Volume 63 Issue 3
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Table of Contents
by
Grant H. Castle, Partner in the law office of Covington & Burling, London, England
Brian Kelly, Associate in the law office of Covington & Burling, London, England
63 Food and Drug Law Journal 601-622 (2008).
Pharmacovigilance is a global public health activity. Global harmonization is, however, under threat because of differences in the way different jurisdictions interpret, implement and follow international safety reporting standards. These different interpretations can have adverse consequences for pharmaceutical companies marketing products in several jurisdictions, as regulators can, and will, adopt different and inconsistent solutions to potential safety issues. To avoid such consequences, international standards must be implemented into national laws consistently.
In addition, the way products are identified in safety reports is a major issue. Effective pharmacovigilance requires global harmonization of nomenclature. Medicinal products are recognized globally by their international non-proprietary name (INN). For safety reasons, however, European regulators recently proposed that doctors report biological medicinal products by brand name. Such an approach would be inconsistent with the global method of identifying medicinal products and should be resisted. How can global safety monitoring and reporting work if those involved do not even speak the same language?
by
Kai P. Purnhagen, Researcher in law, EUI and Lecturer in European law, University of Lucerne, Switzerland
63 Food and Drug Law Journal 623-645 (2008).
Pharmaceutical Companies are highly globalized. This widening of drug markets leads to an erosion of the national government‘s legislative powers. With trials and marketing of compounds and pharmaceuticals carried out in different countries, ensuring safety and effectiveness of drugs becomes increasingly problematic.
Thus, international pharmaceutical approval harmonization as well as drug monitoring, belongs paramount. One way of solving this problem might be to model an international pharmaceutical authorization system on the European Decentralized Procedure with involvement of the International Conferences of Harmonisation. That’s the focus of this article.
by
Judith K. Meritz, Partner in the Blank Rome LLP Health Law Practice Group, Washington, DC
Tyechia L. White, 2009 JD Candidate, Howard University School of Law, Washington, DC
63 Food and Drug Law Journal 647-656 (2008).
Are drug and device products less safe today due to increased globalization? Does the fact that more products are either fully manufactured overseas or are manufactured in the United States but contain foreign components create an exponential increase in the challenges confronted? Is there anything different about medical device products that would make it more difficult to ensure product safety and suggests that a medical device is more or less inherently safe than a drug or a biologic? What are the factors that affect this answer?
This article discusses stakeholders’ ability to protect the public health as goods and services are increasingly manufactured and distributed worldwide. The article discusses the Food and Drug Administration’s ability to ensure the safety of foreign manufactured products and addresses the disagreements that come to the surface when trying to balance cost-effectiveness with consumer safety.
The article also focuses on efforts at harmonization, specifically the Global Harmonization Task Force, which relies on international standards to promote convergence of technical requirements and analyzes the situation surrounding import alerts and the Interagency Working Group on Import Safety.
Certification v. Importer Accountability as Models for Assuring the Safety of Internationally Traded Foods
by
David Plunkett, Senior Staff Attorney at the Center for Science in the Public Interest, Washington, DC
Caroline Smith DeWaal, Director of the Food Safety Project at the Center for Science in the Public Interest, Washington, DC
63 Food and Drug Law Journal 657-664 (2008).
Assuring imported food meets U.S. food safety standards presents regulators with the difficult task of enforcing domestic standards in a foreign jurisdiction. Certification and accountability models offer dynamically different approaches to solving the dilemma of enforcing laws on extra-jurisdictional suppliers. The U.S. Department of Agriculture uses a certification system that attempts to prevent problems by requiring a foreign supplier to operate under equivalent or better standards as a condition of entering the U.S. market. The European Commission has adopted an accountability system (for non-animal foods) that leaves prevention to the importing firm, while giving regulators authority to recover the societal costs of a foreign supplier’s failure from the domestic importer. As efforts to reform U.S. food safety laws progress, the question arises which model works best for the Food and Drug Administration (FDA) regulated food? USDA’s certification system works because it pre-dates the modern global food system.
Without the same historical precedent, FDA oversees millions of food import line items arriving from hundreds of thousands of suppliers located around the world. How can FDA institute a certification program, especially one that will not be too costly or burdensome on trade? What are the true costs and benefits of such a system, or is it merely a diversion of FDA resources away from front line inspection? Meanwhile, accountability systems rely on enforcement, which has its own costs, and use consumers as the “canaries in the coal mine” for identifying failures. Can importers really be held accountable, and how will the public react to being the first line for detection of disease outbreaks? This article analyzes the two systems looking at the pros and cons of both in isolation and together, and makes recommendations on how FDA can improve its oversight of imports.
Globalization of Food Safety
by
Obijiofor Aginam, Professor of Law, Carleton University, Ottawa, Canada
63 Food and Drug Law Journal 665-672 (2008).
This article focuses on the linkages between trade liberalization and food safety. It is not always easy to maintain a balance between market access and protection of public health as countries engages in trade. Food safety concerns specifically raise complex challenges for the regulation of risk. This article explores the challenges of globalization of food safety concerns driven by economic globalization and how the Agreement on Sanitary and Phyto-sanitary Measures (SPS) enforced by the World Trade Organization (WTO) addresses these challenges.
