Regulatory Affairs Syndicator

Feminism and regulation collide: the Food and Drug Administration’s approval of the cervical cap.

Women Health. 1989;15(2):87-97

Authors: Gallagher DM, Richwald GA

In May 1988, the Prentif Cavity Rim cervical cap, a barrier method of contraception, was approved by the Food and Drug Administration (FDA) for contraceptive purposes in the United States. This paper describes some of the events leading to the approval of the cervical cap as a contraceptive. Of major interest is the unprecedented involvement of the feminist health movement in clinic-based research, policy making, and distribution of the cervical cap. The recall of the Vimule cervical cap, the use of lay health workers in fitting an experimental device, and the feminist providers’ response to the FDA’s regulation of the cervical cap are detailed.

PMID: 2781812 [PubMed - indexed for MEDLINE]