It has been some time since we provided a detailed update on the status of FDA’s user fee legislation making its way through Congress, so that’s what is on tap for today. The House passed the lengthy FDA Reauthorization Act (FDARA) on July 13, 2017 as H.R. 2430, and House members have now left Washington, D.C. for the traditional August recess.
Although the previous self-imposed congressional deadline of completing work on FDARA by the end of July has passed, FDA Commissioner Scott Gottlieb informed agency employees via email on July 24th that he would not be sending out any lay-off notices to user fee-funded staff “unless and until September 30 passes without reauthorization.” The publicizing of this policy decision by the Commissioner may have been intended to signal to the Senate that the sky is not falling (yet), but that they need to get to work. Continue Reading August 2017 Is Here – Will FDARA Get Done Soon?