Unceremoniously on January 31, 2006, an application was approved by the Nigerian drug regulatory authority and, with an official stamp of approval, an old gastric ulcer medicine—misoprostol —found a new, legal use in obstetrics in Africa’s most populous country.  The approval was significant as misoprostol had been widely used for years—off-label—to control a leading killer of women worldwide, postpartum hemorrhage (PPH).  Now, misoprostol can be legally imported and marketed for this use in Nigeria.  Shortly after the initial registration in Nigeria, and spawned by the results of a seminal randomized placebo control trial led by Dr. Richard Derman and colleagues, India followed suit in the summer of 2006. After assisting to achieve the world’s first regulatory approval of misoprostol for PPH in 2006, the non-profit organization Venture Strategies for Health and Development set out to facilitate regulatory approval of misoprostol and create access to these life-saving tablets throughout the developing world.

In eighteen short months, Venture Strategies’ efforts and negotiations have already prompted a cascade of regulatory approvals for the control of postpartum hemorrhage:  Tanzania approved in September of 2007, and a year later, Bangladesh, Ghana, Kenya Nepal, Sudan, Uganda, and Zambia have succeeded in registering the drug for this critical use. Additionally, Venture Strategies is assisting governments, private sector and non-governmental agencies preparing for rollout of prevention of postpartum hemorrhage programs.

Two years after that first success in Nigeria, have we reached a global tipping point with regards to misoprostol?    The recent spate of regulatory approvals, the FIGO/ICM statement, the World Health Organization’s recommendations for PPH prevention and investment by the donor community resulting in inclusion of misoprostol in safe motherhood programs make the answer unequivocally clear: we have reached the tipping point and misoprostol is here to stay.

The path forward for misoprostol has not been without its hurdles.  In Indonesia the effort to register misoprostol for PPH was rejected on April 30, 2008. Furthermore, registration itself, while critical, does not ensure use.  While registration often represents the first tangible step to enable availability and access, it does not guarantee that pharmacists stock the drug; providers prescribe, use or promote its use; or that women know about it and demand it.  What are needed are bold initiatives that integrate misoprostol into existing maternal health programs and elevate its use among other evidence-based initiatives to combat the stagnating maternal mortality rates across the developing world.  Governments, international aid agencies and non-governmental organizations must mobilize to enable the use of misoprostol where it could save the most lives: at home-births for those beyond the reach of facilities and skilled attendance.   Misoprostol must be viewed as complementary to, not antithetical to, worthwhile objectives to increase skilled attendance at birth and a shared goal of saving mother’s lives in childbirth with whatever feasible and safe means possible.  Integration of the use of misoprostol for PPH into maternal health programs through private and public partnerships has begun in countries such as Ethiopia, Bangladesh, Nepal, Tanzania, and Zambia. 

Within Venture Strategies, we are optimistic as the increased availability of these tablets could mean the difference between life and death after childbirth for millions of women who deliver in facilities without oxytocin, or lack access to skilled attendance at birth and deliver alone or with only their mothers or sisters to assist them.

Venture Strategies continues to receive welcome invitations from leading doctors and ministries of health in Africa and Asia to facilitate the regulatory process in their countries.  This signals that misoprostol is moving along the diffusion of innovation trajectory beyond that of intrepid innovators, or even early adopters, and is quickly becoming entrenched within the early majority of policy makers and program planners actively seeking to reduce maternal mortality in their countries.  It is official: misoprostol has tipped, and to the benefit of millions of women’s lives.