference.” Meat or milk from a clone or its descendant is virtually identical to meat or milk from a non-clone, said the ...


An Information Prescription For Prescription Drug Regulation, Anita Bernstein, Joseph Bernstein Dec 2009

An Information Prescription For Prescription Drug Regulation, Anita Bernstein, Joseph Bernstein

Faculty Scholarship

No abstract provided.


Regulatory Dysfunction: How Insufficient Resources, Outdated Laws, And Political Interference Cripple The 'Protector Agencies', Sidney A. Shapiro, Rena I. Steinzor, Matthew Shudtz Nov 2009

Regulatory Dysfunction: How Insufficient Resources, Outdated Laws, And Political Interference Cripple The 'Protector Agencies', Sidney A. Shapiro, Rena I. Steinzor, Matthew Shudtz

Rena I. Steinzor

In the last several years, dramatic failures of the nation’s food safety system have sickened or killed tens of thousands of Americans, and caused billions of dollars of damages for producers and distributors of everything from fresh vegetables to granola bars and hamburger meat. In each case, the outbreak of food-borne illness triggered what can only be described as a frantic scramble by health officials to discover its source. Inevitably, the wrong lead is followed or a recall is too late or too narrow to prevent further illnesses, and the government has to defend itself against withering criticism. Americans ...


Contemporary Water Issues, Susan Kelly Nov 2009

Contemporary Water Issues, Susan Kelly

Publications

No abstract provided.


Punishing Pharmaceutical Companies For Unlawful Promotion Of Approved Drugs: Why The False Claims Act Is The Wrong Rx, Vicki W. Girard Oct 2009

Punishing Pharmaceutical Companies For Unlawful Promotion Of Approved Drugs: Why The False Claims Act Is The Wrong Rx, Vicki W. Girard

Georgetown Law Faculty Publications and Other Works

This article criticizes the shift in focus from correction and compliance to punishment of pharmaceutical companies allegedly violating the Food, Drug, & Cosmetic Act (FD&C Act) prohibitions on unlawful drug promotion. Traditionally, the Food and Drug Administration (FDA) has addressed unlawful promotional activities under the misbranding and new drug provisions of the FD&C Act. Recently though, the Justice Department (DOJ) has expanded the purview of the False Claims Act to include the same allegedly unlawful behavior on the theory that unlawful promotion “induces” physicians to prescribe drugs that result in the filing of false claims for reimbursement. Unchecked and ...


Land & Water Planning: Another State's Perspective - Water Resources Regional Plan Policies, Kathleen M. Chavez, P.E. Oct 2009

Land & Water Planning: Another State's Perspective - Water Resources Regional Plan Policies, Kathleen M. Chavez, P.E.

Publications

No abstract provided.


Unsettling Drug Patent Settlements: A Framework For Presumptive Illegality, Michael A. Carrier Oct 2009

Unsettling Drug Patent Settlements: A Framework For Presumptive Illegality, Michael A. Carrier

Michigan Law Review

A tidal wave of high drug prices has recently crashed across the U.S. economy. One of the primary culprits has been the increase in agreements by which brand-name drug manufacturers and generic firms have settled patent litigation. The framework for such agreements has been the Hatch-Waxman Act, which Congress enacted in 1984. One of the Act's goals was to provide incentives for generics to challenge brand-name patents. But brand firms have recently paid generics millions of dollars to drop their lawsuits and refrain from entering the market. These reverse-payment settlements threaten significant harm. Courts nonetheless have recently blessed ...


The Dialogue Between Biomedicine And Law In An “Intraamerican Transnational Perspective”, Charles H. Baron Jul 2009

The Dialogue Between Biomedicine And Law In An “Intraamerican Transnational Perspective”, Charles H. Baron

Boston College Law School Lectures and Presentations

No abstract provided.


Constitutional Flaw?, Carl E. Schneider Jul 2009

Constitutional Flaw?, Carl E. Schneider

Articles

Do terminally ill patients have a constitutional right "to decide, without FDA interference, whether to assume the risks of using potentially life-saving investigational drugs that the FDA has yet to approve for commercial marketing, but that the FDA has determined, after Phase I clinical human trials, are safe enough for further testing"? In Abigail Alliance for Better Access to Developmental Drugs v. McClellan, the United States District Court for the District of Columbia said "no." In Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, a panel (three judges) of the United States Court of Appeals for the ...


