Volume 52 Issue 3
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Table of Contents
> FDA and the 1997 Tobacco Settlement:No Rules
for Twelve Years?
> The Right to a Jury Trial Under the Waxman-Hatch
Act
> The Reformation of Animal Drug Law: The Impact
of 1996
> Extralabel Use and Compounding in Veterinary
Medicine
> Major Issues in Marketing Regulation
> Understanding Government Regulation of the
Marketing and Advertising of Medical Devices, Drugs, and Biologics:The
Challenges of the Internet
> The Progress of Global Harmonization and
Mutual Recognition Efforts for Medical Devices
> Are Functional Foods the Solution to Dysfunctional
Diets? A Review of U.S. Regulatory Requirements and Lessons
From Abroad
> Update on Implementation of the Final Rule
on Pathogen Reduction and HACCP
> Status of Seafood HACCP
> Delivering on HACCP’s Promise to Improve
Food Safety: A Comparison of Three HACCP Regulations
> The Truth and Consequences of “Standards
of Identity”
> Quality Control and Good Manufacturing Practices:
Safety and Efficacy of Commercial Herbals
FDA and the 1997 Tobacco Settlement: No Rules for Twelve Years?
Author: James T. O'Reilly
Issue: 52 Food and Drug Law Journal 253 (1997)
The Food and Drug Administration's (FDA's) safety protection role would be shackled by congressional adoption of one aspect in the June 1997 Tobacco Settlement. This article acknowledges that creation of the settlement by state attorneys general was a major accomplishment, but a small "sleeper" provision prevents FDA from effectively regulating any content of tobacco products until the year 2011. If Congress adopts this provision, the article concludes, FDA's medical device regulators will be unable to act for a dozen years, even in the face of any new data about harmful contaminants or components of cigarettes. Formal rulemaking and a set of impossible conditions make the Settlement clause unworkable, unprecedented, and unusually bad public policy.
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The Right to a Jury Trial in Actions Under the Waxman-Hatch Act
Authors: Brian D. Coggio and Sandra A. Bresnick
Issue: 52 Food and Drug Law Journal 259 (1997)
The Waxman-Hatch Act created a new and artificial action for patent infringement based on the filing of an abbreviated new drug application (ANDA) (itself created by the Act) seeking Food and Drug Administration approval to market a pharmaceutical product before expiration of the relevant patents. This action and the exclusive remedies for such infringement are codified in 35 U.S.C. sections 271(e)(2) and 271(e)(4), respectively. The authors of the article conclude that neither the statute nor the Seventh Amendment requires a jury trial in these ANDA-based infringement actions because the nature of the action and the available remedies are equitable, not legal. In reaching this conclusion, the effect of declaratory judgment claims and counterclaims for invalidity or noninfringement are considered.
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The Reformation of Animal Drug Law: The Impact of 1996
Author: Eugene I. Lambert
Issue: 52 Food and Drug Law Journal 277 (1997)
Animal drug law started in 1968, when the strands of new drug, antibiotic, and food additive regulation were braided together into a single regulatory system for new animal drugs and feeds containing new animal drugs. That process was imperfect, as it did not focus on the unique character of animal drug uses. Initial steps in recognizing the different character of animal drug regulation were taken in 1988, with the passage of the Generic Animal Drug and Patent Term Restoration Act, and in 1994, with the adoption of the Animal Medicinal Drug Use Clarification Act. Two 1996 enactments further recognized the separate regulatory needs of the animal drug industry. In the FDA Export Reform and Enhancement Act, animal drugs were freed from the export restraints of the human drug industry. The Animal Drug Availability Act made a number of additional advances by:
- changing the criteria for proof of efficacy, to provide more flexibility in study requirements;
- simplifying the requirements for many combination drug approvals;
- providing a process for greater certainty in designing drug studies;
- creating a new class of feed drugs limited to use under a veterinarian's "directive";
- providing for tolerances to be adopted for residues in imported food products of drugs unapproved in the United States; and
- changing the regulation of medicated feeds from product to establishment licenses.
These changes start to focus regulation on animal drugs as a system independent of the regulation of human drugs.
