Volume 49 Issue 3
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Table of Contents
> Getting a Grip on Material Time and Extent
> Issues Associated with Revision of INAD and
NADA Procedural Regulations
> Agency for Health Care Policy and Research:
Overview of Purpose and Programs
> Keynote Address from the Office of the Director
of CDRH
> An Overview of ISO 9000 Application to Drug,
Medical Device, and Environmental Management Issues
> The Historic Evolution of HACCP: Better Questions,
Safer Foods
> Economics of HACCP for the Seafood Industry
> How Green is my Product and Package:
The Federal
Trade Commission's Environmental Marketing Guidelines
> Patent Extension Under the Drug Price Competition
and Patent Term Restoration Act of 1984
> Legal Overview of FDA Authority Over Imports
Getting a Grip on Material Time and Extent
Author: Kenneth C. Baumgartner
Issue: 49 Food and Drug Law Journal 433-440 (1994)
The issue addressed in this article is newness. The definition of "new drug" in section 201(p) of the Federal Food, Drug, and Cosmetic Act defines the term "new drug" as "[a]ny drug… [which] as a result of investigations…has become so recognized…but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions." This article analyzes the words "material extent or material time" to determine their meaning and importance. Their importance hinges on the fact that a finding of material extent/time is the gateway out of a requirement for a new drug application (NDA) and into the over-the-counter drug review. Regardless of the underlying issues of safety and effectiveness, unless a drug has been marketed to a material extent or for a material time, it is by law a new drug and is subject to the NDA requirements of the Act. As for determining congressional intent for material extent/time, the legislative history in neither the 1938 act nor the 1962 act helps. The concept is mentioned but not defined, and there is no hint as to what Congress intended.
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Issues Associated with Revision of INAD and NADA Procedural Regulations
Author: Jean M. Cooper
Issue: 49 Food and Drug Law Journal 441-448 (1994)
This article discusses the development of regulations governing the review and administrative processing of investigational new animal drugs (INADs) and new animal drug applications (NADAs). It also discusses some of the issues identified by the Food and Drug Administration's Center for Veterinary Medicine (CVM) in considering revisions to the procedural regulations regarding INADs and NADAs. With the exception of some minor revisions, the bulk of those procedural regulations were promulgated in 1975. Over time, CVM has evolved in the areas of its management system, policies, and procedures in efforts use its resources more efficiently. CVM intends to update the INAD and NADA regulations to more clearly communicate its regulatory policies and procedures.
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Agency for Health Care Policy and Research: Overview of Purpose and Programs
Author: J. Jarrett Clinton
Issue: 49 Food and Drug Law Journal 449-462 (1994)
This article describes the purpose and programs of the Agency for Health Care Policy and Research (AHCPR)--one of eight components of the U.S. Public Health Service. The Food and Drug Administration (FDA) is a sister agency to the AHCPR, but unlike the FDA, AHCPR is not a regulatory agency; rather the Agency undertakes or finances research and developmental activities to improve health policy and programs.
AHCPR was created in December 1989 as the federal government's focal point for health services research and more applied health services research programs, such as medical effectiveness and outcomes research. The Agency also facilitates the development and dissemination of science-based clinical practice guidelines and responds to requests from federal health care payors, e.g., the Health Care Financing Administration (HCFA) and the Department of Defense's Civilian Health and Medical Program of the Uniformed Services (CHAMPUS), for assessments of new and established health care technologies.
AHCPR carries out its legislative responsibilities under four broad policy issues: enhancing medical practice, cost of care, quality of care, and primary care and access to services. Each of these will be discussed in this article.
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Keynote Address from the Office of the Director of CDRH
Author: Elizabeth D. Jacobson
Issue: 49 Food and Drug Law Journal 463-468 (1994)
Progress has been made in a number areas in the Food and Drug Administration's (FDA's) medical device program. There is new leadership in the Center for Devices and Radiological Health (CDRH) and new initiatives have been made in the premarket, postmarket, and enforcement programs. Strides were taken to improve communication with industry, such as public workshops on clinical trials, industry-wide letters, and satellite teleconferences. Changes in internal direction have been combined with external outreach to improve CDRH's handling of medical devices. At the same time, new legislative responsibilities have challenged the Center to respond in new directions. The FDA and industry can work together to provide better, safer, and more effective products in a way that meets their needs for predictability and timeliness.
