Volume 58 Issue 4
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Table of Contents
> Bovine Spongiform Encephalopathy:
The Importance of Precautionary Measures to Protect the Food Supply
by Caroline Smith DeWaal, Director of Food Safety at the Center for Science in the Public Interest (CSPI), Washington, D.C.
> Reforming European Community Food Law: Putting Quality Back on the Agenda
by Caoimhín MacMaoláin, Lecturer in Law, University of Exeter, United Kingdom.
> The Hang-Up With HACCP:
The Resistance to Translating Science Into Food Safety Law
by Neal D. Fortin, Attorney in the Law Office of Neal D. Fortin, practicing food, regulatory, and administrative law. From 1997 to 2002, he was a manager of the food service regulatory program of the Michigan Department of Agriculture.
> The Food and Drug Administration's Import Alerts Appear to Be "Misbranded"
by Christine M. Humphrey, expects to graduate from the University of Miami School of Law, Miami, FL, in December 2003, and has accepted a position with Rodriguez O'Donnell Ross Fuerst Gonzalez & Williams P.C., Miami, FL. Since 1994, she has served as an Investigator and Compliance Officer for the Food and Drug Administration (FDA).
> Potential Legal Barriers to Increasing CMS/FDA Collaboration:
The Law of Trade Secrets and Related Considerations
by Stanley S. Wang, Resident Physician, Department of Internal Medicine, Duke University Medical Center, Durham, NC.
John J. Smith, Associate Radiologist, Massachusetts General Hospital; Associate Professor of Radiology, Harvard Medical School; and Director of Regulatory Affairs,Center for Integration of Medicine and Innovative Technology, Boston, MA.
> Prescription Drug Advertising—Should States Regulate What Is False and Misleading?
by John Shaeffer, Partner in the law firm of O'Donnell and Shaeffer, LLP, Los Angeles, CA.
> The Final Sampling Regulations of the Prescription Drug Marketing Act Are Alive and Well: Is Your Sampling Program Compliant?
by Jennifer A. Romanski, Associate with the law firm of Porzio, Bromberg & Newman, PC, Morristown, NJ.
> Therapeutic Orphans, Pediatric Victims? The Best Pharmaceuticals for Children Act and Existing Pediatric Human Subject Protection
by I. Glenn Cohen, Law Clerk to Chief Judge Michael Boudin, U.S. Court of Appeals for the First Circuit.
> Compulsory Licensing to Regulated Licensing: Effects on the Conflict Between Innovation and Access in the Pharmaceutical Industry
by Adi Gillat, Associate with the law firm of Heller Ehrman White & McAuliffe, in Washington, D.C.
> Commentary: Can We Talk? About Food and Drug Regulation and the First Amendment
by Marsha N. Cohen, Professor of Law at Hastings College of the Law (University of California). She served two terms as a member of the California State Board of Pharmacy.
Bovine Spongiform Encephalopathy:
The Importance of Precautionary Measures to Protect the Food Supply
Authors: Caroline Smith DeWaal & Leora Vegosen
Issue: 58 Food and Drug Law Journal 537-548 (2003).
Recent discoveries of cases of bovine spongiform encephalopathy (BSE) in Canada and the United States highlight the importance of protecting the U.S. food supply. This article analyzes BSE regulations and policies that are currently in place in the United States and discusses the need for further precautionary measures. Surveillance of imported products should be improved, the feed ban should be strengthened, and cattle spinal cord and other specified risk materials should be kept out of the human food supply. Government agencies should apply precaution to ensure that human food is protected before more cases of BSE are discovered.
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Reforming European Community Food Law: Putting Quality Back on the Agenda
Author: Caoimhín MacMaoláin
Issue: 58 Food and Drug Law Journal 549-564 (2003).
