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Public Statements

Food and Drug Administration Reform Act of 2012

Floor Speech

Location: Washington, DC


Mrs. CAPPS. I thank my colleague for yielding me time.

I rise today in strong support of the FDA Reform Act of 2012. I must say it is an honor to associate myself with the remarks of our chairman emeritus, Mr. Dingell, who worked tirelessly over the years with regard to the Food and Drug Administration in making it a good institution that can only become better.

This bill represents the spirit of compromise--compromise across the aisle and also among the many stakeholders that work toward innovations to improve our health. It demonstrates that at a time when most of the country believes that we in Congress can't work together at all or pass a piece of legislation without a long and bitter fight, we can come together to improve health, protect the safety of the American people and, at the same time, to support good jobs and innovation in our health care industry.

I am especially pleased that two of my provisions have been included in this legislation. For example, the SAFE Devices Act will improve the postmarket surveillance of medical devices and the implementation of the unique device identifier program. This is an essential provision that will let us know that our devices work, and it will allow us to identify potential problems early on, protecting patients and identifying issues when they are easier and less costly to address. Additionally, the bill includes the simplification of FDA's de novo process--an important step to helping both medical devices manufacturers and patients.

I thank Chairmen UPTON and PITTS and Ranking Members PALLONE and WAXMAN for their leadership on this bill. I also thank the numerous advocates, the many patients and other stakeholders who came together and contributed to this bill so that it would come to fruition today.

Of course, there is more work in front of us that remains to be done, but this bill before us is an important step in ensuring that our drug and device pipelines continue to produce needed cures and treatments in order to keep us all healthy, which is why I urge my colleagues to support it.


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