Volume 60 Issue 4
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Table of Contents
> Responding to a Form 483 or Warning Letter: A Practical Guide
by Richard M. Cooper, Partner in the law firm of Williams & Connolly LLP, Washington, D.C.
and
John R. Fleder, Director in the law firm of Hyman, Phelps & McNamara, P.C., Washington, D.C.
> Amicus Curiae Efforts to Reform Product Liability at the Food and Drug Administration: FDA's Influence on Federal Preemption of Class III Medical Devices and Pharmaceuticals
by Mark C. Levy, Partner with the law firm of Saul Ewing LLP, Philadelphia, PA and Chair of the firm's Litigation and Risk Management Life Sciences Industry Service Team
and
Gregory J. Wartman, Associate with the law firm of Saul Ewing LLP, Philadelphia, PA.
> Realizing the Potential for Biomarkers in Imaging: Background and Legal Basis
by Jennifer A. Henderson, Acting Director of Regulatory Affairs, Center for Integration of Medicine and Innovative Technology, Cambridge, MA
and
John J. Smith, Counsel in the law firm of Hogan & Hartson, L.L.P., Washington, D.C. and Advisor, Center for Integration of Medicine and Innovative Technology, Cambridge, MA.
> Major New Initiatives Require Increased Disclosure of Clinical Trial Information
by Marc J. Scheineson, head of the food and drug practice in the Washington, D.C. office of Alston & Bird LLP and a former Food and Drug Administration Associate Commissioner
and
M. Lynn Sykes, Counsel in the Washington, D.C. office of Alston & Bird LLP.
> Hoarding Away Science: Towards a More Transparent View of Health and Online Registries
for Independent Postmarket Drug Research
by James M. Wood, Partner in the law firm of Reed Smith LLP, Oakland, CA
and
Roxanne M. Gariby, a 2007 J.D. candidate at the University of California, Boalt Hall School of Law.
> The World Health Organization's Global Strategy on Diet, Physical Activity, and Health:
Turning Strategy Into Action
by Emily Lee, a 2006 J.D. candidate Harvard Law School. This article received an Honorable Mention in the 2005 H. Thomas Austern Memorial Writing Award Competition (long papers).
> Only a Matter of Time: Lessons Unlearned at the Food and Drug Administration Keep Americans at Risk
by Sue McGrath, a May 2005 graduate of Cleveland-Marshall College of Law who was admitted to the Ohio Bar in November 2005.
Responding to a Form 483 or Warning Letter: A Practical Guide
Authors: Richard M. Cooper & John R. Fleder
60 Food and Drug Law Journal 479-494 (2005).
Almost every company regulated by the Food and Drug Administration (FDA) will, at some point in its history, have need to respond to an FDA Form 483 (notice of inspectional observations) and/or to an FDA warning letter (a publicly issued threat of serious consequences if compliance is not achieved). This article proposes an approach to developing an effective response and suggests ways to demonstrate understanding of deficiencies, commitment to addressing them, and mobilization of the resources needed to address them effectively. It also discusses the overall tone of a response, whether to agree or disagree with FDA's observations or criticisms, consideration of related proceedings, and the making of commitments to FDA. Finally, the article addresses some practical aspects of a response and the relation of a response to a request for a meeting with FDA.
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Amicus Curiae Efforts to Reform Product Liability at the Food and Drug Administration:
FDA's Influence on Federal Preemption of Class III Medical Devices and Pharmaceuticals
Authors: Mark C. Levy & Gregory J. Wartman
60 Food and Drug Law Journal 495-510 (2005).
Since President George W. Bush took office in 2000, the Food and Drug Administration (FDA) has used amicus curiae briefs in medical device and pharmaceutical litigation to advocate greater preemption protection for device and drug manufacturers. Reversing the position it took during the Clinton Administration, FDA has posited that the premarket approval (PMA) process is so comprehensive that there is no need for an additional layer of consumer protection.
These amicus curiae efforts have been successful, at least in the medical device context, at convincing courts to rule in favor of preempting tort claims against manufacturers. Recently, in Horn v. Thoratec, Inc., the Third Circuit Court of Appeals gave substantial weight to FDA's amicus curiae brief, which argued that the PMA process for Class III medical devices is a specific federal requirement that preempts different or additional state tort claims. Two other circuits have followed suit and given preemptive effect to the PMA and PMA supplement processes. Amicus curiae briefs in pharmaceutical litigation have not been as successful, but nevertheless they have provided drug manufacturers with a framework to argue in favor of preemption. This article analyzes the reform impact FDA's amicus curiae briefs have had on the tort liability of both medical device and prescription drug manufacturers.
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Realizing the Potential for Biomarkers in Imaging: Background and Legal Basis
Authors: Jennifer A. Henderson & John J. Smith
60 Food and Drug Law Journal 511-524 (2005).
Establishing the safety and effectiveness of new drug and device-based therapies is a lengthy and costly exercise, impacting the pace of innovation. Effective use of imaging biomarkers holds the promise of improving the product development process, maintaining the safety and effectiveness standards established by the Federal Food, Drug, and Cosmetic Act (FDCA) in a less costly, more cost-efficient manner. The FDCA, as amended, as well as applicable Food and Drug Administration (FDA) regulations, supports the responsible use of surrogate endpoints, and by extension imaging biomarkers. It is up to FDA, the regulated industry, and the medical community to work together to ensure that the potential of imaging biomarkers can be realized.
