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Public Statements

Food and Drug Administration Safety and Innovation Act

Floor Speech

Location: Washington, DC


Mr. PAULSEN. Mr. Speaker, I want to applaud, first of all, the chairman, the subcommittee chairman, and the ranking members for their leadership in bringing this bipartisan package to the floor.

Mr. Speaker, nearly every week, I get a chance to tour a medical device company in my district. And almost every week, I hear a similar story from these companies that talk about how the FDA has become so burdensome and bureaucratic and inefficient that they move the goalpost in the process of the device approval process. As a result, some of these companies are closing their doors. Some of these companies are investing overseas and moving jobs, as opposed to keeping them in their home State of Minnesota or here in the United States.

Unfortunately, it seems that Washington tends to thrive on these types of bureaucracies and inefficiencies. And I think the package that is before us today is designed to help correct that. The FDA review process needs to be rigorous, but it also needs to be relevant. You have heard that message time and time again: We have to find ways to streamline and modernize the FDA so that the United States can remain the leader in global medical innovation.

This package absolutely moves us closer to meeting all of those goals. These reforms will make the device approval process much more transparent, much more consistent, and much more predictable. And specifically, I'm happy that my provisions to streamline the third-party review process were included as well.

I want to thank the chairman and Members for their bipartisan support, and I urge the support of my colleagues.


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