The Commission, the Council, and the European Court of Justice have all faced criticism over European Community food laws. Consequently, several important legislative reforms have taken place in recent years, designed to facilitate further the free movement of goods and to ensure that consumers receive the maximum level of protection. This article examines two such reforms relating to the quality of foodstuffs—the replacement of the "recipe laws" and the protection of geographical food names—and suggests a third, the introduction of a European social label. The article tests these reforms individually and identifies an important remaining difficulty: the substance of the new legislation, and the manner in which the Court deals with it, generally tends to bias free movement at the expense of quality maintenance. The article concludes by examining, in more general terms, how the harmonization of food law should be achieved.
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The Hang-Up With HACCP:
The Resistance to Translating Science Into Food Safety Law
Author: Neal D. Fortin
Issue: 58 Food and Drug Law Journal 565-594 (2003).
Foodborne illness strikes millions every year, and thousands die. HACCP, short for Hazard Analysis and Critical Control Point, could prevent much of that illness; however, it remains underutilized. HACCP's slow adoption correlates with imperfect information on the safety of food both before and after purchase. Consequently, the market is inefficient at rewarding firms that implement improved food safety measures, and it rewards firms that externalize certain food safety risks. This market inefficiency creates an underproduction of the level of food safety that consumers desire. The author proposes applying an understanding of this market inefficiency to construct a food safety system that adjusts for the current imbalance.
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The Food and Drug Administration's Import Alerts Appear to Be "Misbranded"
Author: Christine M. Humphrey
Issue: 58 Food and Drug Law Journal 595-612 (2003).
The Food and Drug Administration's (FDA's) responsibility for protecting U.S. consumers from imported products that pose potential harm to the health and welfare of American citizens is an incredible challenge in today's environment. The agency uses Import Alerts as a vehicle to ensure uniform import coverage and provide the highest level of protection to consumers in the United States. For FDA to achieve this goal, however, the agency must reassess the way it labels and issues Alerts. FDA misbrands Alerts by labeling them as "guidance." The effect on the importing community is a lack of procedural fairness that significantly affects the ability of a U.S. importer and foreign manufacturer to import FDA-regulated products into the United States. Just as FDA requires products under FDA's jurisdiction to be properly labeled, so must FDA correctly label Alerts so that the protections embodied in the Administrative Procedure Act may provide the procedural fairness due the regulated importing community. By doing so, FDA will achieve the highest level of protection to consumers in the United States because U.S. importers and foreign manufacturers will better understand how to help ensure that FDA regulated-products they import for commercial U.S. consumption are safe.
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Potential Legal Barriers to Increasing CMS/FDA Collaboration:
The Law of Trade Secrets and Related Considerations
Authors: Stanley S. Wang & John J. Smith
Issue: 58 Food and Drug Law Journal 613-628 (2003).
Closer collaboration between the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) holds the promise of increased efficiency in moving new medical products into broad clinical application. Such collaboration could involve the exchange of confidential sponsor information between the agencies, allowing coverage determinations to be made in a parallel manner with marketing decisions. Any interagency exchange raises the question of violating trade secrets laws and regulations. This article considers the law of trade secrets as it applies to FDA and CMS, and concludes that this body of law does not pose an insurmountable barrier to increased interagency collaboration.
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Prescription Drug Advertising—Should States Regulate What Is False and Misleading?
Author: John Shaeffer
Issue: 58 Food and Drug Law Journal 629-648 (2003).
With the growing pervasiveness of prescription drug advertising, consumer litigation challenging such advertisements as false and misleading is on the rise. Congress has uniquely empowered the Food and Drug Administration (FDA) to regulate the advertisement of prescription drugs, and FDA has enacted detailed regulations governing the form and content of such advertisements. Marketing experts supporting consumer claims, however, have opined that advertisements conforming to FDA regulations are false and misleading due in large part to the format insisted on by FDA. This article traces the history of FDA's jurisdiction over prescription drug advertising and argues that the regulatory nature of state fraud actions against such advertising conflicts with the U.S. Constitution. The article draws sharp distinctions between state product liability actions—where policy supports harmonizing federal and state jurisdiction—and the Commerce Clause and First Amendment concerns facing fraud challenges to prescription drug advertising due to the national pervasiveness of today's media.
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The Final Sampling Regulations of the Prescription Drug Marketing Act Are Alive and Well:
Is Your Sampling Program Compliant?
