Contraceptive Research and Development Looking to the Future (1996) / Chapter Skim
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7 Issues of Law, Regulation, Information, and the Environment for Contraceptive Research and Development
7 Issues of Law, Regulation, Information, and the Environment for Contraceptive Research and Development
Pages 236-340
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From page 236... ...
pharmaceutical industry, it incorporates information about firms outside the United States that are involved in some aspect of contraceptive research and development and raises issues deriving from the ongoing processes of industrial globalization. Stage I, "the contraceptive revolution," can be said to have begun in 1951 more or less officially, when Carl Djerassi at Syntex filed a patent for norethindrone; it ended in the early 1970s.
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Although oral contraceptives accounted for just under 4 percent of the prescription drug market as the 1980s began, there were more liability suits associated with that method each year of the new decade than for any other drug product (Djerassi
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In 1972, the World Health Organization's Special Programme of Research, Development, and Research Training in Human Reproduction was established. Among the nonprofit entities that were either created or that became more active during this stage were the Population Council's Biomedical Research Center, Family Health International (FHI)
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. In the United States a new pattern evolved, one of collaborative effort among public and private organizations: funding agencies, basic research facilities, university-based scientists, clinical trials organizations, nonprofit organizations, and smaller pharmaceutical companies, some of which were outside the U.S.
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: LHRH analogues • Alphatron, Vastech Medical Products, Population Council: nonsurgical vasectomy devices • Upjohn, Dow Corning, Population Council, Battelle Institute, London International, Roussel UK: hormone-releasing vaginal rings • London International, National Institute of Child Health and Human Development, Family Health International: polyurethane male condom (e.g., Avanti) • Tactyl Technologies/SmartPractice, Contraceptive Research and Development (CONRAD)
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In other words, R&D investment, while intense throughout the biopharmaceutical industry, is most heavily concentrated in the emerging company subsector. Industry estimates are that, despite the large investment of public funds in disease-specific areas, 92 percent of all drugs approved between 1981 and 1990 trace their origin to private-sector R&D programs.
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SOURCE: Disclosure Annual Industrial Database, 1995. products presently in clinical trials were licensed from small companies and, to a lesser extent, universities.
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. The pharmaceutical industry has been adapting to these realities by essentially reconfiguring itself.
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and for biotechnology firms, "pharmacoeconomics," or the linking of quality-of-life and outcome measures with efficacy data in the design and conduct of clinical trials, will be essential; it will be crucial in the development of products for "difficult audiences." The need of the large pharmaceutical industry to purchase technology in some form is highly significant for the biotech industry and there is a sense that the redefinition of the pharmaceutical industry offers biotechnology a much wider set of opportunities to prove its value. As noted above, because biotechnology firms essentially invest all of their assets in research and development, they are far from losing their identity as the incubators of much of the progress in human health care (Lee and Burrill 1995)
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. Financial analysts are unable to describe public biotech companies to their investment clients using standard financial parameters because the majority of these companies are essentially R&D operations without products, revenues, and earnings.
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Cost-based pricing Positioning on value Mega sales force Multiple distribution techniques Customer service Customer alliances • Disease management • Outcomes studies • Education • Customized phase III and IV clinical trials CONTRACEPTIVE RESEARCH AND DEVELOPMENT Science/sales driven Customer/market driven
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Evolution of Successful Products Innovative products Innovative products Innovative products supported by global sales, service, and market infrastructure Competitive products supported by strong infrastructure Competitive niche products Competitive niche products Competitive niche products SOURCES: Burrill GS, KB Lee Jr. Biotech 94: Long-Term Value, Short-Term Hurdles (The Industry Annual Report)
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CROs are basically third parties that provide research services on a contractual basis, focusing primarily on designing, conducting, and analyzing human clinical trials. Many CROs can also provide preclinical animal testing at
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While CROs have existed for more than two decades, a confluence of factors seems to be driving a resurgence. These factors include pricing pressure from organized buyers; a relative paucity of investment capital; staff cutbacks; lack of expertise in most biotechs in clinical development and in regulatory affairs; perceived increases in regulatory burdens; and buyers' demands for costefficiency data which add a whole new layer of complexity to clinical development strategies.
