Volume 50 Issue 4
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Table of Contents
> Medical Technology and Competitiveness in
the World Market: Reinventing the Environment for Innovation
> The Mammography Quality Standards Act of
1992: History and Process
> Challenges in Human Subject Protection
> The Food and Drug Administration’s Early
Access and Fast-Track Approval Initiatives:
How Have They
Worked?
> Stoning a Dead Bird: Advertising Limits on
Approved New Drugs
> Consumer-Directed Advertising of Contraceptive
Drugs: The FDA, Depo-Provera, and Products Liability
> How Do We Maintain U.S. Global Food Edge?
> New Packaging Technologies
Medical Technology and Competitiveness in the World Market:
Reinventing the Environment for Innovation
Author: William W. George
Issue: 50 Food and Drug Law Journal 477-484 (1995)
Medical device manufacturers in the United States face myriad challenges, including competing in the world market and developing innovative technologies in a highly regulated environment. This article calls for effective and timely solutions to some of the problems faced by device manufacturers: the cumbersome approval process, unnecessary restrictions on export of innovative medical technology, reimbursement practices that discourage participation in clinical trials, and a product liability system that has contributed to major materials shortages in the industry. The article advocates an avenue for change such that the U.S. government ensures a regulatory climate that rewards innovative manufacturers who develop safe and cost-effective new products; while medical technology is advancing at the most rapid pace in history, an equally advanced approval process is warranted.
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Authors: Florence Houn, Kathleen A. Franks, Maria L. Elliott, Charles A. Finder,
Roger L. Burkhart, and Ruth Fischer
Issue: 50 Food and Drug Law Journal 349-355 (1995)
Congress passed the Mammography Quality Standards Act of 1992 (MQSA) to provide the nation with baseline quality standards for the performance of mammography. The food and Drug Administration (FDA) received authority from the Secretary of Health and Human Services to implement the Act in June 1993. The regulation of mammography was framed into a set of statutory requirements of quality standards, accreditation, certification, annual inspections, and sanctions. Involving multiple overlapping areas of oversight and private-state-federal relations, the MQSA program strives to ensure that all mammography facilities in the United States meet quality standards to maximize the efficacy of mammography in the early detection of breast cancer through the FDA’s development and implementation of both accreditation and certification programs.
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Author: Stuart L. Nightingale
Issue: 50 Food and Drug Law Journal 493-501 (1995)
This article provides a brief overview of the Food and Drug Administration’s (FDA’s) human subject protection regulations—those that govern the functioning of institutional review boards (IRBs) and informed consent requirements—as prelude to presenting current challenges to the FDA and the community charged with human subject protection. Specific challenges include legal, regulatory, and ethical challenges. The article describes some of these and explains how the agency is approaching them. Topics include: informed consent and emergency research, use of placebo controls in certain studies, and the current relevance of certain documents the have been the ethical touchstone for the protection of human subjects of research for many decades. The article also describes so-called “comprehension challenges,” which have to do with understanding some of the regulatory and statutory requirements under which the FDA functions. An example of this is the difference between significant and nonsignificant risk devices. Other examples include understanding the differences between Department of Health and Human Services and the FDA regulatory requirements in human subject protection, as well as issues pertaining to women in clinical trials. Finally, the article describes the FDA’s major guidance for the IRB and clinical investigatory community — its Information Sheets, which have undergone extensive revision and recently have been published.
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How Have They Worked?
Authors: Sheila R. Shulman and Jeffrey S. Brown
Issue: 50 Food and Drug Law Journal 385-388 (1995)
This article assesses the implementation of the Food and Drug Administration’s (FDA’s) four initiatives that target drugs intended to treat life-threatening and seriously-debilitating illnesses. The treatment IND regulations and the parallel track policy provide options for the distribution of “promising investigational drugs” outside of, but concurrent with, ongoing clinical trials; the Subpart E and the accelerated approval regulations incorporate measures to speed FDA approval by compressing clinical development and agency review times. The regulatory structure of each initiative is reviewed. Implementation is documented through December 31, 1994, including descriptive data on the specific drugs designated for each program. These include thirty-three treatment INDs and one formal parallel track protocol, as well as twenty-eight Subpart E and eight accelerated approvals. To offer some perspective on the impact of the regulatory schemes, data are presented concerning the length of the “early access period” (time from designation to FDA marketing approval) for treatment IND and parallel track drugs, and on the clinical, FDA review, and total regulatory phases for all affected compounds. The data provide the basis for an initial assessment of the impact of these programs. The results indicate some of the difficulties in permitting access to important new compounds at increasingly early points in the development process where important evidence concerning risk/benefit determinations has yet to be confirmed. The data do suggest, however, that elements of the Subpart E regulations in particular may hold promise for substantially reducing the clinical development period and shortening the time required for FDA review. Consideration should be given to broadening the application of Subpart E procedures to other categories of diseases and drugs.