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Extralabel Use and Compounding in Veterinary Medicine
Author: Richard E. Geyer
Issue: 52 Food and Drug Law Journal 291 (1997)
The Animal Medicinal Drug Use Clarification Act (AMDUCA) legitimizes extralabel use in animals of approved animal and human drugs, when that use is under the supervision of a veterinarian and in accordance with FDA regulations. This article summarizes the major provisions of AMDUCA and FDA's implementing regulations, which were effective in December 1996. The article also discusses FDA's requirements for compounding drugs for animal use from both approved and unapproved drugs.
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Major Issues in Marketing Regulation
Author: Wayne L. Pines
Issue: 52 Food and Drug Law Journal 297 (1997)
FDA has made progress recently in developing new policies for the regulation of advertising and promotion and in revising existing ones, but other issues remain that merit attention. Former Food and Drug Administration (FDA) Commissioner David A. Kessler initiated increased regulation in this area, and FDA plans to continue its aggressive regulation of advertising and promotion. The pharmaceutical, biologics, and medical device industries each have faced different issues in this area, but there are issues that universally affect how these industries can successfully market their products and remain within FDA's guidelines. As FDA continues to address its regulation of promotional activities, topics such as the "brief summary" requirement and consistent enforcement among the agency Centers must be given attention.
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Understanding Government Regulation of the Marketing and Advertising of Medical Devices, Drugs, and Biologics: The Challenges of the Internet
Author: Peter S. Reichertz
Issue: 52 Food and Drug Law Journal 303 (1997)
At the end of June 1997, the Food and Drug Administration (FDA) had yet to issue any formal or informal guidance on promotion of prescription drugs and medical devices on the Internet. In this vacuum, regulated industry has faced the challenge of attempting to apply FDA's current regulations and policies to this new form of electronic communication. This article addresses the challenges of the regulated industry and what type of enforcement FDA has undertaken against promotion on the Internet. It also discusses what FDA's current thinking is on Internet promotion and the items likely to be addressed when FDA issues guidance on the subject.
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The Progress of Global Harmonization and Mutual Recognition Efforts for Medical Devices
Author: William W. George
Issue: 52 Food and Drug Law Journal 309(1997)
With the imminent appointment of a new Food and Drug Administration (FDA) Commissioner, as the European Community (EC) expands its reach, and as the rapidly developing nations of Asia and the Mediterranean attempt to establish regulatory systems for medical devices, the time is right to put a process in place that will lead to the establishment of a common international regulatory system for medical devices. The United States, member nations of the EC, Canada, Australia, and Japan could be the initial signatories for such a system, and emerging medical device countries like Israel, China, Korea, India, and South Africa could join. This article describes how this system might work and notes that the current global harmonization and mutual recognition efforts can evolve into such a system. Reaching agreement will require a considerable amount of effort by FDA, the EU, and others, along with the willingness to establish superordinate goals that transcend national interests. The benefits of realizing such a concord, however, are so great that they are well worth the time, energy, and flexibility required.
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Are Functional Foods the Solution to Dysfunctional Diets?
A Review of U.S. Regulatory Requirements and Lessons from Abroad
Authors: Bruce A. Silverglade and Ilene Ringel Heller
Issue: 52 Food and Drug Law Journal 313 (1997)
Functional foods are receiving increased attention as food manufacturers seek to appeal to consumers with foods that emphasize the positive nutritional attributes of new added ingredients. This article will focus on two seemingly contradictory propositions:
- functional foods do not exist, and
- practically all foods are functional foods.
The article will begin with a discussion of the first point — that functional foods do not exist — but will then discuss how such foods theoretically could be regulated in the United States. It will then review the functional food experience in the United Kingdom, Japan, and China, where such products are widely sold. Finally, the article concludes with a discussion of the second proposition, that practically all foods are functional foods.
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Update on Implementation of the Final Rule on Pathogen Reduction and HACCP
Author: Margaret Glavin
Issue: 52 Food and Drug Law Journal 323 (1997)
The Food Safety and Inspection Service (FSIS) is heavily involved in implementation of the final rule on pathogen reduction and Hazard Analysis and Critical Control Point (HACCP) systems. Implementation began on January 27, 1997, and will be completed by January 25, 2000. Training of FSIS employees is ongoing, and FSIS has provided assistance to industry to help implement the new rules. FSIS will issue technical amendments to the final rule to clarify a number of questions, and is proceeding with a reorganization to better prepare the agency to operate under a HACCP-based system.
