Volume 62 Issue 3
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Table of Contents
> Cause and Effect? Assessing Postmarketing Safety Studies as Evidence of Causation
in Products Liability Cases
by Lance L. Shea, Partner, Fulbright & Jaworski L.L.P., Washington, DC
and
Andre Hanson, Senior Associate, Fulbright & Jaworski L.L.P, Minneapolis, MN
and
Tiffany M. Guglielmetti, Associate, Fulbright & Jaworski L.L.P., Washington, DC
and
Kimberly Levy, Associate, Fulbright & Jaworski, L.L.P., Washington, DC
> The Risk of Risk Reduction: Can Postmarket Surveillance Pose More Risk than Benefit?
by Ralph F. Hall, Visiting Associate Professor of Law, University of Minnesota, Counsel, Baker & Daniels LLP, Indianapolis, Indiana and Washington DC, CEO, MR3 Medical, LLC
> Pharmaceutical Postmarket Review: Fact or fiction?
by Stephen J. Schanz, Teaching Assistant Professor, Department of Management, Innovation & Entrepreneurship, College of Management,North Carolina State University
> Drug Safety: A Contrarian’s Point of View
by Barton Cobert, Vice President, Global Regulatory Initiatives and Pharmacovigilance at Mediata Solutions Worldwide, New York City, NY
> Postmarketing Pharmacovigilance Compliance in the Midst of Regulatory Uncertainty
by Stephen A. Goldman, Managing Member, Stephen A. Goldman Consulting Services, L.L.C., Morris Plains, NJ
> Red Sky in the Morning: Modifying Prescription Drug Labels as a Result of Postmarket Surveillance
by Jill D. Jacobson, trial lawyer, Bowman and Brooke LLP, Richmond, VA
and
David Feigal, Partner, NDA Partners, Falls Church, VA
> The Drug Safety System Conundrum
by Thomas N. Tiedt, , Director, Med-Tox Group, Lakewood Ranch, FL
> Pin the Tail on the Other Donkey: Allocating and Avoiding Injury Losses after Drug or Device Approval
by James T. O’Reilly, Professor of Law, College of Law, University of Cincinnati
> Medical Device Reporting: Issues with Class III Medical Devices
by Jeffrey Zigler, Regulatory Consultant, Musculoskeletal Clinical Regulatory Advisers, Washington, DC
and
John Walsh, Regulatory attorney, Synthes, Inc., West Chester, PA
And
Jack Zigler, Spine Surgeon, Texas back Institute, Plano, TX
> Medical Device Recalls from 2004-2006: A Focus on Class I Recalls
by Marta L. Villarraga, Principal Engineer at Exponent, Inc., Philadelphia, PA
and
Heather L. Guerin, Engineer at Exponent, Inc., Philadelphia, PA
and
Tack Lam, Managing Engineer at Exponent, Inc., Los Angeles, CA
> Medical Device Safety: FDA’s Postmarket Transformation Initiative
by Daniel Schultz, Director, Center for Devices and Radiological Health, FDA
> Medical devices Post-Approval Studies Program: Vision, Strategies, Challenges and Opportunities
By Danica Marinac-Dabic, Chief, Epidemiology Branch, Division of Postmarket Surveillance, office of Surveillance and Biometrics, Center for Devices and rAdiological Health, Food and Drug Administration
and
Michele Bonhomme, Team Leader, Epidemiology Branch, Divison of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration
and
Nilsa Loyo-Berrios, Team Leader, Epidemiology Branch, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration
and
Thomas Gross, Director, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration
and
Robert Ciperson, Staff Fellow, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration
and
Susan Gardner, Director, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration
and
Michael Marcarelli, Director, Bioresearch Monitoring, Office of Compliance, Center for Devices and Radiological Health, Food and Drug Administration
> Strategy for Surveillance of Adverse Drug Events
By Roselie A. Bright, Chief, Surveillance and Data Analysis Branch, Division of Compliance Risk Management and Surveillance, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
Cause and Effect? Assessing Postmarketing Safety Studies as Evidence of Causation
in Products Liability Cases
Authors: Lance L. Shea, Andre Hanson, Tiffany M. Guglielmetti and Kimberly Levy
62 Food and Drug Law Journal 445-472 (2007).
FDA receives and generates information from anecdotal reports, clinical trial results and epidemiology study results to monitor postmarketing drug safety issues. Today, all entities involved in pharmaceutical development, manufacturing and marketing—lawmakers, regulators, manufacturers, marketers, research institutions and medical/scientific journals—are under increased scrutiny over drug safety.
