Volume 60 Issue 2
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Table of Contents
> Remarks of the Acting FDA Commissioner: The Food and Drug Law Institute's 48th Annual Conference
by Lester M. Crawford, D.V.M., Ph.D., Acting Commissioner of Food and Drugs, Food and Drug Administration, Rockville, MD.
> Remarks Delivered at the Food and Drug Law Institute's 48th Annual Conference
by The Honorable Michael B. Enzi (R-WY), U.S. Senator and Chairman of the Senate Committee on Health, Education, Labor and Pensions.
> Developments in Food and Drug Law
by Gerald F. Masoudi, Deputy Chief Counsel, Food and Drug Administration, Rockville, MD.
> Remarks at the Food and Drug Law Institute's 48th Annual Conference
by Steven M. Niedelman, Assistant Commissioner for Regulatory Affairs, Office of Regulatory Affairs, Food and Drug Administration, Rockville, MD.
> Drug Regulation 2056
by Clement Bezold, Ph.D., President, Institute for Alternative Futures, Alexandria, VA
and
Jonathan Peck, Managing Director, Institute for Alternative Futures, Alexandria, VA
> Challenges in Regulating Breakthrough Medical Devices
by Neal I. Muni, M.D., MSPH, Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA), Rockville, MD
and
Thomas P. Gross, M.D., MPH, CDRH, FDA, Rockville, MD
and
Ashley B. Boam, M.S.B.E., CDRH, FDA, Rockville, MD
and
Stanley Wang, M.D., J.D., MPH, affiliated with the Department of Cardiology, University of North Carolina, Chapel Hill, NC
and
Bram D. Zuckerman, M.D., CDRH, FDA, Rockville, MD
> Reflections on Historical, Scientific, and Legal Issues Relevant to Designing Approval Pathways for Generic Versions of Recombinant Protein-Based Therapeutics and Monoclonal Antibodies
by David M. Dudzinski,, who will receive his M.D. degree from Harvard Medical School in June 2006 and is a cum laude graduate of Harvard Law School . A previous version of this article won First Place in the Food and Drug Law Institute's (FDLI's) 2003-2004 H. Thomas Austern Memorial Writing Awards Competition (long papers).
> The Prescription Drug User Fee Act: Is a Faster Food and Drug Administration Always a Better Food and Drug Administration?
by James L. Zelenay, Jr., a 2004 graduate of Harvard Law School currently working as a law clerk in the Central District of California. A previous version of this article won Second Place in the Food and Drug Law Institute's (FDLI's) 2003-2004 H. Thomas Austern Memorial Writing Awards Competition (long papers).
Remarks of the Acting FDA Commissioner: The Food and Drug Law Institute's 48th Annual Conference Author: Lester M. Crawford
60 Food and Drug Law Journal 99-102 (2005).
As the Food and Drug Administration (FDA) approaches its Centennial celebrations, this is a good moment to reflect on past achievements and look ahead to the future of the agency. This is the fourth time Dr. Crawford has been at FDA, and the second time at the helm of the agency; he currently serves as the Acting Commissioner of Food and Drugs. In this article, he expresses his belief that the present FDA, more than ever, understands the agency's mission to protect as well as advance the nation's health. This article provides a glimpse into the future of FDA, and outlines some of the agency's key priorities for the coming years.
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Remarks Delivered at the Food and Drug Law Institute's 48th Annual Conference
Author: Michael B. Enzi
60 Food and Drug Law Journal 103-106 (2005).
Senator Michael B. Enzi (R-WY) is Chairman of the U.S. Senate's Health, Education, Labor and Pensions Committee. This article is based on remarks Senator Enzi delivered at the 48th Annual Conference of the Food and Drug Law Institute in Washington, D.C. The theme of the conference, and of his talk, was "Preparing for the Next Century of Food and Drug Regulation." Senator Enzi laid out his health agenda for the 109th Congress, and focused specifically on plans to legalize drug importation, improve drug safety, and strengthen our national biodefense.
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Developments in Food and Drug Law
Author: Gerald F. Masoudi
60 Food and Drug Law Journal 107-116 (2005).
This article shares the views of the Acting Chief Counsel of the Food and Drug Administration (FDA) regarding the most important recent developments in food and drug law. In February 2005, FDA issued the first Emergency Use Authorization (EUA) under the Bioshield Act. In December 2004, FDA issued a final rule that requires the establishment and maintenance of records by "persons" who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States. In September 2004, FDA proposed a rule that would require measures to prevent salmonella enteritis from contaminating shell eggs—a step toward FDA's first comprehensive on-farm regulation. FDA also has made efforts to protect American consumers from the public health risks associated with "mad cow" disease. In February 2004, FDA published its Ephedra Rule, which concludes that dietary supplements containing ephedrine alkaloids are adulterated under the Dietary Supplement Health and Education Act. FDA has litigated a number of cases involving First Amendment issues, and these decisions have affected the regulation of the entire spectrum of products within FDA's jurisdiction. The agency was required to resolve several complex issues regarding the interplay between pediatric exclusivity and generic drug approvals, and is involved in several cases that challenge the nature and scope of the agency's authority in the area of pharmacy compounding.