Author: Jennifer A. Romanski
58 Food and Drug Law Journal 649-660 (2003).
It has been almost three years since the effective date of the Food and Drug Administration's final regulations to the Prescription Drug Marketing Act (PDMA). Pharmaceutical companies, distribution centers, validation vendors, and sample management companies have struggled to implement systems that are compliant with the regulations and, at the same time, enable sample distribution arrangements to be efficient and practical. This article examines the requirements of the PDMA relevant to prescription drug sampling, including requirements for sample distribution by sales representatives and sample distribution by mail, as well as recordkeeping, reporting and audit, and security obligations. This article also highlights nuances in the regulations and some potentially problematic areas that companies may encounter in their efforts to be PDMA-compliant.
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Therapeutic Orphans, Pediatric Victims?
The Best Pharmaceuticals for Children Act and Existing Pediatric Human Subject Protection
Author: I. Glenn Cohen
Issue: 58 Food and Drug Law Journal 661-710 (2003).
In part of the Food and Drug Administration Modernization Act of 1997 (FDAMA) , Congress sought to incentivize research on pediatric populations by providing an additional six months of market exclusivity for a drug when the manufacturer conducts studies of the drug in pediatric populations. This extension would be granted only if the studies "fairly respond" to the Food and Drug Administration's (FDA's) written requests and were conducted in accordance with "commonly accepted scientific principles and protocols." In January 2002, the President signed the Best Pharmaceuticals for Children Act (BPCA), which extends the pediatric extension provisions of FDAMA until October 1, 2007. BPCA has become even more important after a D.C. district court struck down the so-called "Pediatric Rule," an earlier FDA attempt to deal with pediatric research, thus leaving BPCA as FDA's sole means of addressing the problem. While the intent of Congress in the BPCA was to make drugs safer for children, it is an open question whether this is being achieved at the expense of pediatric research subjects. Against the backdrop of federal protection for pediatric research subjects, this article will examine whether the BPCA has incentivized a "race to the bottom" in the conducting of ethical research on children. To the extent it has, Congress should consider amending the BPCA so FDA can grant additional market exclusivity based only on trials conducted in accordance with commonly accepted scientific and ethical principles and protocols.
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Compulsory Licensing to Regulated Licensing:
Effects on the Conflict Between Innovation and Access in the Pharmaceutical Industry
Author: Adi Gillat Adi Gillat
Issue: 58 Food and Drug Law Journal 711-740 (2003).
Balancing interest in innovation incentives and private property rights against the interest in affordable public access to products of innovation is one of the most basic conflicts underlying innovation policy. This article identifies and defines "regulated licensing"—a variation on compulsory licensing that may act as a balancing mechanism between these two interests. The article advances the theory that regulated licensing allows affordable public access by restricting the prices of innovative products while presenting a lesser threat to innovation incentives than that presented by compulsory licensing. Regulated licensing is analyzed in the framework of antitrust enforcement of mergers in intellectual property-intensive industries, focusing on the pharmaceutical industry, where the sensitivity to threats on innovation incentives and the need for public access are amplified due to public health concerns.
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Commentary: Can We Talk?
About Food and Drug Regulation and the First Amendment
Author: Marsha N. Cohen
Issue: 58 Food and Drug Law Journal 741-756 (2003).
Responding to a recent issue (Vol. 58:3) of this Journal discussing the Food and Drug Administration (FDA) and the First Amendment, this commentary urges the agency to develop the factual information necessary to defend vigorously its statutes and regulations. In applying the Central Hudson test to FDA speech, "lawful activity" must be judged from the perspective of FDA's statutes and authority. Using that appropriate criterion, promotion of off-label drug use—in contrast to prescription of drugs off-label—does not concern "lawful activity." Speech is regularly used as a statutory "boundary marker," as Congress attempted to do in the pharmacy compounding statute, without success. To maintain consumer protection in the face of strict interpretation of the First Amendment, Congress and FDA need to consider conduct-based regulatory restrictions, some of which are set forth.
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