Contraceptive Development: Why the Snail's Pace?

Autor: Lisa Kaeser
Rok vydání: 1990
Předmět:
Zdroj: Family Planning Perspectives. 22:131
ISSN: 0014-7354
DOI: 10.2307/2135645
Popis: Current contraceptive methods are not well-suited to many Americans. More safe and effective methods would be desirable. A report, "Developing New Contraceptives: Obstacles and Opportunities" was released in January 1990. It summarized 2 years of data collection by the Committee on Contraceptive Development which includes pharmaceutical company executives, physicians, reproductive biologists, public health, legal, and public policy experts, demographers, and economists. Barrier facing the development of new methods in the US were analyzed and ways to speed up research suggested. Particularly ill served are teenagers, young mothers, and comparatively older couples. The health risks of pregnancy, delivery, and labor "may be underrated." The pill is now the most common form of contraception in the US, followed by female sterilization, condoms, and vasectomy. 95% of women, aged 15-44, who have ever had intercourse, have used 1 or more contraceptive methods. Contraceptive discontinuation and failure rates are high, too. No fundamentally new contraceptives have been approved for use since the IUD and the pill in the 60s. Modifications of existing methods are in clinical trials. Obstacles cited were attitudes of the public, federal regulations and product liability, and the organization of and resources available for research. Public attitudes are very conservative. There is no great demand for more products. Since the 1960s, only 1 large pharmaceutical company (Ortho Pharmaceutical Corp.) is still involved in contraceptive research. Activity by small firms, nonprofit organizations, and universities has increased. Federal research funding in reproductive biology has only increased modestly since the mid 1970s. Private foundation support has dramatically declined. The time involved in the great costs of data required for Food and Drug Administration (FDA) approval have reduced research incentives. The average time it takes to get FDA approval has increased in the past 20 years. Weighing the risks and benefits of contraceptives is different from doing that with other drugs, yet FDA procedures do not allow for this. Product liability laws are different in each of the 50 states. Contraceptive development was greatly damaged by the mid 1980s insurance crisis. The committee recommended that the FDA put more importance on the effectiveness and convenience of new contraceptives. A comprehensive postmarketing surveillance system should be set up, and congress should pass a federal products liability law.
Databáze: OpenAIRE
Externí odkaz:
Nepřihlášeným uživatelům se plný text nezobrazuje