Wyeth V. Levine And Its Implications, Brian Wolfman May 2009

Wyeth V. Levine And Its Implications, Brian Wolfman

Georgetown Law Faculty Publications and Other Works

The U.S. Supreme Court’s decision in Wyeth v. Levine sharply limited the availability of implied preemption as a defense in pharmaceutical cases. In this Analysis & Perspective, attorney Brian Wolfman discusses the decision and its implications for prescription drug litigation as well as litigation in other areas that are regulated by the federal government.

After Wyeth, Wolfman says, a defendant in a prescription drug case must demonstrate a ‘‘tight fit between the labeling change proposed by the manufacturer (and rejected by the FDA) and the labeling change that the plaintiff contends would have prevented her injuries.’’ Moreover, he says ...


Steps To Flow Restoration: Lessons From The Northwest, Reed D. Benson May 2009

Steps To Flow Restoration: Lessons From The Northwest, Reed D. Benson

Publications

No abstract provided.


Ecological Flows In New Mexico - It Has Been Done, Adrian Oglesby May 2009

Ecological Flows In New Mexico - It Has Been Done, Adrian Oglesby

Publications

No abstract provided.


The Pragmatics Of Allocating Water For Stream Flows, Steve Harris May 2009

The Pragmatics Of Allocating Water For Stream Flows, Steve Harris

Publications

No abstract provided.


New Mexico Wildlife Conservation Act: Cooperative Action For Native Species Recovery, Stephanie Carman, David Propst May 2009

New Mexico Wildlife Conservation Act: Cooperative Action For Native Species Recovery, Stephanie Carman, David Propst

Publications

No abstract provided.


Pharmaceutical Drug Testing In The Former Soviet Union: Contract Research Organizations As Broker-Dealers In An Emerging Testing Ground For America's Big Pharma, Yevgenia Shtilman Apr 2009

Pharmaceutical Drug Testing In The Former Soviet Union: Contract Research Organizations As Broker-Dealers In An Emerging Testing Ground For America's Big Pharma, Yevgenia Shtilman

Boston College Third World Law Journal

Developing countries are a fertile testing ground for the research and development of new drug products. Recently, Western pharmaceutical companies expanded their overseas drug testing from India and Africa to the former Soviet Union, where doctors in need of reliable income conduct clinical trials on subjects seeking access to medical care. Although U.S. government agencies monitor clinical drug trials sponsored by American pharmaceutical companies, the scope of governmental authority is effectively limited to the companies’ domestic activities. In October 2008, restrictions on the FDA’s supervisory powers were further reinforced by the agency’s substitution of the ethical research ...


Revisiting The Regulation Debate: The Effect Of Food Marketing On Childhood Obesity, Nicole E. Hunter Apr 2009

Revisiting The Regulation Debate: The Effect Of Food Marketing On Childhood Obesity, Nicole E. Hunter

The University of New Hampshire Law Review

[Excerpt] “Despite the widespread concern regarding childhood obesity, there is broad divergence of opinion regarding responsibility for the crisis. Whether the government, food industry, or parents are accountable has become the focus of much debate. Public health groups have attempted various strategies to confront childhood obesity, such as litigation, legislation, and government regulation. While many researchers and advocates agree that government should play an affirmative role with respect to childhood obesity, they are very much divided over what that role should be. For example, although none of these acts has become law, eighty-six bills have been proposed regarding obesity since ...


An Opiate Of The Masses: Religious Gerrymandering Of Sacramental Intoxication, Mark A. Levine Apr 2009

An Opiate Of The Masses: Religious Gerrymandering Of Sacramental Intoxication, Mark A. Levine

North Carolina Central Law Review

No abstract provided.


