USA – NASEM Calls on WHO to Expand its Prequalification Program

The National Academies of Sciences, Engineering, and Medicine (NASEM) on Wednesday published a new report outlining ways to strengthen regulators worldwide, and one of the report’s recommendations is for the World Health Organization (WHO) to expand its prequalification program for medical products.

The prequalification program is a way for the WHO to increase access to certain HIV/AIDS, malaria, tuberculosis and other generic drugs and active pharmaceutical ingredients in low- and middle-income countries.

The program is necessary, as NASEM estimates poor quality vaccines cause about 70,000 deaths from childhood pneumonia each year and poor quality antimalarials cause between 8,500 and 19,800 deaths per year (based on WHO estimates of 435,000 malaria deaths a year, 93% of which occur in Africa).

“A 2019 assessment found that every dollar spent in running prequalification returns 30 to 40 times that amount and in savings during procurement and by leveling the playing field to allow good manufacturers in low- and middle-income countries entry to international markets,” NASEM said in its report, which was sponsored by the US Food and Drug Administration (FDA)…