Food and Drug Administration Safety and Innovation Act

Floor Speech

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Mr. BURGESS. I thank the chairman for yielding and the Speaker for the recognition.

Today, we are considering the Food and Drug Administration's Safety Innovation Act, and I urge my colleagues to support it. This bill reauthorizes Food and Drug Administration's user fee programs. The bill will allow industry to continue to partner in providing our physicians the tools they need to prevent and alleviate human suffering.

The legislation retains significant reforms that were made in our House bill and enhances other provisions, such as those on drug shortages. The bill will ensure that the Food and Drug Administration has the scientific and medical expertise they need when reviewing products utilizing emerging science, or for those populations with very rare diseases.

This bill will spur innovation for antibiotics, will help those with rare diseases, and be particularly helpful to the community of physicians that takes care of our pediatric cancer patients.

The Food and Drug Administration is now required to notify Congress before issuing guidance regarding the regulation of laboratory-developed tests. I still believe we should strengthen and improve CLIA's oversight of laboratory-developed tests, instead of even contemplating any type of duplicative regulation.

The bill avoids provisions added by the other Chamber that I thought crossed the line into the practice of medicine by Congress and actually threatened patient treatment. It will address numerous other issues to enhance the work of the FDA, while correcting missteps of the Agency in such areas as public input, good guidance practices, and the manufacture of custom devices.

The process to this vote from the very beginning was respectful and resulted from hundreds of hours of negotiations. Chairman Upton, thank you, and Chairman Pitts, Ranking Members WAXMAN and PALLONE. I specifically want to thank Ryan Long and Clay Alspach on the staff of the majority who sacrificed much to get this product to the floor today.

This vote is really about patients who will be served by the passage of this bill, and I urge its expeditious passage.

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