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. Globalization Another effect of the changes in the larger environment for "big pharma" and the biotech industry is that the industry has become increasingly TABLE 6-2 Strategic Alliances in the Biopharmaceutical Industry, 1993 to Mid-1995 Number of Transactions Year to Date 1993 1994 6/30/95 Large pharmaceutical company alliances with biotech company 69 117 73 Biotech-and-biotech alliances 43 52 26 Total 112 169 99 SOURCE: Vector Fund Management.
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companies to initiate clinical trials more quickly and possibly gain market access sooner; other operational and tax advantages also add to the general offshore allure. Finally, the biotech industry has globalized to include countries in Latin America, Eastern Europe, China, India, and the Pacific Rim, which recognize the promise of biotechnology, offer new markets, and serve as sources of innovation.
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of companies 225 194 16 1,231 1,107 115 Employees 37,000 33,000 12 79,000 70,000 13 aThe MERCK Biotech Index is a measure devised by Ernst and Young, which assesses the entire developing biotech industry as compared with Merck's ethical pharmaceutical business. SOURCES: Ernst and Young Biotech Industry Annual Reports: Biotech 93, 94, 95, 96.
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. Prominent among the arguments are that the regulatory environment might be less stringent elsewhere, that the pressures of liability would be less severe, that the political and ideologic environment might be less complex, and that clinical trials would be less costly.
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Mathieu, New Drug Development: A Regulatory Overview (3rd ed.)
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In addition, bringing a new contraceptive product to market takes years because of the long development cycle, numerous clinical trials, and complex regulatory approvals that are needed. Thus, today's dearth of new contraceptive products reflects decisions by pharmaceutical firms not to pursue research or development of new contraceptive products that were made 10–20 years ago.
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The decisions of firms, especially those previously active in contraceptive development, not to pursue development of new products, or to exit this product area altogether, also can negatively affect the stock of expertise needed to develop new products. Firms in the pharmaceuticals industry also typically specialize to some extent in specific types of products or therapies, which reflects the fact that they have accumulated considerable scientific, technical, and marketrelated knowledge that is specific to these areas and may not be relevant elsewhere.
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Because existing contraceptive products (e.g., IUDs or oral contraceptives) are relatively inexpensive, they impose a "ceiling" on the feasible price in mass markets for new alternatives, and therefore depress projected returns from contraceptives relative to other pharmaceuticals or medical devices, whose delivery is more frequently covered by third-party reimbursement.
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Obviously, for firms with considerable expertise in this product field, this gap between the hurdle rate for contraceptives and other products will be lower, and this gap will be affected by many other influences as well. Nevertheless, these factors appear to depress the projected returns for commercial contraceptive development projects relative to those in other areas in which scientific advances may offer equally enticing product development possibilities.
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Ortho is a Johnson and Johnson subsidiary, Wyeth-Ayerst and Whitehall are part of American Home Products Corporation, and Organon is a subsidiary of Akzo NV. Only one, Ortho, which markets oral contraceptives, diaphragms, and spermicidal preparations is present in more than two product lines (Frost and Sullivan 1993)
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U.S. Contraceptives and Fertility Product Markets.
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* Oral contraceptives Dongkuk Trading (Korea)
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Polifarma Oral contraceptives Reddy Health Care Condoms RFSU of Sweden Condoms Roberts Oral contraceptives Rugby Labs Oral contraceptives (Genora) Safetex Condoms
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b Spermicides Wisconsin Pharmacal Female condom (Reality) Wyeth-Ayerst Oral contraceptives (Lo-Ovral, Nordette, Triphasil)
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The international picture is also one of concentration. In the case of oral contraceptives, which account for the overwhelming bulk of all contraceptive revenues worldwide (over 80 percent in 1992)
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U.S. Contraceptive and Fertility Product Markets.
