How can a teratogen surveillance system be developed?
Current follow-up and casecontrol surveillance studies provide important information about teratogens, but these efforts form a patchwork at best. The United States does not have a coherent, organized system of teratogen surveillance. This is so because no agency has taken the responsibility for the broad direction of data collection and analysis that is needed to provide information on the teratogenic effects of newly marketed prescription drugs, as well as established prescription drugs and over-the-counter drugs. In keeping with its regulatory mission and obligations, the Food and Drug Administration (FDA) is the logical agency to establish such a system. This objective is now readily achievable. Specifically, the FDA should create a teratogen surveillance system based on a consortium of groups conducting follow-up and casecontrol surveillance studies, which could take advantage of the complementary strengths of the various post-marketing epidemiologic studies and infrastructures th
