FDA UPDATE ON EBOLA

FDA Update on Ebola

By Janet Woodcock, MD:

The FDA has been working a tremendous amount, I think, behind the scenes to help with the Ebola crisis. We’ve been working with the WHO, with other governments, with private companies, with other government agencies in the United States. 

Basically the problem that we all have is that diagnostics, therapeutics, and vaccines for Ebola are all in the investigational stage. In other words, they hadn’t really been studied very much in people. We don’t know about their performance. 

They hadn’t been approved by the FDA. But there’s a crisis and we need to move these forward and make them available if possible. And so, some of the problems that we’ve been seeing is just production. Early in the development of therapeutic products and vaccines, they are only made in very small amounts, enough to study a few volunteers and maybe a small clinical trial. And so, we’re helping the manufacturers scale up their manufacturing to make larger quantities available. We also are very interested in making sure as we provide access to these investigational products, that we also gather evidence so that we understand how they work, and then they can be made more widely available. 

A part of FDA that most people don’t understand is that we regulate the quality of the products, not just their safety and their efficacy, but to keep them good, their quality.