Volume 61 Issue 1
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Table of Contents
> The Drug Enforcement Administration's Final Rule on Theft and Significant Loss Reporting:We Can See More Clearly Now
by Larry K. Houck , Associate with the law firm of Hyman, Phelps & McNamara, P.C., Washington, D.C. Mr. Houck served in the Drug Enforcement Administration's (DEA's) Office of Diversion Control from 1986 to 2001. He helped enforce the theft/loss reporting regulation while employed with DEA, and has counseled clients on the requirements in private law practice
> The Minor Use and Minor Species Animal Health Act: Past, Present, and Future
by Carol J. Haley, Regulatory Strategist Director at Pfizer Inc., New York, NY. Prior to working for Pfizer, Dr. Haley was Deputy Associate Director of Policy and Regulations at the Food and Drug Administration's Center for Veterinary Medicine.
> The Unfinished Business of U.S. Drug Safety Regulation
by Barbara J. Evans, Director of the Program in Pharmacogenomics, Ethics, and Public Policy, Indiana University Center for Bioethics, Indianapolis, IN
and
David A. Flockhart, Chief of the Division of Clinical Pharmacology, Indiana University School of Medicine, Indianapolis, IN. Dr. Flockhart also is with the Program in Pharmacogenomics, Ethics, and Public Policy, Indiana University Center for Bioethics.
> When Food Is Poison: The History, Consequences, and Limitations of the Food Allergen Labeling
and Consumer Protection Act of 2004
by Laura E. Derr, Associate in the law firm of Covington & Burling, Washington, D.C. This article won First Place in the 2005 H. Thomas Austern Memorial Writing Competition (long papers) sponsored by the Food and Drug Law Institute.
The Drug Enforcement Administration's Final Rule on Theft and Significant Loss Reporting:
We Can See More Clearly Now
Author: Larry K. Houck
61 Food and Drug Law Journal 1-12 (2006).
The Controlled Substances Act (CSA) established a closed distribution system for legal controlled substances to prevent their diversion to illicit use. Drug Enforcement Administration (DEA) regulations require, as one component, that registrants notify the agency of controlled substance theft or significant loss upon discovery, and complete a DEA-106 form. But what constitutes a "significant" loss? What does "upon discovery" mean and when does it occur? How must registrants notify DEA? When must registrants complete a DEA-106? These questions confounded registrants for more than thirty years before DEA issued a final rule amending the regulations in August 2005.
DEA's final rule amends the regulation and provides guidance for registrants. Registrants must notify DEA in writing within one business day of discovery, but can submit the DEA-106 when they know the circumstances of the loss. DEA recognized that discovery can occur over time. The rule also provides factors for registrants to determine whether their loss is "significant." This article analyzes DEA's final rule and what it means for registrants.
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The Minor Use and Minor Species Animal Health Act: Past, Present, and Future
Author: Carol J. Haley
61 Food and Drug Law Journal 13-44 (2006).
In August 2004, President George W. Bush signed the Minor Use and Minor Species Animal Health Act of 2004 (MUMSA) into law. The purpose of this "animal orphan drug act" is to increase the availability of drugs for minor animal species and for rare diseases and conditions in animals. Like the Orphan Drug Act (ODA) of 1983 that has encouraged increased availability of orphan products for humans, MUMSA provides incentives for pharmaceutical companies to pursue the development and approval of products for minor species and rare diseases and conditions in animals. It is likely that MUMSA will have to be amended to ensure that its incentives lead to significantly increased availability of drugs for minor uses and minor species.
This article describes concepts and conditions that led to the development of MUMSA, including its links to the ODA; describes MUMSA's provisions; explains how each provision is intended to improve the availability of drugs for minor species and minor uses; and suggests ways lawmakers and stakeholders can ensure MUMSA fulfills its purpose.
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The Unfinished Business of U.S. Drug Safety Regulation
Authors: Barbara J. Evans & David A. Flockhart
61 Food and Drug Law Journal 45-64 (2006).
Various proposals have been advanced in response to recent problems with the safety of Food and Drug Administration (FDA)-approved drugs. Many call for incremental change, such as new safety oversight bodies or minor expansions of FDA's existing powers. "Fixing" FDA may not fix the problem, without related reform of the broader legal framework in which FDA operates. Key reform challenges include promoting clinical compliance with important safety warnings while preserving needed flexibility for physicians to adapt drug use to the individual patient; developing a clearer distinction between pre- and postapproval safety regulation; and devising mechanisms for funding investments in safety improvements. Until these fundamental problems are addressed, the United States will face ongoing problems with drug safety and patients will be denied the full measure of safety and therapeutic benefit that today's technologies could support. This article proposes a new direction to address these problems in the context of an insurance-based framework for promoting drug safety.
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When Food Is Poison: The History, Consequences, and Limitations of the Food Allergen Labeling
and Consumer Protection Act of 2004
Author: Laura E. Derr
61 Food and Drug Law Journal 65-166 (2006).
This article analyses the history, impact, and limitations of the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA)-the first federal law enacted in the United States aimed directly at helping protect the health and safety of the over thirteen million Americans with certain food sensitivities. The FALCPA establishes a comprehensive scheme for labeling specified food allergens effective January 1, 2006, and implements the most sweeping changes to the food label in America since the Nutrition Labeling and Education Act of 1990. The FALCPA's important benefits are explored, as well as its significant shortfalls.
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