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Author: Jur Strobos
Issue: 50 Food and Drug Law Journal533-551 (1995)
The Food and Drug Administration’s (FDA’s) policy on advertising limits the dissemination of information about innovations in patient care. The FDA has provided four rationales to support this proscription: 1) it maintains the standard of evidence for efficacy; 2) it prevents ill-advised unapproved uses; 3) it creates an economic incentive to file supplements; and 4) it is a level playing field. These explanations are not well-founded because of the existence of an “underground” market in any information about drugs. Without a clear distinction in clinicians’ minds between labeled and underground information, the standard for efficacy is eroded. Ill-advised unapproved uses are common because such a distinction has not been made. The incentive to file supplements is eroded by the existence of the underground market. If the FDA were to change its policy, by legalizing but regulating the information that now finds its way into the underground system, the agency might achieve its broader goals. Clinicians and patients would be better served. This article proposes a system of appropriate regulation of off-label information dissemination by sponsors.
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Issue: 50 Food and Drug Law Journal 553-567 (1995)
Pharmaceutical manufacturers have advertised prescription drug products directly to the public for over a decade. Since the Food and Drug Administration (FDA) approved Depo-Provera, a three-month injectable contraceptive, in 1992, Upjohn, its manufacturer, has advertised the drug to the public. The Depo-Provera advertisement provides the opportunity to explore consumer-directed prescription drug advertising in terms of the dual federal and state risk regulation system, which governs the public availability and individual use of prescription drugs. Part II analyzes the advertisement and its compliance with section 502(n) of the Federal Food, Drug, and Cosmetic Act. Part III explores the state product liability consequences of the advertisement’s failure to sufficiently disclose one major short-term side effect—heavy and prolonged menstrual bleeding. The article discusses a hypothetical case and two defenses that Upjohn likely would raise—the learned intermediary rule and the federal constitutional doctrine of preemption. It suggests that courts would be likely to reject these defenses, thereby exposing the company to liability for its failure to warn. In sum, this study casts doubt on the argument that state product liability law does not have a prominent risk regulation role, and suggests that the current dual system of risk regulation provides a comprehensive approach to risk reduction.
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Author: Al S. Clausi
Issue: 50 Food and Drug Law Journal399-413 (1995)
The U.S. food industry is undergoing some dramatic changes as it moves from being primarily a U.S.-oriented industry to becoming a global competitor. In this new era, there are no “haves” and “have-nots” in food technology. U.S. dominance in food science is over, and the U.S. food industry should recognize that reality and work it to its advantage. This industry must transfer its technology to all of its global markets and learn how to utilize that which resides off-shore. The industry also must advance its competitive intelligence and develop managers who have a global market perspective. While many nations have cooperative food science consortia between industry, government, and academia, the United States has a paucity of such institutions. The U.S. food industry must learn how to cooperate in food science with the other sectors, or run the risk of losing its already-shrinking competitive advantage in world food trade.
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Author: Robert F. Testin
Issue: 50 Food and Drug Law Journal 575-579 (1995)
This article notes that food packaging developments continue to increase at a rapid, exponential pace. The general public, however, is mostly unaware of these changes and often accepts new packaging concepts as if they had always been in the marketplace. It is suggested that the primary drivers of change in food packaging will be health concerns, taste (of foods), and time. Three probable food retaining methods of the future—small specialty shops, fully automated food stores, and ordering by computer—will require vastly different packaging technologies. Emerging packaging technologies that are discussed include continued expansion of modified atmosphere packaging (MAP), the need for methods to alert consumers when MAP food products have been temperature abused, a trend toward greater use of flexible food packaging, and increased use of specialized packaging/machinery combinations. Edible film technology, packages that self-heat and cool, new printing technologies, and holographic imaging are also discussed. The article closes with thirteen predictions on the future of food packaging technology.
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