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These are typically with the public sector (primarily NIH/ NICHD [National Institute of Child Health and Development] and WHO/HRP [the World Health Organization's Human Reproduction Programme]
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AM Resource Bactericidal gel NIH: NICHD Apex Medical Nonlatex condoms NIH: NICHD London International Technologies Group Apothecus Vaginal film WHO/HRP NIH: NIAID FHI Aphton hCG immunocontra- WHO/HRP ceptive Applied Medical Estrogen-free minipill Dutch government Research, Ltd.
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Femcap Inc. Cervical cap CONRAD FHI Gynetics Combined oral contraceptives Integra Spermicide with CONRAD polymer barrier
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shape IUDs (CUSafe 300, Mark II, MLCu 375, Ombrelle-250) ; vaginal rings; combined oral contraceptives; zona pellucida (ZP)
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NIAID, WHO/HRP (licensing agreement for Phase II clinical trials, manufacture, distribu tion) Schering AG Antiprogestins other than WHO/HRP (Germany)
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CONRAD Triad Ventures Petrus Fund Woodlands Venture Reproductive Biotech nologies/Bangalore, India (collaborative agreements) NOTES: AVSC = Association for Voluntary Sterilization; CONRAD = Contraceptive Research and Development Program; ICMER = Instituto Chileno para Medicina Reproductiva; NIH/NICHD = National Institute of Child Health and Human Development; FHI = Family Health International; RTI = Research Triangle Institute; PI = Principal Investigator; WHO/HRP = World Health Organization's Human Reproduction Programme; CRADA = Cooperative Research and Development Agreements; SBIR = Small Business Innovation Research (grants)
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Of particular interest is the picture of some small start-up firms, for example, Applied Medical Research, Aphton, ContraVac, and Reprogen, all of which are struggling to find partnerships and support for entry with new technologies that are at varying stages of research and development. Current Industry Involvement in Women's Reproductive Health It may be illuminating to compare this picture with a recent picture of what is going on in the biopharmaceutical industry in connection with the larger field of women's reproductive health, excluding contraceptives, and anti-infectives for sexually transmitted diseases (see Table 6-10 and Table 6-11)
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Nomenclature makes a difference, too: The accounting for "family planning" will not be the same as the accounting for "reproductive health," and "contraceptive research and development" will be subsumed under each of these rubrics in distinctive fashion. Also, the frontiers between basic research and everything else are sometimes hard to define; categorization of research in particular areas or further along the trajectory of development of individual methods may also be defined variously (Atkinson et al.
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Binax characterize human sperm to measure male fertility; immunocontraception Cygnus Therapeutics Estrogen/progestin 7-day Menopausal symptoms American Home Products Cygnus Therapeutics Estrogen/progestin 3.5-day Menopausal symptoms American Home Products Cygnus Therapeutics Ethinyl estradiol 7-day Menopausal symptoms Warner-Lambert Cygnus Therapeutics Estradiol 7-day Menopausal symptoms Warner-Lambert, Sanofi CONTRACEPTIVE RESEARCH AND DEVELOPMENT
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and osteoporosis Noven Pharmaceuticals Progestogen transdermal Menopausal symptoms Rhône-Poulenc Rorer and osteoporosis Pharmos Estradiol-CDS Post-menopausal TheraTech Estradiol, transdermal Menopausal symptoms TheraTech Estradiol/progestin, Menopausal symptoms transdermal TheraTech Female hormone replace- Oopherectomized women Solvey ment therapy, transdermal SECTORAL ROLES IN CONTRACEPTIVE RESEARCH AND DEVELOPMENT SOURCE: Goldman Sachs.
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antiviral (beta interferon) Burroughs Wellcome Genital herpes, antiviral n.d.