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Remarks at the Food and Drug Law Institute's 48th Annual Conference
Author: Steven M. Niedelman
60 Food and Drug Law Journal 117-126 (2005).
The Food and Drug Administration's (FDA's) Assistant Commissioner for Regulatory Affairs addresses the topic of " Preparing for the Next Century of Food and Drug Regulation." The resonating theme of this article is the incorporation of "risk-based principles" into as many of the agency's activities as possible. FDA is committed to the consistent adoption of risk management principles throughout all of the agency's components and functions. FDA has initiated a critical, comprehensive review of its practices relative to planning and prioritizing its inspectional work on a risk-based model; conducting inspections as efficiently and as effectively as possible; utilizing risk management principles; and achieving compliance with the Federal Food, Drug, and Cosmetic Act. These efforts signal the agency's recognition that sound compliance and inspection programs will provide the foundation for FDA's efforts to protect the public health.
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Drug Regulation 2056
Authors: Clement Bezold & Jonathan Peck
60 Food and Drug Law Journal 127-136 (2005).
By the year 2056, food and drug regulation will have changed due to developments such as the World Wide Web, systems biology, and "predict-and-prevent medicine." We may not need food and drug regulation as we know it. With medicine redefined by increased biological knowledge, collaborative efforts from many healthcare providers across multiple disciplines will anticipate disease before people get sick. Ultimately, a knowledgeable public, using Web-based tools, can achieve an equality of power between producers and themselves as consumers of foods and drugs. Consumer choices can create incentives to maintain safety, efficacy, cost-effectiveness, and value in the market. This U.S. market increasingly will be part of a global system. A global network of consumers and patient groups will scan for those who endanger health with false or misleading knowledge and will be backed up by government regulators. Alternative scenarios are possible, but the authors' preferred future is one in which global knowledge informs personal choice that leads to smarter, healthier markets.
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Challenges in Regulating Breakthrough Medical Devices
Authors: Neal I. Muni, Thomas P. Gross, Ashley B. Boam, Stanley Wang & Bram D. Zuckerman
60 Food and Drug Law Journal 137-142 (2005).
The Center for Devices and Radiological Health of the Food and Drug Administration (FDA) is tasked with the review of medical devices to ensure their safety and effectiveness in both pre- and post-approval settings. For breakthrough medical device technologies, regulation is an especially challenging task in that any actions by FDA can have profound public health consequences. FDA must weigh the risks and benefits of medical devices throughout a device's product lifecycle, including preclinical testing, clinical study, approval, and incremental improvement phases. This article provides insight into the regulatory decisionmaking process for breakthrough medical devices, to better illustrate the issues the agency faces when considering regulatory actions.
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Reflections on Historical, Scientific, and Legal Issues Relevant to Designing Approval Pathways
for Generic Versions of Recombinant Protein-Based Therapeutics and Monoclonal Antibodies
Author: David M. Dudzinski
60 Food and Drug Law Journal 143-260 (2005).
The Food and Drug Administration (FDA) approves generic drugs for marketing in the United States. Thus, FDA also necessarily bears the final responsibility for mediating the constant war between the research-based pharmaceutical industry and the generic drug industry. Significant public policy concerns weigh in this balance, namely future innovation and the development of new therapeutics versus less expensive drug costs and increased access to medicines. The next chapter in this war—already begun—is the conflict over generic biotechnology products. This analysis aims to construct an authoritative historical background on both the relevant law and science; analyze cases and FDA interpretations relevant to the regulation of protein biologics and their possible generic approval; and offer scientific insights useful to Congress or FDA in implementing a scheme of generic protein-based therapeutics.
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The Prescription Drug User Fee Act:
Is a Faster Food and Drug Administration Always a Better Food and Drug Administration?
Author: James L. Zelenay, Jr.
60 Food and Drug Law Journal 261-338 (2005).
In 1992, Congress passed the Prescription Drug User Fee Act (PDUFA I). This legislation called for the Food and Drug Administration (FDA) to charge the pharmaceutical industry for certain services and to allot the fee revenues to "performance goals" aimed at speeding up the drug approval process. This legislation was authorized for only five years. Praising PDUFA I's success but aware of its failures, Congress passed the Food and Drug Administration Modernization Act of 1997, Title I of which re-authorized an amended PDUFA bill for another five years (PDUFA II). Facing the same circumstances five years later, Congress passed the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Title V of which re-authorized a further-amended PDUFA bill for yet another five years (PDUFA III). This article traces the historical development of these three different versions of PDUFA, noting in particular how each one was amended to avoid its predecessor's failures. The article then critiques PDUFA III and argues that, while it fails to go far enough in attempting to avoid PDUFA II's failures, it goes too far in that it further entrenches FDA's dependence on the same industry that the agency is charged with regulating vigorously.
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