Welcome to another edition of This Week at FDA! There were some major developments this week with potential ramifications for FDA in the coming years, as well as many other updates and actions from the agency. We hear that HHS has transmitted three of FDA’s user fee packages to Congress – with one notable exception – and, as we reported on Thursday, FDA is one step closer to having a permanent commissioner.
Earlier this week, we read that FDA and the medical device industry were still about $1 billion apart in their negotiations over MDUFA V, just days before the deadline set by Congress to submit the agreement. Now, Politico reports that the Department of Health and Human Services (HHS) has transmitted the packages for PDUFA VII, GDUFA III and BsUFA III to Congress on time, with MDUFA V still awaiting finalization.
On Thursday, the Senate HELP committee voted 13-8, with one member not voting, to advance Robert Califf’s nomination to the full Senate for a vote. While Califf picked up some Republican support, he will need even more Republican votes to overcome the handful of Democratic senators who have said they oppose his nomination. A conformation vote has not yet been scheduled…
