"Pearl" for the week of April 21, 2009

Does USAID provide Sino-Implant?

These Sino-implants sound really good. Is USAID buying them for programs it supports?

Not yet. In order for USAID to provide pharmaceuticals either they need to be USFDA approved or there needs to be sufficient alternative evidence of efficacy, safety and quality. As yet, the Sino-implant has not been approved by FDA or another globally-recognized regulatory agency. However, it has been approved by drug regulatory authorities in China, Indonesia, Kenya and Sierra Leone and dossiers are under review in 7 additional countries. An alternative approach to provide assurance would be WHO "pre-qualification" approval.

Four components do support the efficacy, safety and quality. 1) Sino-implant is very similar to the approved product Jadelle® and uses a very low-dose progestin levonorgestrel which has a long history of safe use. 2) 11 published studies following over 22,000 Chinese women for up 7 years support its safety and effectiveness. One of the larger studies was randomized with Norplant in the control group. Among the 1,000 women assigned Sino-implant, the 5-year cumulative pregnancy rate was 0.7% 3) Production in a new facility built in 2004 conforms to "Good Manufacturing Practices" (GMP) and 4) Independent tests are being conducted by FHI on an ongoing basis on the content and integrity of the product.

The "Pearls" offer answers to commonly asked questions about family planning. These "Pearls" are prepared by Dr. James D. Shelton, Senior Medical Scientist, Office of Population, United States Agency for International Development (USAID)