Such scrutiny can be expected to generate drug safety information additional to, and possibly different from, the information that currently is available. Regardless, the types of data received by FDA likely will continue to be generated by the anecdotal reports, clinical trials and epidemiology studies.
With this increased scrutiny and the growth in litigation over drug safety issues, we can expect courts to be called upon to assess such data as evidence in products liability lawsuits. This article discusses certain study design features as indicia of study validity in light of that which must be proven in order to maintain a legal action and what must be shown before the data can be admitted as evidence in such an action.
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The Risk of Risk Reduction: Can Postmarket Surveillance Pose More Risk than Benefit?
Author: Ralph F. Hall
62 Food and Drug Law Journal 473-492 (2007).
The question raised in this article is whether the risks inherent in this current drive to strengthen the postmarket surveillance system have been adequately assessed. Are we prepared for the results of these new initiatives? This article contends that: 1) there are significant risks flowing from the proposed enhanced postmarket surveillance system, 2) these risks have not been adequately considered, and 3) we should stop, take a breath and address these issues before proceeding.
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Pharmaceutical Postmarket Review: Fact or Fiction?
Author: Stephen J. Schanz
62 Food and Drug Law Journal 493-500 (2007).
FDA and the pharmaceutical industry have come under increased scrutiny relating to the performance of postmarket studies conducted after the agency has approved a drug for public use. Concerns have focused on reports that the majority of postmarket studies to be undertaken have not been completed on schedule.
This, in turn, has raised concern over the FDA’s ability to enforce such studies and whether legislative changes are necessary.
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Drug Safety: A Contrarian’s Point of View
Author: Barton Cobert
62 Food and Drug Law Journal 501-512 (2007).
Drug safety and pharmacovigilance are now urgent topics throughout the world, getting much press and media attention, particularly in North America. However, the attention they are getting is largely negative. All parties are being maligned: the pharmaceutical companies, FDA, drugs themselves, their prices, doctors who prescribe them, Medicare’s (doughnut) drug plan and conflicts of interest of all parties. This paper explores why this is happening and its relevance for future drug policy.
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Postmarketing Pharmacovigilance Compliance in the Midst of Regulatory Uncertainty
Author : Stephen A. Goldman
62 Food and Drug Law Journal 375-386 (2007).
Ongoing analysis of the national program for drug safety already has led to implemented and proposed changes intended to enhance FDA’s ability to protect public health, including increased funding for new personnel, upgraded methods and available data and organizational and structural modifications. It also is conceivable that FDA may be granted authority to mandate both labeling changes and studies designed to monitor known and discover unknown safety concerns in the postmarketing realm.
However, numerous investigations of FDA’s postmarketing drug safety program, scientific literature and associated media coverage have almost completely ignored both the critical role of FDA’s inspectional programs for pharmaceutical adverse event reporting compliance, and the significant impact of delays in finalization and release of needed rules, regulations and guidances related to drug safety.
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Red Sky in the Morning: Modifying Prescription Drug Labels as a Result of Postmarket Surveillance
Authors: Jill D. Jacobson and David Feigal
62 Food and Drug Law Journal 529-546 (2007).
In 2005, in the wake of several high-profile drug safety issues, FDA announced a wave of new programs aimed at strengthening the agency’s post-market monitoring of drug safety. Among the changes was the agency’s publication of a guidance, “Drug Safety Information—FDA’s Communication to the Public,” in which FDA announced its policy of making public “emerging drug safety information.”
Prescription drug manufacturers have expressed concern about the publication of such information and the potential for it to induce lawsuits alleging failure to warn about the risks disclosed. This article explores the current landscape of FDA regulations regarding labels and their modification, common law duties to warn and their interplay with the FDA’s new guidance. It also suggests certain steps that manufacturers can take to potentially sidestep liability for aftermarket failure to warn.
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The Drug Safety System Conundrum
Author: Thomas N. Tiedt
62 Food and Drug Law Journal 547-558 (2007).
The current turmoil over drug safety is substantially broader in scope and deeper in impact than previous turning points created by new drug laws enacted in response to relatively isolated prescription drug tragedies.