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Status of Seafood HACCP
Author: Philip C. Spiller
Issue: 52 Food and Drug Law Journal 327 (1997)
The Food and Drug Administration's (FDA's) Hazard Analysis Critical Control Point (HACCP) regulations were published in December 1995 with an effective date of December 1997. This article reviews the steps that FDA has taken to ensure that the implementation of this important new program is successful. These steps include technical assistance to industry in the form of training programs and a hazards and controls guide for seafood, as well as training for regulators on federal and state levels regarding the audit of HACCP systems. FDA also is considering a system for recording and making public the precedents that are established through case-by-case determinations on the adequacy of HACCP systems in various situations.
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Delivering on HACCP's Promise to Improve Food Safety: A Comparison of Three HACCP Regulations
Author: Caroline Smith DeWaal
Issue: 52 Food and Drug Law Journal 331 (1997)
The two major agencies in the federal government responsible for ensuring the safety of the food supply have started adopting a system of industry-designed preventive controls called Hazard Analysis and Critical Control Points (HACCP). Previously, the only regulatory use of HACCP was for low-acid canned foods. In January 1994 the Food and Drug Administration (FDA) announced plans to implement mandatory HACCP systems for the seafood industry, followed several months later by proposed HACCP rulemaking for all sections of the food industry. In early 1995, the U.S. Department of Agriculture (USDA) announced plans to implement mandatory HACCP for the meat and poultry industries. In total, three versions of HACCP have been adopted by federal regulation. The two versions of HACCP adopted by FDA are strikingly different; the version that covers low-acid canned foods is highly prescriptive and has worked very well, while the seafood version is highly permissive but has yet to be implemented and demonstrated effective. USDA's HACCP program for meat and poultry is the first to grapple with the issues of accountability, while leaving the responsibility for designing the systems to the industries.
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The Truth and Consequences of "Standards of Identity"
Author: Joseph M. Pocius
Issue: 52 Food and Drug Law Journal 337 (1997)
Standards of identity for poultry and meat products traditionally have been tools used by industry to police itself. They were created by industry, and enforced by government, to keep substandard quality products from entering the marketplace and undermining the position of higher-quality products. Today, standards are perceived by some individuals to be consumer protection measures. Some product standards must be maintained for purposes of domestic commodity trading and overseas exports; less clear is whether standards of composition for formulated products are necessary. Processing and ingredient-use flexibility may be allowed while maintaining food safety levels and providing products that meet current nutritional demands. Consumers vote with their dollars. Given full ingredient label disclosure, consumers will "vote" for products through purchases. Products not meeting consumer expectations will be dropped from the marketplace. Moving away from strict adherence to standards, using wider varieties of ingredients, and allowing for processing flexibility to reach food safety targets will promote the development of products that more readily meet society's demands.
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Quality Control and Good Manufacturing Practices: Safety and Efficacy of Commercial Herbals
Author: Dennis V.C. Awang
Issue: 52 Food and Drug Law Journal 341 (1997)
The need for better regulatory control of commercial botanical raw material and herbal products is reflected in the variety of undertakings to produce monographs for the most prominent plants reputed to possess medicinal properties. Apart from addressing methods for the establishment of botanical identity by physical means (microscopic as well as macroscopic), monographs describe the latest and most convenient tests for chemical identification through characteristic markers, as well as the detection of natural variation by spectroscopic examination and chemical profiling. Assay procedures for distinctive marker compounds and/or recognized active constituents often are included. Comprehensive monographs record traditional medicinal use and summarize scientific data in support of modern therapeutic claims. The most fundamental deficiency of the regulatory approach, particularly in North America, is a lack of organized programs to ensure the proper identity and quality of marketed plant products. Adherence to a program such as that embodied in the World Health Organization's Guidelines for the Assessment of Herbal Medicines and its Quality Control Methods for Medicinal Plant Materials would seem a logical antecedent and a valuable complement to sound scientific plant monographs. An efficient scheme is needed for certification of botanical identity and effective implementation of good manufacturing practices (GMPs), along with a program of regular analytical surveys of commercial herbal products.
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