Volume 49 Issue 2
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Table of Contents
> The New European Medicines Agency
> Developments in Canadian Law Relating to Food,
Drugs, Devices, and Cosmetics as of December 1992
> Reporting Adverse Drug and Medical Device Events:
Report of the AMA's Council on Ethical and Judicial Affairs
> The Drug Export Amendments Act of 1986: Is
It All It Was Intended To Be
> Corrective Advertising as a Remedy for the
False Advertising of Prescription Drugs and Other
Professionally-Promoted
Medical Products
> International Expectations for Harmonization
of Biological Standards
> Preemption and Uniform Enforcement of Food
Marketing Regulations
> Nutrition Labeling Initiative
> Optimum Science for Product Review: An Industry
Perspective
> Proposed Changes in Food Safety Legislation
> Electronic Processing of Import Entries
The New European Medicines Agency
Authors: Richard F. Kingham, Peter W.L. Bogaert, and Pamela S. Eddy
Issue: 49 Food and Drug Law Journal 301-322 (1994)
After nearly thirty years of efforts to harmonize national approval procedures for medicines, the European Community (EC) has established the European Medicines Evaluation Agency, a supra-national agency headquartered in London. The Agency will approve product license applications for biotechnology products and certain high-technology products, and will administer a new program for mutual recognition of national approvals for many other medicines. The Agency is scheduled to accept the first applications in January 1995.
The legislation establishing the new approval procedures leaves much room for continued national regulation. Enforcement of requirements concerning such matters as good manufacturing practices, distribution controls, and advertising rules will remain subject to national control. The legislation also leaves some important questions unresolved, including the effect of the new approval procedures on parallel trade between high- and low-price markets, arrangements for market exclusivity, and protection against abridged applications for follow-on products. The new Agency does represent a major step toward further consolidation of the pharmaceuticals market in western Europe.
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Developments in Canadian Law Relating to Food, Drugs, Devices, and Cosmetics as of December 1992Authors: Food and Drug Law Group, Blake, Cassels & Graydon
Issue: 49 Food and Drug Law Journal 323-358 (1994)
Canada is a close and important market for the United States. Although some Canadian laws are similar to those in the United States, many are significantly different. This is no different in the area of food and drug law. This article is a compilation of notes on significant 1992 developments in Canadian food and drug law. It deals with developments in patent, regulatory, advertising, trademark, and competition law in the context of food and drugs. The area is a rapidly changing one in Canada, particularly in patent law relating to pharmaceuticals. This is the first in a series of periodic reviews on legal developments in Canada.
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Reporting Adverse Drug and Medical Device Events:
Report of the AMA's Council on Ethical and Judicial Affairs
Author: American Medical Association
Issue: 49 Food and Drug Law Journal 359-366 (1994)
A physician who suspects the occurrence of an adverse reaction to a drug or medical device has an obligation to communicate that information to the broader medical community (e.g., through submitting a report or letter to a medical journal or informing the manufacturer of the suspect drug or device). Serious adverse events (such as those resulting in death, hospitalization, or medical or surgical intervention) should be reported to the Food and Drug Administration. Spontaneous reports of adverse events are irreplaceable as sources of valuable information about drugs and medical devices, particularly their rare or delayed effects, as well as their safety in vulnerable patient populations. Although premarketing and mandated postmarketing studies provide basic safeguards for the public health, these procedures suffer from inherent deficiencies that limit their ability to detect rare or unexpected consequences of drug and medical device use. Physicians who prescribe and monitor the use of drugs and medical devices constitute the group best able to observe and communicate information about resulting adverse events.
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The Drug Export Amendments Act of 1986: Is It All It Was Intended To Be?
Author: Sheila R. Shulman, Michael Manocchia, and Mark Seibring
Issue: 49 Food and Drug Law Journal 367-384 (1994)
The Drug Export Amendments Act of 1986 authorizes the export of three categories of unapproved drugs and unlicensed biological products. Track 1 (human and animal drugs and biologicals) and Track 3 (partially processed biologicals intended for further manufacture into a final dosage form in the importing country) are eligible for export to twenty-one countries listed in the Act. Track 2 (involving drugs for the treatment of tropical diseases) may be approved for export to any country in which, based on credible scientific evidence, the drug is found to be safe and effective for the prevention or treatment of a tropical disease. This article reviews the legislative history of the Act and its implementation over a five and a half year period (November 1986 to June 1992). Data on export applications submitted and approved were compiled from FDA, industry, and company sources. More than one-third of the approvals under Track 1 involved variations of products previously approved for marketing in the United States; no applications were filed under Track 2 during the study period; and the level of activity under Track 3 fell below expectations. The results of this study raise questions about some aspects of the FDA's interpretation of the legislation.
