Development of a new male contraceptive remains a hot topic, despite ongoing business and scientific obstacles. Earlier this month, the Journal of the American Medical Associationpublished Rita Rubin’s summary article, “Work Progresses on Male Contraceptives, but Hurdles Remain.”
The overview highlighted some key economic and regulatory considerations impeding development of both hormonal or non-hormonal options.
The Eunice Kennedy Shriver National Institute of Child Health and Human Development,(NICHD) funds a significant male contraceptive research portfolio. Daniel Johnston, PhD, Contraceptive Research branch chief, noted that his agency is not “in the business of ushering new products through the U.S. Food and Drug Administration and marketing them, once approved. Anything we develop, we have to get somebody to take it. There has to be a partnership at the end of this.”
To date, major pharmaceutical players have not been convinced that sales would be sufficient to offset the cost of Phase III clinical trials, commercialization, and product introduction efforts. NICHD hopes to overcome this hurdle through the use of cooperative research and development agreements (CRADA) to encourage public/private partnerships.
Comentários