Volume 61 Issue 2
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Table of Contents
> The International Regulation of Genetically Modified Organisms: Importing Caution Into the U.S. Food Supplyby Debra M. Strauss, Assistant Professor of Business Law, Fairfield University, Charles F. Dolan School of Business, Fairfield, Conn. She received her B.A. from Cornell University and her J.D. from Yale Law School. Professor Strauss, a former Food and Drug Law Institute Scholar, currently teaches international business law.
> Health and Food Safety: The Benefits of Bt-Corn
by Drew L. Kershen, Earl Sneed Centennial Professor of Law, University of Oklahoma College of Law, Norman, Okla.
> Old Customs, Ancient Lore: The Development of Custom Device Law Through Neglect
by Robert J. Kleplinski, an officer of Fredrikson & Byron, P.A., in Minneapolis, MN. He was formerly the regulatory attorney for Medtronic, Inc.
> The Food and Drug Administration's Regulation of Risk Disclosure for Implantable Cardioverter Defibrillators: Has Technology Outpaced the Agency's Regulatory Framework?
by Edward M. Basile, Senior Partner with King & Spalding LLP in Washington, D.C., and has over twenty-five years of experience interpreting the laws and regulations of the Food and Drug Administration.
and
Beverly H. Lorell, M.D., FACC, most recently Vice President and Chief Medical and Technology Officer at Guidant Corporation, Indianapolis, Indiana and is a former Professor of Medicine at Harvard Medical School.
> Merck v. Integra: Supreme Court Permits Use of Patented Compounds to Obtain Food and Drug Administration Approvals
by John R. Manthei, Partner in the law firm of Latham & Watkins LLP, Washington, D.C.
and
Carolyne R. Hathaway, Partner in the law firm of Latham & Watkins LLP, Washington, D.C.
and
Maximilian A. Grant, Associate in the law firm of Latham & Watkins LLP, Washington, D.C.
and
Dutch D. Chung, Ph.D., Associate in the law firm of Latham & Watkins LLP, Washington, D.C.
> Your Business in Court - 2005
by John B. Reiss, Ph.D., J.D., Partner in the Business Department & is Chair of the Health Law Practice Group, Saul Ewing LLP, Philadelphia, PA.
and
Mark C. Levy, Partner in the Litigation Department, Saul Ewing LLP, Philadelphia, PA.
and
Allison B. Newhart, Associate in the Litigation Department, Saul Ewing LLP, Philadelphia, PA.
> The Food and Drug Administration's Use of Postmarketing (Phase IV) Study Requirements:
Exception to the Rule?
by Charles Steenburg, currently an associate at Wolf, Greenfield & Sacks, P.C. Opinions expressed herein are those of the author alone. An earlier version of this article won Second Place in the 2005 H. Thomas Austern Memorial Writing Competition (long papers) sponsored by the Food and Drug Law Institute. The author would like to thank Mr. Peter Barton Hutt and Ms. Virgina Wise for their guidance during the preparation of this article and Dr. Bruce Patsner for his helpful comments during the revision process.
> Not As Easy As It May Appear: Using Radio Frequency Identification Technology to Fulfill the Prescription Drug Marketing Act's Elusive Pedigree Requirement
by Afia K. Asamoah, currently is a law clerk for the Hon. Harold Baer, Jr. Southern District of New York. Opinions expressed herein are those of the author alone. An earlier version of this article won Honorable Mention in the 2005 H. Thomas Austern Memorial Writing Competition (long papers) sponsored by the Food and Drug Law Institute. The author would like to thank Jeffrey Francer for his helpful comments during the revision process.