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An Overview of ISO 9000 Application to Drug, Medical Device, and Environmental Management Issue
Author: Anthony L. Young
Issue: 49 Food and Drug Law Journal 485-492 (1994)
This article provides a brief overview of trends in the development of commercial quality standards in general, and in the drug, medical device, and environmental areas in particular, with a focus on Europe, the United Kingdom, and North America. Compliance with such standards increasingly is becoming a competitive necessity to doing business both nationally and internationally. This article focuses on ISO 9000, a widely recognized series of five voluntary quality standards that can be applied to any type of business. In the areas of drugs and medical devices, the article compares the ISO 9000 quality standards with the U.S. Food and Drug Administration's current good manufacturing practices, and discusses potential harmonization of the two. Also discussed is the trend toward expansion of the ISO quality systems concept to environmental management. An ISO environmental standard would provide companies with direction on how to systematically manage, measure, and improve their performance with regard to the environment.
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The Historic Evolution of HACCP: Better Questions, Safer Foods
Author: Theodore C. Cronk
Issue: 49 Food and Drug Law Journal 485-492 (1994)
Hazard Analysis and Critical Control Point (HACCP) originally was developed to ensure that the foods supplied to astronauts during space flights were as free of contaminants as humanly possible. Now, more than thirty years later, HACCP has evolved into a method for ensuring the safety of a wide variety of foods produced on a commercial scale. This article outlines the evolution of HACCP from its beginnings to its current applications, the continuing evolution of the principles which define HACCP, the parallel development of Hazard Analysis and Risk Assessment, and the ongoing international acceptance and refinement of HACCP.
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Economics of HACCP for the Seafood Industry
Author: Lee J. Weddig
Issue: 49 Food and Drug Law Journal 493-498 (1994)
This article examines the economic impact of recently proposed regulations that will require Hazard Analysis Critical Control Point (HACCP) control systems throughout the seafood industry. Cost and benefit analyses of the proposed regulations are impossible to quantify at this time because of the pioneering nature of the proposal. Government preliminary economic impact analysis concentrates on benefits of reduced illnesses and costs of the HACCP systems alone. This article describes other impacts from the effects of HACCP on seafood sourcing and marketability.
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How Green is My Product and Package:
The Federal Trade Commission's Environmental Marketing Guidelines
Author: Kevin M. Bank
Issue: 49 Food and Drug Law Journal 499-510 (1994)
In July 1992, the Federal Trade Commission (FTC) adopted national guidelines for the use of environmental claims in advertising. These guidelines were enacted after the FTC considered petitions to issue guidelines from trade associations, individual companies, and the National Association of Attorneys General. Leading food, cosmetic, and drug trade associations were among those petitioning the FTC to adopt guidelines. The guides indicate how the Commission will apply section 5 of the Federal Trade Commission Act in the area of environmental claims to cover all forms of marketing of products and packages to the public. They address eight specific types of environmental claims. In mid-1995, the FTC will seek public comment on whether and how the guidelines need to be modified. In addition to the guidelines, the Commission has continued to exercise its statutory mandate to prohibit false or misleading environmental advertising claims. Since 1990, twenty-six companies have signed consent agreements settling charges that they made false or unsubstantiated environmental claims about their products.
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Patent Extension Under the Drug Price Competition and Patent Term Restoration Act of 1984
Author: Suzan Kucukarslan and Jacqueline Cole
Issue: 49 Food and Drug Law Journal 511-524 (1994)
The objective of title II of the Drug Price Competition and Patent Term Restoration Act of 1984 was to restore patent life of pharmaceuticals lost during the regulatory review process. This article evaluates almost nine years of experience under that law. The pharmaceutical patent restoration process takes 350 days, including the 180-day public comment period. Due diligence was not a factor in the new chemical entities (NCEs) that were reviewed. The mean extension period was 2.39 years for those patent qualifying for the five-year maximum extension, and one in four NCEs approved did not receive an extension.
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Legal Overview of FDA Authority Over Imports
Author: Paul M. Hyman
Issue: 49 Food and Drug Law Journal 525-532 (1994)
The Food and Drug Administration (FDA) is charged with protecting the health and safety of the U.S. public by ensuring that foods, drugs, cosmetics, and medical devices are safe and properly labeled for their intended uses. Imports of FDA-regulated products continue to increase, as the United States remains the most desirable market for those products. The FDA annually monitors upwards of 1.5 million import entries, representing more than $20 billion worth of products. Thus, imports have become a high priority on the FDA's public health agenda.
Historically, the FDA has been given broad powers to regulate the shipment of foods, drugs, and medical devices in domestic commerce and across the borders of the United States. With the approval of Congress, the FDA holds imported products to the strictest interpretation of the requirements of the Federal Food, Drug, and Cosmetic Act, even though competitive articles already on the U.S. market may fail to meet those standards. There is only limited recourse available in the courts to challenge an unfair or improper exercise of the FDA's authority under the law. Only through an understanding of the law and FDA's policies, and with careful planning, can an importer hope to avoid the legal difficulties inherent in this process.
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