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house research and funding external research at various points along the R&D pipeline (Rockefeller Foundation 1995b)
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. USAID's major product accomplishments include development and/or evaluation of tubal bands and clips for female sterilization; evaluation and introduction of low-dose combined oral contraceptives and progestin-only pills; supporting the research that led to development of CONTRACEPTIVE RESEARCH AND DEVELOPMENT
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At present, USAID cooperating agencies (CAs) are involved with preclinical and clinical testing of two woman-controlled barrier methods, Lea's Shield and Femcap; testing of nonlatex male condoms; preclinical testing of compounds and formulations for spermicidal and virucidal activity; and clinical testing of vaginal contraceptive film preparations.
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It has expanded its original mandate, which was to test and improve available contraceptive methods, to include development of new methods, the study of the impact of contraceptive use on the health of developing-country populations, and the strengthening of the research capacity of developing countries. As of 1995, around 15 percent of its overall budget was devoted to contraceptive development of new contraceptive methods, primarily in the clinical trials phase.
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The organization has worked with colleagues in 39 developing countries (including Bangladesh, Brazil, Egypt, India, Indonesia, Mexico, People's Republic of China, Philippines, Thailand, Turkey, Vietnam, and Zimbabwe) to conduct feasibility studies and provide technical assistance in technology transfer and good manufacturing practices in connection with the production of condoms, injectables, Copper-T IUDs, oral contraceptives, and spermicidal products.
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United Nations Population Fund UNFPA provides support for contraceptive development activities, notably its support to (UNFPA) WHO/HRP, as well as a major procurement activity for developing countries.
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The GOPRC invested at least twice those amounts toward the same objectives. The Chinese National Research Programme for Family Planning has focused its priorities on development of new types and improvement of currently available IUDs, long-acting steroid contraceptives (once-a-month oral contraceptives, implants, SECTORAL ROLES IN CONTRACEPTIVE RESEARCH AND DEVELOPMENT vaginal rings, monthly injectables)
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toward mobilizing during the next decade "the resources to ensure availability of high-quality reproductive health and family planning services to all women in the developing world." Andrew W Mellon Foundation The Andrew W
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SOURCES: Bilian X, Advances of Contraception in China, Shanghai: National Research Institute for Family Planning, 1994. Contraceptive Development Branch, NICHD, Report to the National Advisory Child Health and Human Development (NACHHD)
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Fourth, as in the case of the foundations, federal funding for contraceptive development continues to be substantially less than the amount devoted to basic research. Since 1981, over 50 percent of all federal funding for population research has gone to basic research in reproductive biology, with studies of reproductive endocrinology dominating heavily.
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The Burroughs Wellcome Fund, concerned about assuring maintenance of and fostering increase in the cadre of scientists for the field, made a first-year investment of $800,000 toward the training of scientists. The Rockefeller Foundation committed $14.75 million toward mobilizing during the next decade "the resources to ensure availability of high-quality reproductive health and family planning services to all women in the developing world" and, with Andrew W
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1.4 1.7 1.3 1.9 1.5 1.5 Contraceptive development n.d. 0.7 0.7 0.9 1.1 1.1 1.5 Total n.d.
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:196–207, 1985. bThe first row of figures presents the approximate values for contraceptive development research through FDA approval; the second row is that portion of USAID support for population that goes to biomedical research, which constitutes about 50 percent of all population research.
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and Catherine T MacArthur Foundation, the Hewlett Foundation, and the David and Lucile Packard Foundation all allocate some funding to population and reproductive health, but their funding streams are oriented toward policy, social scientific research, and family planning services.
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The public sector also has particular strength and expertise in supporting the later stages of contraceptive research and development, for example, the clinical trials necessary to obtain the data required by the drug regulatory process. Any function that can expeditiously catalyze these sorts of ad hoc mechanisms across and within sectors could provide considerable value added.
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International Research in Reproductive Health: A Guide to Agencies/ Organizations. Paper prepared by World Health Organization Special Programme for Re search, Development and Research Training in Human Reproduction.