The International Regulation of Genetically Modified Organisms:
Importing Caution Into the U.S. Food Supply
Author: Debra M. Strauss
61 FOOD AND DRUG LAW JOURNAL 167-196 (2006).
Biotechnology in the food industry has developed rapidly in recent years. In the United States, genetically modified organisms in food have increased exponentially, while these products are largely banned and strictly regulated overseas. After examining the scientific issues, including unintended risks to human health and the environment, this article explores the rigorous regulatory scheme of the European Union and international community in contrast to the relatively unrestrictive approach of the United States. The article proposes an expanded model of mandatory positive labeling, in combination with voluntary negative labeling, along with a system of pre- and postmarket testing, monitoring, and tracking of genetically modifird components. In responding to the concerns of its citizens and giving greater weight to unknown risks, the U.S. government would increase consumer confidence and strengthen the long-term viability of the biotechnology industry. Moreover, by implementing more stringent standards, the United States can regain entry for its agricultural products into the global marketplace
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Health and Food Safety: The Benefits of Bt-Corn
Author: Drew L. Kershen
61 FOOD AND DRUG LAW JOURNAL 197-235 (2006).
In 1990-1991, Mexican-American women in the Rio Grande valley experienced pregnancies affected by neural tube defects (NTDs) at a surprisingly high rate. Investigators learned that NTD pregnancies are endemic to the region. Mexican-American women on the Rio Grande border are poor women who consume a diet heavy in corn tortillas. The corn is contaminated with a mycotoxin called fumonisin. Similar patterns of NTD-afflicted pregnancies have been found in China, Guatemala, and South Africa.
Bt-corn is a transgenic crop that is resistant to certain insects. Bt-corn has significantly reduced fumonisin contamination because it better controls these insects. This article argues that women would benefit if their corn diets came from Bt-corn varieties and that consumers and animals also would experience better, improved health through the widespread adoption of Bt-corn. The scientific basis for health benefits from Bt-corn is explained and the legal issues relating to food safety statutes and regulations, products liability, and product warranty arising from the fact that Bt-corn has health and food safety benefits are addressed.
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Old Customs, Ancient Lore: The Development of Custom Device Law Through Neglect
Author: Robert J. Klepinski
61 FOOD AND DRUG LAW JOURNAL 237-250 (2006).
The custom device exemption (section 520(b)) of the Federal Food, Drug, and Cosmetic Act was established by Congress to provide for specific needs of patients and healthcare professionals. The exemption can provide an efficient mechanism for providing patient care in cases where there is no marketed product to fill the need. Although custom devices have been provided to many physicians, the U.S. Food and Drug Administration (FDA) has never issued a regulation or guidance specifically covering custom devices. Many unanswered questions exist, therefore, such as what actually qualifies as a custom device, how many can be made, etc. This article addresses various scenarios and guidance issues that have arisen because of the variety of types of custom devices. While it is unlikely that FDA could establish a clear “safe harbor,” indicating the maximum number of custom devices one could manufacture, some explicit, written guidance can be created by the agency, based on prior experience and the statutory intent.
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The Food and Drug Administration's Regulation of Risk Disclosure for Implantable Cardioverter Defibrillators: Has Technology Outpaced the Agency's Regulatory Framework?
Authors: Edward M. Basile & Beverly H. Lorell
61 FOOD AND DRUG LAW JOURNAL 251-272 (2006).
Recent advances in medical technology have led to great strides in patient care, life improvement, and preservation; however, these advances have outpaced the present regulatory framework, leading to many challenges and controversies for postmarket device safety surveillance and communication. This article explores some of these challenges, focusing specifically on implantable cardiovascular devices with an emphasis on Food and Drug Administration (FDA)-industry processes and the changing expectations for transparency and safety. This overview reflects the perspectives of a cardiologist who has cared for heart failure patients for two decades and who served as a medical officer in the device industry, and an attorney with extensive experience interpreting FDA’s medical device laws and regulations.
The article briefly reviews the clinical impact of cardiac rhythm management devices and the legal provisions related to postmarket surveillance in the United States. In addition, the limitations of the current structure and terminology are described and improvements that would better accommodate these complex devices are suggested. Finally, the authors present their perspectives on the “elephants in the room,” the key unaddressed issues that must be confronted in order to improve the industry-FDA processes of postmarket safety surveillance.
