An industry perspective on the evolution of hormonal contraceptive development☆
Abstract
This article examines key drivers for the evolution of hormonal contraceptive research, including changes in governmental (e.g., Food and Drug Administration [FDA], National Institutes of Health [NIH]) regulatory policies and pharmaceutical drug development. The modernization of regulatory guidances served as the catalyst for hormonal contraceptive research and set the foundation for the study of additional aspects related to women's health and the inclusion of women in clinical trials in both the public and private sectors. The trends in hormonal contraceptive development over the past fifty years provide an interesting case study of the changes in women's health care (WHC) research from an industry perspective. In both WHC research in general and hormonal contraceptive development in particular, an effort to improve the overall health of women has remained an overarching theme.
aTechnical Assistant Director, Clinical Communication, Ortho-McNeil Pharmaceutical, USA
bDirector, Women's Health Care Research, Ortho-McNeil Pharmaceutical, USA
☆ Hormonal contraceptive research has been influenced by governmental and non-governmental public sector institutions as well as the pharmaceutical industry
The central objective for all development partners has been enhancement of public health. Divergence on secondary objectives does not diminish the core goal.