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3. In 1994, The Rockefeller Foundation stated its commitment to a strategy for resource mobilization in the field of population, including contraceptive research and development, noting that rather than adding its limited resources to an already impoverished field, it would invest in activities that would draw in more resources, help public sector programs to achieve their mission, and bring industry back.
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In contrast, the study committee concluded that the impact of product liability litigation, particularly on the cost and availability of liability insurance, was a very large contributor to the climate of disincentives for the development of contraceptive products. The weightiest aspects of litigation were its unpredictability and the fact that evidence of compliance with FDA regulations was granted no special status in liability lawsuits in most states.
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The chapter then turns to an area where law, culture, politics, scientific research, medicine, and the thoughts and needs of contraceptive users intersect: the area of information. The chapter closes with a scan of those aspects of the environment that are most critical in generating the controversy that so often attends the development and use of modern contraceptive technologies.
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. Historically, however, the FDA has imposed special requirements on contraceptive products, particularly in the area of safety data, requirements which have had the practical result of delaying or obstructing the approval of such products.
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, the FDA rejected the application, largely on the ground that the drug had produced a significant increase in benign and malignant mammary tumors in beagles. Subsequently, however, the results of large-scale epidemiologic studies of actual users of Depo-Provera in developing countries, conducted by the World Health Organization and others, became available and showed that DMPA had at most a weak association with an increased risk of breast cancer, and that such risk, if any, was of the same order of magnitude as that posed by oral contraceptives (Jordan 1992)
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Thus, while Reality's effectiveness in this regard was perhaps not as high as that of some alternative contraceptive products, it clearly offered much better protection than nothing. For a woman not using an alternative method, and whose partner was himself unwilling to use a condom, the female condom could well mean the difference between less-thanperfect (but still significant)
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vaginal contraceptive products to conduct expensive and time-consuming clinical trials and obtain approved new drug applications (NDAs) in order to continue to market their products (FDA 1995b)
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For contraceptive products that combine, for example, a device component with a drug component, the combination product policy reduces the chances of review delays caused by jurisdictional confusion within FDA. The intercenter agreement between the drug center and the devices center lists, for instance, a
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. Prospective Regulatory Changes A number of changes being contemplated or implemented as part of current FDA reform initiatives could be of specific benefit to the development of contraceptive products.
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. Inclusion of Women in Clinical Trials In July 1993, the FDA released a new Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs, which modifies and revises the section of its 1977 guidelines that recommended exclusion of women from Phase I and early Phase II of drug development.
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Human physiology and individual medical and personal histories are simply too diverse and unpredictable, as are other contextual variables that cannot be incorporated into clinical trials. The law requires manufacturers to warn not only about known risks but about foreseeable risks that should have been known had the manufacturer applied "reasonable, developed human skills and foresight." While risks designated as "unexpected and unknown" will not trigger strict liability, sellers still are deemed to be experts and are imputed to have all "knowledge of the product's risks based on reliable and obtainable information" (Flannery and Greenberg 1994)
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. In the context of product liability, tort law encompasses both negligence, which is based on fault, and strict liability, which is based on no-fault principles (Prosser and Keeton 1984)
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. It is the last two areas that are pertinent to both product liability and research liability.
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that the plaintiff was injured thereby. [Product liability cases are not usually based on this theory owing to the common requirement of "clear and convincing" evidence.]
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In research liability, legal actions for injury based on a negligence theory often involve the doctrine of "informed consent." There is a difference between the nature of consent needed to avoid a legal action for battery, which is a form of assent to a bodily intervention that is sometimes termed "simple consent," and what is needed to avoid an action for negligence, which requires "informed consent." The latter is defined as consent based on the disclosure of all facts, including the risks and benefits of the proposed intervention, as well as alternatives and their risks and benefits, that are necessary to form the basis of willing, uncoerced, intelligent consent by the
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. Strict Liability Strict liability is fairly new in tort law, but this less-than-definitive theory leaves much room for interpretation.
