FDA Updates on Preparedness, Response Efforts on Ebola in Congo

The Food and Drug Administration yesterday provided an update on federal preparedness and the agency’s response efforts to the Ebola outbreak in the Democratic Republic of Congo. Among other actions, FDA Commissioner Scott Gottlieb, M.D., said the agency is focused on advancing the availability of an Ebola vaccine; facilitating the development of investigational drugs for treatment and supporting access to these products under appropriate regulatory pathways; and supporting the World Health Organization’s efforts to assess currently available data on investigational drugs for Ebola, as well as possible mechanisms to enable appropriate access outside of a clinical trial setting until scientifically sound clinical trials can be established. In addition, Gottlieb said the agency is taking action to protect consumers from sham products by monitoring for false product claims. There are no approved treatments or vaccines for Ebola available for purchase on the Internet, he said, and consumers who have seen fraudulent products being marketed or false claims are encouraged to report them to the FDA. According to WHO, as of May 30, there have been 60 Ebola cases reported, including 25 deaths, in the DRC.