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Corrective Advertising as a Remedy for the False Advertising of Prescription Drugs and Other Professionally-Promoted Medical Products
Author: Thomas C. Morrison
Issue: 49 Food and Drug Law Journal 385-396 (1994)
Marketers of over-the-counter (OTC) drugs and other health care products have been at the forefront of false advertising litigation under section 43(a) of the Lanham Act. Recently, increased numbers of false advertising lawsuits have involved advertising for prescription drugs and other medical products that are promoted primarily to doctors and health care professionals. In Lanham Act cases involving OTC drugs, the plaintiff's remedy generally has been limited to an injunction prohibiting a continuation of the false claim. In cases involving prescription drugs and medical products marketed to health care professionals, however, many plaintiffs have been successful in obtaining an order that the defendant engage in corrective advertising, such as "Dear Doctor" letters and full-page advertisements in leading medical journals. A series of recent cases illustrates this trend. Inasmuch as advertising directed to doctors and other health care professionals is intended to convey concrete information based on well developed medical and scientific data, the requirement of corrective advertising is a salutary development in Lanham Act jurisprudence.
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International Expectations for Harmonization of Biological Standards
Author: John C. Petricciani
Issue: 49 Food and Drug Law Journal 397-400 (1994)
The system for establishing international biological standards has worked well for many years, with the World Health Organization acting as the primary focus for these activities. Pharmacopeias also serve an important role in providing working standards to the academic community and the pharmaceutical industry. There is a clear need for both types of standards, and it is essential that activities among the various organizations be coordinated and integrated to the greatest extent possible. Scientific and technological advances have caused a blurring of old distinctions between biologicals and drugs. These advances make it less necessary for many new products, such as some manufactured through biotechnology, to be standardized using the bioassay methods that were so important in the past. These advances also could help to make standards harmonization easier, but they raise questions about how biotechnology products should be regulated in the future.
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Preemption and Uniform Enforcement of Food Marketing Regulations
Author: Craig Jordan
Issue: 49 Food and Drug Law Journal 401-408 (1994)
The Nutrition Labeling and Education Act (NLEA) achieves national uniformity for certain specified federal food labeling standards. The NLEA does not impact most traditional state authority, particularly the authority to challenge false or misleading statements in food advertising. The extent to which food marketing regulation is treated uniformly will depend more on the ability of the Food and Drug Administration and the states to work together cooperatively than on the legal requirements of the NLEA.
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Nutrition Labeling Initiative
Author: John McCutcheon
Issue: 49 Food and Drug Law Journal 409-414 (1994)
This article discusses the U.S. Department of Agriculture's (USDA's) nutrition labeling program for meat and poultry products. The USDA made the decision to incorporate the requirements of the Nutrition Labeling and Education Act into its meat and poultry labeling regulations and to closely coordinate its regulations with those of the Food and Drug Administration (FDA), so that the entire food supply would be labeled similarly to better serve the consumer. This article identifies the differences between the USDA and FDA regulations, and provides references to supporting regulations. Where differences exist in the regulatory schemes, they exist due to the nature of the product being regulated. In addition to the nutrition regulations, the differences between USDA and FDA approval systems for labels are explored, as are the changes in its system that are being developed by the USDA.
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Optimum Science for Product Review: An Industry Perspective
Author: James S. Benson
Issue: 49 Food and Drug Law Journal 415-420 (1994)
An issue of growing importance for both the Food and Drug Administration (FDA) and health care product manufacturers is the adequacy of scientific studies to demonstrate safety and effectiveness for new medical devices. This article discusses "optimum science" for product review of those devices. It is the author's contention that there are means to improve the device application process, to reduce the FDA's log jam of applications, and to speed up reviews without sacrificing safety and effectiveness.
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Proposed Changes in Food Safety Legislation
Author: Robert Sussman
Issue: 49 Food and Drug Law Journal 421-424 (1994)
Significant changes lie in the future of the food and drug industry in this country. Protecting the nation's food supply is an important priority of the Clinton administration, and the U.S. Environmental Protection Agency has proposed some changes in food safety reform legislation. Not only will these changes build on the world's most sophisticated and effective food protection system, they will culminate in the reduction of pesticides in the food supply and the ecosystem.
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Electronic Processing of Import Entries
Author: Gary J. Dykstra
Issue: 49 Food and Drug Law Journal 425-431 (1994)
The Deputy Associate Commissioner for Regulatory Affairs provides some commentary and explanatory remarks about the Food and Drug Administration/U.S. Customs Service electronic system for processing import entries. The FDA and the Customs Service have a strong record of working together in this area to achieve an important and difficult objective, namely the successful automation of the import process on a national scale while adhering to the agencies' public health responsibilities for imported products.
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