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In some of those states, a wrongful death action for a stillborn child is allowed only if the child was deemed to have been a viable fetus at the time the injury occurred; in other states, a wrongful death action is allowed regardless of the fetus's initial viability. Current Proposals for Tort Reform If a manufacturer loses a suit, there are three kinds of damages that can be awarded to a claimant: • Compensatory damages, which encompass economic damages for whatever economic injury may have occurred, for example, medical expenses, loss of income, or estimates of future judicial expenses; as well as
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Recognition of the need for a set of standards governing product liability on a federal level is, nevertheless, not new. Since at least the 101st Congress, members of both houses have made attempts to address the issue and some state legislatures have, for the first time, enacted legislation that, in some circumstances, limits damages awards against defendant manufacturers.8 The National Vaccine Injury Compensation Program (NVICP)
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It is perilous to take up the topic of legislation that is still in the making, since much of its content may change and, of course, there may be none.9 After all, product liability legislation has been vigorously debated since it was first proposed in the early 1980s. Nonetheless, there are generic components whose inclusion in any final legislation could contribute significantly to enhancing the environment for improving existing contraceptives and developing new ones, in ways that will better respond to current national and international public health needs and demands.
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Approval which a medical device or drug had punitive damages against manufacturers Defense won approval from the FDA before of products that had won approval from (Government the product was sold.
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Statute of Limit the time for filing product liability Limit the time for filing a product No time limit provision. Repose cases for most products to 15 years after liability suit to 20 years after a product is delivery.
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by the FDA. The gist of such an "FDA Defense" -- sometimes termed "Government Standards Defense" or "Regulatory Defense" -- is as follows: If it is established that an injury-causing aspect of a contraceptive drug or device was in compliance with all applicable requirements of U.S.
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FDA compliance is, indeed, a shield, but noncompliance makes that shield useless. Arguments raised against a government standards defense often mention the histories of diethylstilbestrol (DES)
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Yet another possible variation would be articulation of a set of explicit standards for behavior warranting punitive damage awards that would provide clearer guidance for judges and juries; those who propose this variation note that punitive damages thereby become more predictable in some respects and more precisely targeted on the kinds of behavior that most merit strong deterrence (Garber 1993)
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The buyer must also be producing implants approved by, and registered with, the FDA, pursuant to the Federal Food, Drug, and Cosmetic Act, an oblique reflection of the relevance of government standards to defense against liability. Whether this sort of statutory protection will entice bulk suppliers back into the medical device market cannot be predicted.
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To protect themselves, manufacturers and institutions must purchase product liability insurance, often prohibitively expensive or simply unavailable. This constrains research and the marketing of new drugs and devices and has already affected development of new means of fertility regulation and the testing of new vaccines against infectious diseases.
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involved in clinical trials funded by the NIH. Legal Cases Related to Contraceptive Development The 1990 NRC/IOM contraceptive technology report, in its summary of trends in litigation involving contraceptives, noted that, while every single contraceptive method then available had been the subject of product liability litigation, the history of each was diversely patterned.
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Two-thirds of the suits were pending in federal courts and were consolidated for pretrial purposes in Beaumont, Texas, as master class action complaint MDL-1038,13 on counts of negligence; product liability; various permutations of fraud, misrepresentation, and breaches of warranties; and allegations of scarring and side effects (U.S. District Court, Beaumont, Texas 1995)
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The rates of removal difficulties are within the expected rates stated in the Norplant labeling, as are the reported adverse events attributed to the levonorgestrel component, which do not differ substantially from those alleged against oral contraceptives over the last 20 years. As for silicone issues, there is no reputable scientific opinion linking the Silastic tubing used in Norplant with any autoimmune or related problems in women; the silicone elastomer used as the delivery system for Norplant has been used for over 30 years in a wide variety of medical products, including catheters, shunts, pacemaker leads, joint replacements, and tubal litigation bands.
