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Senate Passes Hagan Legislation as Part of FDA Overhaul Bill

Press Release

Location: Washington, DC

U.S. Senator Kay R. Hagan (NC) today praised passage of the bipartisan Food and Drug Administration Safety and Innovation Act. Central to this FDA overhaul bill are key provisions of the TREAT Act, or the Transforming the Regulatory Environment to Accelerate Access to Treatments Act, which Hagan introduced in February. The FDA Safety and Innovation Act passed the Senate by a vote of 96 to 1.

"The TREAT Act brings hope to patients in North Carolina and around the country," said Hagan, a member of the Senate Health Education Labor and Pensions Committee. "My legislation establishes a clear and effective pathway for turning ideas into cures, and cures into treatments, for patients suffering from serious, rare and life-threatening diseases. We've taken a big step today in finding cures and saving lives."

The provisions of Senator Hagan's TREAT Act will expedite the review of treatments for serious, rare and life-threatening diseases, without compromising the FDA's high standards for safety and effectiveness. These provisions will also help the FDA to assist drug sponsors navigating the approval process.

The FDA Safety and Innovation Act is also imperative for creating jobs in states like North Carolina and maintaining America's competitive edge in the global economy. The bill provides the necessary regulatory updates to keep pace with the rapid innovations of the pharmaceutical and biopharmaceutical industries. North Carolina's biopharmaceutical and medical technology industries support an estimated 140,000 direct and indirect jobs and contribute over $30 billion dollars to the economy. Pharmaceutical, biotech and medical technology companies are partnering with North Carolina's world-class universities to create jobs and improve the health of people all across the globe.

Earlier today, Senator Hagan spoke on the Senate floor urging her colleagues to support the passage of this bill.

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