Pharmaceutical Data Protection Law And Policy And Their Effects On The Right To Medicines : A Comparative Analysis, Yun-Ching Yeh Mar 2009

Pharmaceutical Data Protection Law And Policy And Their Effects On The Right To Medicines : A Comparative Analysis, Yun-Ching Yeh

Theses and Dissertations

To examine the compatibility between data protection and the right to access medicines in the current data protection regimes, this study examines the concept of data protection in current legal regimes, examine exclusive data protection regime, discusses the impact of the right to medicines on data protection regime, finally provide sound legal reform and recommendations to improve the protection of pharmaceutical data. In its entirety, this research aims at researching the protection regime of pharmaceutical data from top to bottom; therefore, this research conducts a comprehensive analysis within three dimensions of protections: first, the international dimension represented by TRIPS, second ...


Up In Smoke: Federal Preemption And Medicinal Marijuana Id Cards In County Of San Diego V. San Diego Norml, Douglas Farr Mar 2009

Up In Smoke: Federal Preemption And Medicinal Marijuana Id Cards In County Of San Diego V. San Diego Norml, Douglas Farr

Brigham Young University Journal of Public Law

No abstract provided.


Responding, Rather Than Reacting To, Race In Biomedical Research: A Response To Professors Caulfield And Mwaria, Michael J. Malinowski Feb 2009

Responding, Rather Than Reacting To, Race In Biomedical Research: A Response To Professors Caulfield And Mwaria, Michael J. Malinowski

Michael J. Malinowski

This Commentary is part of a colloquy on race-based genetics research.


Three Separate And Distinct Spheres: Patents, Regulation And Liability, Drew Kershen Jan 2009

Three Separate And Distinct Spheres: Patents, Regulation And Liability, Drew Kershen

Drew L. Kershen

No abstract provided.


Taking Aim At The Virginia Triggerman Rule: A Commentary On House Bill 2358, Anisa Mohanty Jan 2009

Taking Aim At The Virginia Triggerman Rule: A Commentary On House Bill 2358, Anisa Mohanty

Anisa Mohanty

No abstract provided.


International Harmonization Of Regulation Of Nanomedicine, Gary E. Marchant, Douglas J. Sylvester, Kenneth W. Abbott, Tara Lynn Danforth Jan 2009

International Harmonization Of Regulation Of Nanomedicine, Gary E. Marchant, Douglas J. Sylvester, Kenneth W. Abbott, Tara Lynn Danforth

Gary E. Marchant

Nanomedicine holds enormous promise for the improved prevention, detection and treatment of disease. Yet, at the same time, countervailing concerns about the potential safety risks of nanotechnologies generally, and nanomedical products specifically, threaten to derail or at least delay the introduction and commercial viability of many nanomedicine applications. All around the globe, national governments are struggling with balancing these competing benefits and risks of nanotechnology in the medical and other sectors. It is becoming increasingly clear that reasonable, effective and predictable regulatory structures will be critical to the successful implementation of nanotechnology. The question examined in this paper is whether ...


International Harmonization Of Regulation Of Nanomedicine, Gary E. Marchant, Douglas J. Sylvester, Kenneth W. Abbott, Tara Lynn Danforth Jan 2009

International Harmonization Of Regulation Of Nanomedicine, Gary E. Marchant, Douglas J. Sylvester, Kenneth W. Abbott, Tara Lynn Danforth

Gary E. Marchant

Nanomedicine holds enormous promise for the improved prevention, detection and treatment of disease. Yet, at the same time, countervailing concerns about the potential safety risks of nanotechnologies generally, and nanomedical products specifically, threaten to derail or at least delay the introduction and commercial viability of many nanomedicine applications. All around the globe, national governments are struggling with balancing these competing benefits and risks of nanotechnology in the medical and other sectors. It is becoming increasingly clear that reasonable, effective and predictable regulatory structures will be critical to the successful implementation of nanotechnology. The question examined in this paper is whether ...


Unnecessary Deaths Nad Unnecessary Costs: Getting Patented Drugs To Patients Most In Need, Erin M. Anderson Jan 2009

Unnecessary Deaths Nad Unnecessary Costs: Getting Patented Drugs To Patients Most In Need, Erin M. Anderson

Boston College Third World Law Journal

Medical epidemics that are constrained in the developed world are wrecking havoc on developing countries, which are bearing the brunt of HIV/AIDS, malaria, tuberculosis, and other infectious diseases. Because medicines used to treat these conditions are patented, they are expensive and inaccessible to poor countries. In 1994, the United Nations established a system of international patent protection through the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), and simultaneously tried to accommodate its commitment to making life-saving pharmaceuticals available to developing countries. When TRIPS failed to accomplish this goal, Article 31bis, an amendment to ...


