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Public Statements

Food and Drug Administration Safety and Innovation Act

Floor Speech

Location: Washington, DC


Mr. ROBERTS. Madam President, I fear this legislation would insert Congress in the scientific process of approving applications that we have entrusted to the FDA. This application has been pending at FDA for over 15 years. We should allow the FDA to complete their scientific review of the product and not interfere with the ongoing reviews.

We have a science-based system that allows for complete review. We should allow that process to continue. This amendment sets up a two-tiered, two-agency approval system. That is not good. We know the FDA has already conferred with NOAA regarding the pending application.

Basically, Members of the Senate should not put on lab coats and tell the FDA to approve or deny the pending application. We should allow them to act on the statutory authority that is given to them. I reluctantly oppose the amendment of my colleague from Alaska.


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