Volume 48 Issue 4
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Table of Contents
> The Agency for Health Care Policy and Research
and the Pharmaceutical Industry
>The Orphan Drug Regulations and Related Issues
> Developing Drugs for Tropical Diseases Rare
in the United States:
A Case Study on African Sleeping Sickness
> Current Developments in Implementing the Generic
Drug Enforcement Act
> Over-the-Counter Drug Authority Issues: Selected
Topics
> The FDA's New Over-the-Counter Drug Office
and Advisory Committee: An Industry Perspective
> Prescription to Over-the-Counter Drug Switches
> Supplementary Protection Certificates in the
European Economic Community
> Europe's Centralized New Drug Procedures: Is
the United States Prepared to Keep Pace?
> Discord and Change: An Assessment of the European
Community's Food Packaging Laws
> The NLEA, Health Claims, and the First Amendment
> Nutrient Descriptor and Disease Claims for
Foods Under the New FDA and USDA Rules
> Temporary Marketing Permits: The Hidden Regulation
in Market Testing
> Directions in Device Regulation: Past, Present,
and Future
> Enforcement Overview
> How Should FDA Regulation of Medical Devices
Change?
The Agency for Health Care Policy and Research
and the Pharmaceutical Industry
Author: Robert T. Angarola and Brian L. Pendleton
Issue: 48, Food and Drug Law Journal 511-524 (1993)
The Agency for Health Care Policy and Research (AHCPR), established in 1989, has begun to significantly impact health care in the United States, including the manufacture of pharmaceuticals. Congress set up AHCPR under the 1988 Budget Act to develop clinical practice guidelines to help physicians and other health care practitioners prevent, diagnose, and treat diseases and conditions in the most effective and appropriate manner. AHCPR also provides funding for studies on a wide variety of medical issues, and conducts research on the outcomes and effectiveness of health care services and procedures. Because these AHCPR programs often address the usefulness of particular drug therapies, they can have a profound effect on pharmaceutical manufacturers. Therefore, manufacturers should participate in AHCPR programs wherever possible, e.g., by having employees serve on patient outcomes research groups and offering comments on proposed clinical practice guidelines that involve drug treatment. Drug companies also should keep informed about AHCPR activities, urge their researchers to publish their findings so they will be available to agency reviewers, and assist in the dissemination of AHCPR materials.
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The Orphan Drug Regulations and Related Issues
Author: Joseph A. Levitt and John V. Kelsey
Issue: 48 Food and Drug Law Journal 525-532 (1993)
The Orphan Drug Act, enacted in 1983, has been successful in bringing products for rare diseases to market. This law also has been the source of some controversy--the Act has been amended three times and after a lengthy development period, the implementing regulations for this law were published in January 1992. This article reviews Food and Drug Administration activities aimed at promoting the development of products for rare diseases under the Orphan Drug Act and then discusses the agency's implementing regulations. Ongoing efforts to amend the Act also will be summarized.
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Developing Drugs for Tropical Diseases Rare in the United States:
A Case Study on African Sleeping Sickness
Author: Nathan J. Treinish
Issue: 48 Food and Drug Law Journal 533-536 (1993)
This article discusses developing orphan drugs for tropical diseases that are rare in the United States through a case study on Ornidyl (eflornithine hydrochloride), a drug which is used to treat African Sleeping Sickness. The article reviews the history of the development of the drug, which began prior to enactment of the Orphan Drug Act, and how the drug qualified for orphan drug status. The Orphan Drug Act probably facilitated approval of the product in the United States. This case study represents an example of the public policy reflected in the legislative history to encourage development of drugs prevalent in developing countries.
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Current Developments in Implementing the Generic Drug Enforcement Act
Author: Douglas I. Ellsworth
Issue: 48 Food and Drug Law Journal 537-544 (1993)
In 1992, Congress passed the Generic Drug Enforcement Act in response to the discovery of fraud and corruption in a segment of the generic drug industry. This new law authorizes the Food and Drug Administration (FDA), on the basis of certain types of corrupt conduct; to debar individuals and firms; to impose fines; and to suspend distribution, temporarily deny approval, or withdraw approval of drugs covered by abbreviated human drug applications. Currently, the FDA is exercising its mandatory debarment authority for individuals and is developing standards for permissive and mandatory debarment of firms and the permissive debarment of individuals. The Act also provides for termination of debarment under special circumstances and the FDA is developing standards for taking such actions.
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Over-the-Counter Drug Authority Issues: Selected Topics
Author: Linda R. Horton
Issue: 48 Food and Drug Law Journal 545-562 (1993)
The Food and Drug Administration (FDA) has two well-developed and fairly effective regulatory systems for over-the-counter (OTC) drugs: the OTC monograph system and the new drug application system for those OTC drugs that are new drugs. Under either system, production must be in accord with current good manufacturing practices as well as general ground rules on registration and labeling. Despite the "relative efficacy" of both of these systems, difficult compliance issues involving OTC drugs persist, due mostly to efforts to market products without following the rules of either the monograph or the new drug approval system. This article first discusses definitional issues and the FDA's efforts to deal with them. Next, the article covers the mechanisms for the FDA to obtain information it needs to operate as an informed regulatory body, including inspection authority and other tools. Finally, the article discusses the current and proposed remedies available to the FDA to deal with violations.