Focusing on cases decided by the WTO Dispute Settlement Bodies on SPS disputes, this article argues that because the world lacks a “cohesive, epistemic community on issues of transnational biotechnology,” WTO jurisprudence should create the necessary flexibility for the application of other multilateral norms that protect the environment and human health. While the relevance of science in SPS disputes is indisputable, instances of trade-related food-borne outbreaks fraught with uncertainties abound. In such instances, this article argues, the Dispute Settlement Bodies of the WTO should re-consider the relevance of, and possible ways, to apply the “norm” of the precautionary principle.
by
Carolyne R. Hathaway, Partner in the law firm of Latham & Watkins LLP, Washington, DC
John R. Manthei, Partner in the law firm of Latham & Watkins LLP, Washington, DC
J. Ben Haas, Associate in the law firm of Latham & Watkins LLP, Washington, DC
Cassie A. Scherer, Associate in the law firm of Latham & Watkins LLP, Washington, DC
63 Food and Drug Law Journal 673-682 (2008).
The increasing costs of clinical development and the length of the drug development process have lead many United States pharmaceutical companies to look overseas to conduct their clinical trials. Conducting clinical trials in foreign jurisdictions may offer benefits to pharmaceutical companies, including easier access to potential subjects and lower costs. However, in considering whether to conduct a clinical trial overseas, sponsors also need to be aware of the potential risks and pitfalls that they may encounter.
This article examines the potential benefits and corresponding risks associated with conducting trials in foreign jurisdictions, particularly the nations in Central and Eastern Europe. It provides a brief summary of the key legal and regulatory requirements with which the sponsor will need to comply if it decides to conduct a clinical trial abroad. The authors also offer practical considerations and recommendations for sponsors, with examples to illustrate key points.
Harmonic Convergence or Convergent Evolution?
by
Laura B. Faden, Senior Research Analyst at the Tufts Center for the Study of Drug Development, Tufts University, Boston, MA
Christopher-Paul Milne, Associate Director of the Tufts Center for the Study of Drug Development, Tufts University, Boston, MA
63 Food and Drug Law Journal 683-700 (2008).
In light of the heightened international awareness of postapproval safety of drugs and biologicals, the three major pharmaceutical markets ― United States, European Union and Japan ― all recommend and/or require pharmacovigilance activities for the detection of safety signals postapproval.
These activities are split into three broad categories: postmarketing surveillance, risk management and postapproval research. Faced with similar product approvals and safety issues, are the three regions moving together towards a common approach to postmarket safety (harmonic convergence) or separately finding their own way to the same end (convergent evolution)? This paper describes and compares the components of the pharmacovigilance systems in each of the three regions.
Practice in Developing Countries
by
Segev Shani, Vice President for Medical and Regulatory Affairs in the Neopharm Group and a Lecturer in the Department of Health Systems Management, Faculty of Health Sciences, Ben-Gurion University, Beer Sheva, Israel
Zohar Yahalom, Independent Legal Counselor for the pharmaceutical industry, Yahalom Law Offices, Tel Aviv, Israel
63 Food and Drug Law Journal 701-712 (2008).
The discipline of pharmacovigilance is based on the reporting of a drug’s adverse events. The regulatory authorities in the developed world, led by the Food and Drug Administration and the European Medicine Evaluation Agency require pharmaceutical companies to report all adverse events related to their products wherever they operate and sell their products. However, in many developing countries pharmacovigilance is not necessarily a national priority as there are other public health issues, and even when there is a regulatory requirement for adverse event reporting, the scarcity of resources and lack of enforcement might limit the magnitude of safety reporting.
As part of globalization, pharmaceutical companies are operating in most of the world through their own local affiliates or through local agents. Therefore, the authors suggest that, as pharmaceutical companies apply the strictest pharmacovigilance practice all over the organization, they do so particularly in developing countries, raising awareness of safety reporting by providing financial incentives when conducting clinical trials or by providing the expertise and resources to train local professionals.
by
Roseann B. Termini, Food and Drug Lawyer and Professor of food and drug law courses online
Christine A. Kelly-Miller, 2008 JD candidate, Widener University School of Law
63 Food and Drug Law Journal 713-722 (2008).
Depression in children is a controversial topic in the United States. It is an even more contentious subject when one looks at mental healthcare for children in developing nations, such as Pakistan.
This article explores the cultural impact on utilization of antidepressants prescribed to children in the United States and Pakistan. The diagnosis and treatment of childhood depression has become more complicated as additional antidepressants become available on the market and their efficacy, as well as their potential for serious side effects, is fiercely debated.
Yet, the commonality between the United States and Pakistan is that, despite which country a child is from, perhaps the largest victim is the smallest. This article also includes a description of the legal landscape that plaintiffs have at their disposal in the event of negative outcomes.
by
Gregory V. Page, Managing Director, Navigant Counseling, New York, NY
Mark A. Waring, Associate Director, Navigant Counseling, New York, NY
Geoffrey R. Kaiser, Managing Director, Navigant Counseling, New York, NY
Kevin Cornish, Managing Director, Navigant Counseling, New York, NY
63 Food and Drug Law Journal 723-734 (2008).
What keeps life science chief executives up at night when it comes to safety in an era of globalization? One answer is certainly executive liability, particularly as it relates to non-compliance and government regulatory actions. The Food and Drug Administration always has had the ability and authority to hold Chief Executive Officers and Board members personally liable and accountable for the actions of their organizations, both in a civil and criminal context. Although to date the number of personal liability convictions against pharmaceutical corporate executives has been relatively low, recent court cases and federal enforcement agency actions indicate that this situation may be about to change.
This article reviews the current regulatory and legal landscape regarding personal liability in the life science sector in an era of globalization. It discusses emerging trends and potential pitfalls regarding the role of senior executives in establishing the necessary compliance culture needed to function effectively within today’s regulatory environment. Finally, it concludes by presenting suggestions for cultural and organizational change, establishing the correct “tone at the top” and the compliance roles that senior executives and board members must play.