With oral contraceptives in widespread use, epidemiologists must maintain appropriate surveillance through the next 20 to 40 years to follow the effects of current and new formulations of the pill when used from an early age. They must also establish studies of risks and benefits to ensure the relative safety of new formulations. These future studies must (1) involve many thousands of cases and controls to permit statistically valid analyses of subgroups of users (e.g., individuals who used the pill prior to their first pregnancy), and (2) follow sufficient numbers of women for enough years to measure how long any possible effect persists after discontinuing oral contraceptive use. These are studies of daunting size and duration; nevertheless, they must be undertaken—and the necessary resources must be set aside to conduct them—to protect the health of American women.

The committee calls attention to the opportunity for international, cooperative research, owing to the complementarity of European and North American research data. There is enough variation in both exposure to oral contraceptives and opportunities for surveillance among the countries gathering data that a coordinated future research plan offers worldwide benefits. It is also important to note that some oral contraceptive formulations that are likely to become available in the United States over the next five years are already in use in a number of countries worldwide, including many European nations.

Further, the committee recommends that the Food and Drug Administration consider premarketing and postmarketing requirements as an integrated whole. There is a need to devise ways of spreading the investment already required by manufacturers, and ultimately paid for by users, in such a way as to maximize the information on safety that will result.


The success and popularity of oral contraceptives as a means of avoiding conception are both a tribute to their efficacy and a reflection of the paucity of effective alternative means, particularly for young women. The committee underscores the urgent need for research and development of a broader array of contraceptives, including more effective barrier methods and nonsteroidal methods. It is not feasible to wait for resolution of the uncertainty about oral contraceptives as a potential risk factor for breast cancer before energiz-

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