In this article, Catalyst’s Jill Hartzler Warner provides context for a potential future government shutdown, based on her experience at FDA.

The article explores the potential impact of a federal government shutdown across a range of FDA functions (as well as other agencies within HHS).

During the most recent shutdown, in 2013, Ms. Warner was Associate Commissioner for Special Medical Programs at FDA. Her comments focus on the fact that at that time, “the agency was struggling in general to make decisions about the slew of orphan-drug-designation requests,” and “that just gets exacerbated when you have a shutdown.”