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The FDA's New Over-the-Counter Drug Office and Advisory Committee: An Industry Perspective
Author: Eve E. Bachrach
Issue: 48 Food and Drug Law Journal 563-566 (1993)
The Food and Drug Administration's (FDA's) establishment in 1991 of the Office of Over-the-Counter (OTC) Drug Evaluation and the Nonprescription Drugs Advisory Committee expanded the resources available for the agency to regulate OTC drugs efficiently and well. Adherence by the Advisory Committee and the agency to the principles of openness, fairness, participation, and independent scientific judgment will help to ensure the best scientific and regulatory decisionmaking. The Office and the Advisory Committee can make their greatest contributions in prescription-to-nonprescription drug switch, exertion of strong federal leadership to forestall rival state requirements, completion of the OTC Review and maintenance of a dynamic monograph system, and maintenance of the distinction between old and new drug decisionmaking. The Advisory Committee serves as a scientific resource and advisor to the agency, which in turn is responsible for decisionmaking. The Advisory Committee also must be kept well-informed about the fundamental difference between prescription drugs, which involve a doctor's intervention, and OTC drugs, with which consumers are engaged actively in self-care.
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Prescription to Over-the-Counter Drug Switches
Author: Linda M. Katz
Issue: 48 Food and Drug Law Journal 567-570 (1993)
Drugs switched from prescription to over-the-counter (OTC) status are assessed differently throughout the review divisions of the Food and Drug Administration. This article presents the approach used by the Pilot Drug Evaluation Staff. Three types of switches--complete, partial, and lower effective dose (the latter being not a true switch situation)--are described, in addition to the approaches taken to assess safety and efficacy of these drugs. The concept of usage trials and their place in the switch process also is discussed. Switch considerations require a weight-of-the-evidence, case-by-case approach, based on prior knowledge gained from marketing experience with the drug, specifically with regard to safety and efficacy.
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Supplementary Protection Certificates in the European Economic Community
Author: Edward H. Mazer
Issue: 48 Food and Drug Law Journal 571-576 (1993)
The European Community (EC) recently enacted legislation which enables patent holders to secure an extended term of market exclusivity after patent expiration for pharmaceutical compounds, formulations, and processes for manufacture which require regulatory approval. Eligibility for the Supplementary Protection Certificate (SPC) may vary from country to country within the EC. The SPC legislation provides that the maximum term of market exclusivity is fifteen years from the first EC health registration approval, but not more than five years after the expiration of the patent. Individual SPC applications must be filed in each EC member country by the patent holder within six months of the date when a patent and health registration both have been granted in that country for the product. Non-EC countries which are members of the European Free Trade Alliance are in the process of enacting similar legislation.
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Europe's Centralized New Drug Procedures: Is the United States Prepared to Keep Pace?
Author: Eric M. Katz
Issue: 48 Food and Drug Law Journal 577-588 (1993)
The European Parliament has given final approval to a new European Agency for the Evaluation of Medicinal Products. The prospect of a single approval procedure for twelve (or more) European countries will have ripple effects on new drug development worldwide. Because the largest single market will no longer be the United States but rather the European Union, the drug development procedures of the U.S. Food and Drug Administration (FDA) may lose some of the economic clout they formerly enjoyed. To remain at the forefront of worldwide drug development efforts, the FDA may need to increase efforts at international harmonization and adopt elements of the European system that drug sponsors may find particularly attractive. If drug sponsors come to perceive the European system as providing an easier or more predictable path to a larger and more lucrative market, drug sponsors might initially reject the U.S. market, consequently delaying Americans' ability to enjoy the health benefits of the latest therapeutic products. Accordingly, keeping pace with cutting-edge regulatory standards is not merely a matter of scientific pride for the FDA, but a question of public health for the United States as well.
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Discord and Change: An Assessment of the European Community's Food Packaging Laws
Author: Charles Lister
Issue: 48 Food and Drug Law Journal 589-630 (1993)
The European Community is in the midst of an important second cycle of legislation regarding food packaging. A new framework of general regulatory principles has been adopted, as well as new and revised requirements for plastic products and regenerated cellulose film. In addition, the Community's existing rules encompass such matters as packaging materials, constituent migration, and packaging sizes and shapes. Proposed legislation would supplement many of these rules, and also would add new requirements regarding such important matters as packaging waste. The Community's existing and proposed rules differ in many significant respects from requirements in the United States, although each of their interests would be better served if their rules were at least broadly similar. This article describes the Community's policies and rules regarding food packaging, and evaluates the directions in which those policies are now moving.