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Major New Initiatives Require Increased Disclosure of Clinical Trial Information
Authors: Marc J. Scheineson & M. Lynn Sykes
60 Food and Drug Law Journal 525-546 (2005).
The next wave of undeserved criticism against medical product manufacturers has been allegations of selective disclosure of negative clinical information regardless of the validity of the data. The issue hit the front pages in debates about whether certain antidepressants increase suicidal thoughts in adolescents. The perception that companies squelch the publication of unfavorable data was further reinforced when Cox-2 inhibiters were withdrawn from the market, even though the pivotal research was broadly disseminated, and the products were promptly withdrawn until questions could be addressed. Required listings on clinicaltrials.gov were found to be sporadic and inconsistent.
In 2005, a number of states enacted, or proposed, requirements that manufacturers disclose more information about the clinical trials they conduct or fund. Congress also has proposed legislation requiring broader disclosure of clinical trial data. In addition, industry participants and the Pharmaceutical Research and Manufacturers of America instituted voluntary programs for greater transparency and disclosure. This article discusses the existing disclosure requirements and major initiatives underway to encourage increased disclosure of clinical trial information. The authors analyze the approach taken by major drug- and device-makers to meet their disclosure obligations while simultaneously protecting their most sensitive scientific information.
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Hoarding Away Science: Towards a More Transparent View of Health and Online Registries
for Independent Postmarket Drug Research
Authors: James M. Wood & Roxanne M. Gariby
60 Food and Drug Law Journal 547-568 (2005).
The Food and Drug Administration (FDA) and industry have created numerous resources so that as risks become known they can be made available not only after a therapy has been approved but also while it is in the development stage. One segment of the healthcare group, independent researchers and academics, however, has not shared in creating full transparency of research. Claiming that their work is entitled to the protection of the U.S. Constitution and academic freedom, many who publish findings that therapies might not hold the promise believed to exist at the time of approval resist having their research publicized and investigated. This article details the history of the development of full transparency concerning a therapy's benefits, pre- and post-approval. It also highlights the fact that product liability litigation frequently has been driven by research that has as its sole purpose to fuel lawsuits. In other instances, independent, yet incomplete or inconclusive, research serves to perpetuate litigation that might otherwise evaporate. Finally, the article urges that all investigations into the benefits and risks of a therapy be subject to the same rules of transparency as those required by FDA and adopted by many in industry.
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The World Health Organization's Global Strategy on Diet, Physical Activity, and Health:
Turning Strategy Into Action
Author: Emily Lee
60 Food and Drug Law Journal 569-602 (2005).
The World Health Organization (WHO) developed the Global Strategy on Diet, Physical Activity, and Health in response to a request from Member Nations to address the global epidemic of noncommunicable diseases such as obesity and other diet- and inactivity-related diseases. While the ultimate success of the Global Strategy is uncertain at this stage, the forces of globalization, international trade, and transnational marketing continue to undermine national laws and policies aimed at addressing the epidemic. An increased legal role for the WHO in this area is imminent in light of the need for an international organization to catalyze national action, exert control over certain practices of transnational corporations, and advocate for health-promoting policies in international trade systems.
This article focuses on defending the need for a centralized international instrument in addressing the increased prevalence of global obesity and diet- and inactivity-related diseases and defining the ambit of the WHO's legislative powers in the area of food. It also offers some insight into the question of how WHO-based legal instruments could assist the worldwide fight against diet- and inactivity-related diseases. The spectrum of regulation ranges from binding treaties to voluntary codes of practice, and includes familiar international law models as well as nontraditional solutions such as the use of the WHO as a judicial organ in international trade disputes. It would be prudent for the WHO to explore a multipronged approach to address the complexity of diet- and inactivity-related diseases.
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Only a Matter of Time: Lessons Unlearned at the Food and Drug Administration
Keep Americans at Risk
Author: Sue McGrath
60 Food and Drug Law Journal 603-624 (2005).
The Food and Drug Administration (FDA) has seen the direction and the extent of its power change in response to a series of human mishaps that established unequivocally the need for regulation to protect the public from two of mankind's greatest enemies: ignorance and greed. While advances in science and technology have virtually eliminated the dangers from ignorance, the development of a multibillion dollar drug industry provides ample incentive for some to place dollars over human welfare. Because of this financial incentive, the pharmaceutical industry has pressured FDA to make premature, dangerous, and sometimes fatal decisions.
This article reviews the development of FDA's drug and device approval processes and the influence the pharmaceutical industry has exerted on the agency to approve and keep drugs and medical devices on the market even when they proved to be ineffective, dangerous, or lethal. A history of drug mishaps and human tragedy is useless, however, unless reoccurrences are prevented and the flaws in current FDA regulations that still provide the pharmaceutical industry with sufficient opportunities for abuse and exploitation are corrected. The thesis of this article is that FDA must be strengthened and allowed to operate without undue pressure from the pharmaceutical industry so that the agency can focus on its primary mission of protecting the U.S. public.
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