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Public Statements

Food and Drug Administration Safety and Innovation Act

Floor Speech

Location: Washington, DC


Mr. GUTHRIE. Mr. Speaker, I appreciate the gentleman for yielding.

I rise today in support of the legislation to reauthorize the Prescription Drug and Medical Device User Fee Act and authorize new user fee programs for generic drugs and biosimilars. The legislation also includes important reforms to grant patients improved access to new therapies and promotes innovation and job creation.

Jobs and the economy are top issues for most Americans, and this bill focuses on that. As a manufacturer, I've heard many stories from many device manufacturers across the country about problems they face with the FDA and how those struggles are making it harder for them to manufacture in America.

This bill includes important changes, including one that I championed, to reform the FDA's guidance process that will inject certainty into the process and create more American jobs.

This bill is an example of working in a bipartisan way to achieve a quality product that creates jobs. I thank the chairman and the ranking member for their work. And, Mr. Speaker, I urge my colleagues to support this bill.


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