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As this report goes to press, the fate of product liability reform in the United States is uncertain and regulatory reform is still in process. Yet, even if there are changes, in the United States or elsewhere, those changes and any subsequent proposals for reform need to be evaluated in terms of the way they meet broader social and economic goals since they quite naturally serve a variety of goals and interests.
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This model serves the goal of protecting individual users, innovators who serve a public interest in product development, and public service. The model serves distributive justice regarding products whose availability serves the public interest, but it denies the goal of individualized justice in that it excludes an individual victim of injury from entering the "forensic lottery" that offers the prospect of windfall riches in the form of punitive damages.
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The framework would provide a range of public sector incentives to encourage the private sector to respond to reproductive health needs as and when they arise. This report has identified the need for combined barrier methods, male methods, postcoital and once-a-month methods, and novel non-barrier female methods with fewer systemic effects, and has pointed to the potential of immunocontraception for providing leads to innovation in some of these priority areas.
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. As women are increasingly included in clinical trials, there may be more coincidence between the universe of research and the tort system in connection with research-related injury (IOM 1994a)
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. Many women worldwide lack access to the full and accurate information, sympathetic and respectful provider-client interaction, continuity of care, and availability of other basic reproductive health services that are the sine qua non for both informed consent,
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. As the histories of oral contraceptives and intrauterine devices make clear, the first drug in a new therapeutic class is unlikely to be the optimal version.
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Concurrent with these shifts is a consumer movement which incorporates notions of the "educated patient," patient autonomy, health promotion, client-centered care, and the significance of client-provider information exchange. In the context of contraceptive use and family planning, these have become standard themes.
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Still, a single categorical location where intelligible, accurate information about the technical aspects of individual contraceptive technologies -- their risks, side effects, contraindications, benefits, and proper use -- is consistently available could serve to anchor the information base. It is also the case that the media pay attention to package labels; in the case of the Reality female condom, an apparent misreading of the label published in a major trade journal, sent the manufacturer's stock plummeting (AIDS Alert 1994)
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. At the same time, the disjoints foster dissatisfaction with current contraceptive methods and, somewhat ironically, strong support for continued research and development of new ones (Forrest 1994b)
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Wade, and efforts to eliminate the national family planning program are ample indication of the durable, penetrating character of these matters. For example, the State of Pennsylvania just, for the first time, appropriated state funds for contraceptives but excluded Norplant, Depo-Provera, and IUDs from being provided because they are considered abortifacients, a definition that is scientifically incorrect.
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and by subsidized bulk procurement for vaccine provision to developing countries that has been able to evoke positive commercial response (Mercer Management Consulting 1994)
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Ethics and Human Values in Family Planning: 22nd CIOMS Conference, Bangkok, Thailand, 19–24 June 1988. Geneva: WHO Special Programme of Research, Development and Research Training in Human Reproduction and Council for International Organizations of Medical Sciences.
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Family planning: The responsibility to prevent both pregnancy and repro ductive tract infections. IN Reproductive Tract Infections: Global Impact and Priorities for Women's Reproductive Health.
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Foote SB. Product liability and medical device regulation: Proposal for reform.
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Clinical Trials. FJ Manning, M Swartz, eds.
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Paper presented at the Women in Clinical Trials of FDA Regulated Products Workshop, Washington, DC, Food and Drug Law Institute, 5 October 1992. Richter J
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Family Planning Perspectives 26(2)
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In pharmaceutical testing, it usually refers to randomized clinical trials, using either a placebo or an established therapeutic as the control. Clinical studies also include the early-phase safety studies in health volunteers, postmarketing studies to expand indications for use or investigate safety and effectiveness in special populations, and investigations of the outcome of health interventions (Flannery and Greenberg 1994)
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. Of high relevance for the area of research liability were the awards for battery made to women involved in clinical trials of DES who had not been informed that they were part of a study (IOM 1994a)
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