Now, an array of prescription drugs is associated with inadequate safety documentation and surveillance, high-profile market withdrawals, and regular Congressional and media criticism of FDA diligence and corporate behavior regarding the management and mitigation of serious adverse drug reactions. Adverse reactions to prescription drugs have become the most common iatrogenic cause of patient injury and are estimated to elicit more than 700,000 emergency room visits, more than two million hospitalizations and more than 100,000 fatalities in the U.S. annually.
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Pin the Tail on the Other Donkey: Allocating and Avoiding Injury Losses after Drug or Device Approval
Author: James T. O’Reilly
62 Food and Drug Law Journal 559-572 (2007).
Postmarket surveillance is, at heart, a chronicling of what has gone wrong with a therapeutic agent in the “real world” of clinical medicine. Much as we may focus on statistics and predictions, the undeniable reality is that we are accounting for the problems that a new drug or new device may be causing after FDA signs off on its market entry.
This article examines the complex interplay of accounting, statistics, injury and fatality data. Then it looks behind the data gathering to the consequences for patients and their survivors. Death or serious injury to a loved one focuses the mind of the victim’s family on whether it was the therapy or the therapist that caused the harm. Makers of the therapy—device or drug firms—try to pin the liability on the therapist/prescriber; that person “returns the favor.”
The law of medical malpractice remedies was changed by the physicians’ lobby in state legislatures so successfully that the drug/device makers felt the onus of liability suits fall on their shoulders. The producers went to legislatures more recently and begged for a similar exculpation in the form of “tort reform” which shifts the loss onto the patient.
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Medical Device Reporting: Issues with Class III Medical Devices
Authors: Jeffrey Zigler, John Walsh and Jack Zigler
62 Food and Drug Law Journal 573-580 (2007).
Historically, from a clinical aspect, FDA has tended to prompt regulatory change based on a highly publicized single event, such as a major device failure, but has lacked a formal system to collect multiple reports about the same device. These include issues of unpredictability regarding federal preemption of state laws, confidentiality issues implicated in the physician-patient relationship, as well as the potentially harsh consequences of misbranding or adulteration of devices. Additionally, there are several potential legal “impediments” to the FDA’s MDR goals. These include issues of unpredictability regarding federal preemption of state laws, confidentiality issues implicated in the physician-patient relationship, as well as the potentially harsh consequences of misbranding the adulteration of devices.
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Medical Device Recalls from 2004-2006: A Focus on Class I Recalls
Authors: Marta L. Villarraga, Heather L. Guerin and Tac Lam
62 Food and Drug Law Journal 581-592 (2007).
As part of FDA’s Medical Device Postmarket Transformation Initiative, the Center for Devices and Radiological Health (CDRH) is taking steps to increase its ability to identify, analyze and act on postmarket information in order to improve the safety and effectiveness of medical devices.
Over the past few years, the media has focused on a number of medical device recalls leading to even more attention and awareness by the general public. It is evident that medical device recalls have gained more attention from regulatory, manufacturing, engineering, clinical and human factors standpoints.
This paper was undertaken to compile and analyze the publicly available data to make it easier for the reader to get an overview of the content of Class I recalls over a recent three fiscal year period (2004-2006). Recalls were analyzed based on available information, including total number of units recalled, reasons for recalls, or medical device classification.
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Medical Device Safety: FDA’s Postmarket Transformation Initiative
Author: Daniel Schultz
62 Food and Drug Law Journal 593-596 (2007).
FDA’s Center for Devices and Radiological Health (CDRH) is planning significant changes in its postmarket program.
This article describes the anticipated improvements, and how the CDRH’s Postmarket Transformation Initiative will help enable it to rapidly identify safety signals at any point in a product’s lifecycle and take timely action.| Back to top | |
Medical Devices Post-Approval Studies Program: Vision, Strategies, Challenges and Opportunities Authors: Danica Marinac-Dabic, Michele Bonhomme, Nisa Loyo-Berrios, Thomas Gross, Rober Ciperson, Susan Gardner and Michael Marcarelli 62 Food and Drug Law Journal 597-604 (2007). In 2005, oversight of the Center for Devices and Radiological Health new Post-Approval Studies (PAS) Program was transferred to the Office of Surveillance and Biometrics (OSB). |
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Strategy for Surveillance of Adverse Drug Events Author: Roselie A. Bright 62 Food and Drug Law Journal 605-616 (2007). Safety surveillance for marketed drugs currently relies on reporting, inspection, and sampling. Now that electronic health records and data mining software are becoming a reality, it is time for a re-assessment. An ideal surveillance system, based on epidemiologic principles, is proposed that would redress many of the deficiencies of the current system. |
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