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Merck v. Integra: Supreme Court Permits Use of Patented Compounds to Obtain Food and Drug Administration Approvals
Authors: John R. Manthei, Carolyne R. Hathaway, Maximilian A. Grant & Dutch D. Chung
61 FOOD AND DRUG LAW JOURNAL 273-278 (2006).
This article discusses the impact of the U.S. Supreme Court's recent decision in Merck KGaA v. Integra Life Sciences I, Ltd. on the pharmaceutical industry. Before passage of the Hatch-Waxman Act, only a patent holder and its licensees could make or use a patented compound to conduct drug research to develop other useful drugs. The Supreme Court decided in Merck v. Integra that a company may use another company's patented inventions to conduct testing in advance of the patent's expiration provided that it is "reasonably related to the development and submission of any information" required under the Federal Food, Drug, and Cosmetic Act. The Supreme Court broadly interpreted the safe harbor provided by the Patent Code to permit the use of a patented compound in preclinical and clinical studies of a drug candidate's safety, pharmacologic effects, and mechanism of action, so long as certain criteria are met. Merck v. Integra brings welcome relief to pharmaceutical companies seeking to develop new drugs derived from a patented compound held by another company.
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Your Business in Court - 2005
Authors: John B. Reiss, Mark C. Levy & Allison B. Newhart
61 FOOD AND DRUG LAW JOURNAL 279-294 (2006).
This article examines various legal issues facing the medical device, biotechnology and pharmaceutical industries through a discussion of regulatory actions taken by agencies, and court decisions or settlements occurring, in the year 2005 that impacted these industries. The article suggests future activities industry should consider undertaking as a result of these actions, decisions, and settlements. The article looks at fraud and abuse issues and the False Claims Act; enforcement activities undertaken by the Securities and Exchange and Federal Trade Commissions; the impact cases brought by states, local governments, and consumers have had on pharmaceutical product pricing; the Class Action Fairness Act and efforts by the Food and Drug Administration (FDA) to preempt state tort claims—highlights of a number of events favorable to industry. Cases addressing the learned intermediary doctrine in the context of post-sale duty to warn cases and those where FDA has sought restitution from those prescription drug manufacturers violating the Federal Food, Drug, and Cosmetic Act are reviewed. The article concludes that many of these issues can be best addressed by having integrated compliance plans in place that result in comprehensive oversight of a company’s activities in FDA’s, SEC’s and FTC’s regulatory spheres, in payor coverage, payment, and pricing strategies, and in marketing programs and postmarketing surveillance.
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The Food and Drug Administration's Use of Postmarketing (Phase IV) Study Requirements:
Exception to the Rule?
Author: Charles Steenburg
61 FOOD AND DRUG LAW JOURNAL 295-384 (2006).
Postmarketing (Phase IV) studies have evolved over the course of thirty-five years from a rare exception to a comparatively routine part of how the Food and Drug Administration and drug sponsors navigate the drug approval process. This article analyzes the exogenous influences and internal agency dynamics that together have spurred this dramatic growth. The article also considers the tenuous statutory foundation supporting the bulk of Phase IV study requirements—often nominally “requests.” The article considers some of the problems that have arisen as postmarketing commitments have become more common and concludes by proposing a scheme for curtailing this trend while ensuring that drug sponsors do in fact complete critical studies.
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Not As Easy As It May Appear: Using Radio Frequency Identification Technology to Fulfill the Prescription Drug Marketing Act's Elusive Pedigree Requirement
Author: Afia K. Asamoah
61 FOOD AND DRUG LAW JOURNAL 385-418 (2006).
In the most recent stay of the final rule implementing the pedigree requirement of the Prescription Drug Marketing Act (PDMA) of 1987, the Food and Drug Administration (FDA) recommended that the drug wholesaler industry voluntarily adopt radio frequency identification technology (RFID) to fulfill the pedigree requirement of the act. In so doing, FDA expressed a desire to exert minimal regulatory oversight over the implementation of this technology. This article reviews the potential regulatory and policy implications of using RFID technology to satisfy the PDMA’s pedigree requirement and explores whether it is likely that the electronic pedigree generated using RFID technology will be the talisman that will address the concerns of industry while fulfilling the purposes of the PDMA.
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