Did PDUFA V Pass Too Quickly?

This article notes the swift completion of negotiations between House and Senate staff on PDUFA V (the FDA Safety & Innovation Act), and asks whether the bill could have been improved with additional time to continue the negotiations. The article quotes Catalyst’s Anne McNickle, Director of Communications and Research, on the pending Supreme Court decision on the health reform law (Affordable Care Act) and its impact on timing of user fee legislation: “If the court vacated the law and the user fee bill was still under debate, it could have allowed for some significant political tinkering with PDUFA. Essentially, the user fee bill is such a big lift on its own that Congress wanted to avoid bogging it down with possible ACA-related provisions.”
Did PDUFA V Pass Too Quickly?

The Pink Sheet

2017-11-19T18:31:51+00:00