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Public Statements

Food and Drug Administration Safety and Innovation Act

Floor Speech

By:
Date:
Location: Washington, DC

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Mrs. MYRICK. Thank you, Mr. Chairman.

The bill before us contains critical improvements to the current law. Among them is the creation of a priority review voucher program for companies that develop treatments for rare pediatric diseases. I am pleased with this and other advances.

Yet the long-term success or failure of crucial drug and device approvals doesn't just depend on approving new funds and guidelines for the FDA. It also depends on instilling a culture at the FDA that seeks out practical solutions to the diseases that our constituents face. The FDA must recognize that patients, especially those with fatal illnesses, deserve to have potential treatments made available.

Whenever possible, the FDA should use all the tools it has available to appropriately warn doctors and patients of risks associated with a treatment without removing patient access. Patients facing fatal diagnoses, whether it's metastatic cancer, ALS or others, should be given the benefit of the doubt unless treatments are very risky. This should be a guiding principle of the FDA and not simply a consideration.

I urge the support of the bill.

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