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The NLEA, Health Claims, and the First Amendment
Authors: Edward Dunkelberger and Sarah E. Taylor
Issue: 48 Food and Drug Law Journal 631-664 (1993)
This article examines the regulation of health claims by the Food and Drug Administration (FDA) under the Nutrition Labeling and Education Act of 1990 (NLEA) in view of First Amendment limitations on the regulation of commercial speech. The article critiques specifically the constitutional arguments offered by the agency in the preamble to the final regulations on health claims. The most severe restriction on free speech imposed by the regulatory scheme is the prohibition of health claims that are unapproved by the FDA, including those that are truthful, nonmisleading, and fully substantiated. The article argues that the ban of such unapproved claims violates constitutional requirements and undermines the public health objectives of the NLEA by chilling health claims and depriving the public of useful health information. The Supreme Court has rejected prophylactic regulatory schemes like the NLEA regulations as unconstitutional and has embraced instead policies similar to that of the Federal Trade Commission governing advertising claims. These decisions suggest that health claims in labeling should be regulated in a manner similar to current regulations of advertising claims and that any effort to harmonize requirements for health claims in labeling and advertising should be accomplished principally by reforming labeling requirements.
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Nutrient Descriptor and Disease Claims for Foods Under the New FDA and USDA Rules
Author: Elizabeth Toni Guarino
Issue: 48 Food and Drug Law Journal 665-674 (1993)
This article provides food manufacturers with a summary of the new Food and Drug Administration and U.S. Department of Agriculture rules for nutrient descriptor and disease claims made on food labels and in food labeling. The Nutrition Labeling and Education Act of 1990 established new, strict preclearance requirements for these types of claims, which are of great interest to the food industry because of the recent explosion in scientific evidence about the relationships between certain nutrients and good health. The new rules encompass "absolute" claims (e.g., "low fat," "high fiber") and "comparative" claims (e.g., "reduced sodium," "more fiber," "light") concerning nutrients, and claims about the relationships between nutrients and the risk of diet-related diseases (e.g., the relationship between calcium and osteoporosis). From the perspective of the food industry, the final rules are an improvement over the proposed versions, although only time will tell whether the rules have the intended effect of encouraging product innovation.
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Temporary Marketing Permits: The Hidden Regulation in Market Testing
Author: Traci S. Takaki
Issue: 48 Food and Drug Law Journal 675-696 (1993)
This article examines the Food and Drug Administration's (FDA's) selective enforcement of a policy which requires new foods intended as substitutes for standardized foods to obtain temporary marketing permits (TMPs) or face misbranding charges. First, the history and development of food standards, and the FDA's enforcement thereof, are reviewed. Then the development of the FDA's policy of using TMPs to regulate the introduction of new foods is discussed. Finally, potential solutions to the problem are presented, including modifying the regulations to adequately and fairly address substitutes for both standardized and nonstandardized foods, and challenging the FDA's policy on procedural grounds.
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Directions in Device Regulation: Past, Present, and Future
Author: Jane E. Henney
Issue: 48 Food and Drug Law Journal 697-702 (1993)
This article focuses on the Center for Devices and Radiological Health's (CRDH's) management action plan, and the initiatives being undertaken in premarket and postmarket settings. Also discussed are new appointments to leadership positions within the Center and critical resource issues that will impact the Center's ability to accomplish its mandate. The management action plan calls for sharing resources and expertise and reaffirming CDRH's commitment to high standards in review, research, and enforcement activities. The premarket objectives of this plan include adding resources and expertise to the review process, clarifying the rules for product approval and giving manufacturers time to comply, improving internal management procedures to make the review process more effective and efficient, and improving communications with manufacturers. In the postmarket surveillance area, the newly created Office of Surveillance and Biometrics will streamline the Center's programs related to adverse experience reports and will elevate the visibility of postmarket management programs within CDRH.
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Enforcement Overview
Author: Ronald M. Johnson
Issue: 48 Food and Drug Law Journal 703-708 (1993)
For the Food and Drug Administration's (FDA's) Center for Devices and Radiological Health (CDRH), much has changed over the past year or so. Industry-wide anxieties that developed due to threats of aggressive and stepped-up enforcement have lost ground to real concerns as product review times have increased exponentially. With a dimmed spotlight on enforcement, CDRH has had a brief respite to assess where the Center has been and where it should go. This article reviews and analyzes the changes CDRH has implemented and actions it has taken over the last year.
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How Should FDA Regulation of Medical Devices Change?
Author: David M. Steinhaus
Issue: 48 Food and Drug Law Journal 709-712 (1993)
The Food and Drug Administration (FDA) has the legitimate and important function of ensuring the safety and efficacy of medical devices. Physicians need to be secure in the knowledge that available technology has been subjected to scientific scrutiny and fairly tested. However, in the recent past, bureaucracy and post-delays in the approval process have become excessive, denying patients the availability of what may be life-saving devices. Because of the regulatory environment, industry also has begun manufacturing and conducting clinical trials in foreign countries where the process is less cumbersome. This practice may threaten the United States' preeminence in medical research. The FDA must become more "user friendly." A way must be found to ensure rigorous scientific proof of safety and efficacy, yet remove the paperwork and regulatory delays. A better working relationship needs to be forged between industry and physicians. Improved postmarket release surveillance would allow earlier patient access to new technology, yet alleviate safety concerns. Finally, the public must understand that no devices are ever perfect and risk-free.
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