Population Council Research that makes a difference

Multipurpose prevention technologies (MPTs) that address women's sexual and reproductive health needs—through preventing unintended pregnancies and/or sexually transmitted infections (STIs), including HIV—could make a major contribution to global health. Unsafe sex is an enormous public health problem for women, leading to the second largest cause of illness and disability worldwide. It is also a major factor in female mortality, especially in low-resource settings.

MPTs are a unique and specialized subset of what regulatory agencies refer to as combination products. They often do not fit into the discrete categories—drug, device, or biologic—used by regulators to assess products. As such, MPTs face an uncertain regulatory environment that can serve as a major disincentive to investment and an impediment to advancing candidate products.

The current interest in scientific innovation provides an opportune moment to accelerate the development of combination products, including MPTs, for sexual and reproductive health. Combination products represent cutting-edge science, employing new tools and techniques for product development. They also represent a promising area for health improvements and potentially greater user adherence. In some instances, combinations may lend themselves to more economical product development, lower costs, and potentially larger markets.

The US Agency for International Development (USAID) is injecting new energy into efforts to develop and deliver MPTs by supporting complementary programs to foster creativity and strategic thinking on product development, innovative approaches to trial designs to test new products, and regulatory pathways for product development and licensure. The Population Council is playing a central role in this effort by spearheading work to clarify and inform regulatory pathways for MPTs.

Working with the World Health Organization and other key stakeholders, Council project director Martha Brady and her colleagues will stimulate thinking and promote problem-solving around MPT regulatory pathways with the goal of influencing and shaping regulatory approval processes for MPTs, and developing a road map of possible regulatory pathways as a foundation for their approval. The Council will engage key regulatory authorities such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and drug regulatory authorities (DRAs) in select developing countries to review and understand existing guidelines and explore opportunities for stimulating new thinking and approaches. Thought leaders and experts from relevant fields—contraception, prevention of STIs including HIV, product development, clinical study design, and regulatory affairs—will also help shape regulatory processes for MPTs.