Why Fdca Section 505(U) Should Not Concern Us Greatly, Kyle Faget Jan 2009

Why Fdca Section 505(U) Should Not Concern Us Greatly, Kyle Faget

Michigan Telecommunications & Technology Law Review

Among the many amendments found in the Food and Drug Administration Amendment Act of 2007 (FDAAA) is a provision at the end of the act, Section 505(u), which grants chiral switches five years of market exclusivity under certain circumstances. Prior to Congressional enactment of the FDAAA, the Food and Drug Administration (FDA) refused to award new chemical entity (NCE) status to enantiomers of previously approved racemic mixtures. The FDA defines a new chemical entity ("NCE") as a drug that contains no active moiety that has been approved by the FDA in any other application submitted under Section 505(b ...


Platitudes About Product Stewardship In Torts: Continuing Drug Research And Education, Lars Noah Jan 2009

Platitudes About Product Stewardship In Torts: Continuing Drug Research And Education, Lars Noah

Michigan Telecommunications & Technology Law Review

This Article focuses on one emerging aspect of tort litigation against pharmaceutical manufacturers that, if it gained traction, portends a dramatic (and potentially counterproductive) expansion in the prescription drug industry's exposure to liability. The traditional theories of products liability--mismanufacture, defective design, and inadequate warnings--no longer exhaust the potential obligations of sellers. In addition to increasingly popular claims of misrepresentation and negligent marketing, which seem more like extensions of the three defect categories than entirely novel theories, a growing chorus of commentators would impose on pharmaceutical manufacturers a broader duty to test and educate (aspects of what they call an ...


The Chinese Regulatory Licensing Regime For Pharmaceutical Products: A Law And Economics Analysis, Qing Zhang Jan 2009

The Chinese Regulatory Licensing Regime For Pharmaceutical Products: A Law And Economics Analysis, Qing Zhang

Michigan Telecommunications & Technology Law Review

China's pharmaceutical market has expanded dramatically in the past twenty years and is expected to become the largest in the world by the year 2050. However, entry to the market remains difficult for many international pharmaceutical manufacturers due to the country's costly and complicated regulatory licensing requirements. This Article provides an overview of the regulatory licensing regime for pharmaceutical products in China. Then, the Article evaluates three key features of the regulatory licensing regime through a law and economics approach. These features include the use of licensing, as contrasted with alternative regulatory and non-regulatory mechanisms; the standards to ...


Pdufa And Initial U.S. Drug Launches, Mary K. Olson Jan 2009

Pdufa And Initial U.S. Drug Launches, Mary K. Olson

Michigan Telecommunications & Technology Law Review

In the 1970s and 1980s, many pharmaceutical firms launched new drugs abroad prior to gaining U.S. approval. Consequently, U.S. patients often faced delays in accessing important new medicines. High regulatory barriers to entry, such as a stringent regulation and a lengthy drug review process, contributed to this problem. This Article examines the impact of the Prescription Drug User Fee Act (PDUFA), and subsequent increases in the speed of FDA review, on the likelihood of initial U.S. drug launches. These factors are hypothesized to lower regulatory barriers to entry in the U.S. pharmaceutical market. The results show ...


When And How To Defer To The Fda: Learning From Michigan's Regulatory Compliance Defense, Jason C. Miller Jan 2009

When And How To Defer To The Fda: Learning From Michigan's Regulatory Compliance Defense, Jason C. Miller

Michigan Telecommunications & Technology Law Review

Michigan's regulatory compliance defense properly recognizes that an FDA-approved drug carrying an FDA-approved label should not be considered defective. However, the statute's absolute immunity provides no compensation for injured parties in any circumstance, including situations where the FDA process has failed. Nevertheless, it is possible to treat the FDA's approval as significant without eliminating the possibility of all state actions against drug makers by providing a litigation back-up through state attorneys general ("AGs"). This Note examines the question of FDA approval in state tort actions in Part I, discusses Michigan's answer to that question in Part ...