James M. Jeffords: “Mr. President, today, we move forward again on the motion to proceed with respect to the reform of the FDA bill, S. 830.…”

“Mr. President, today, we move forward again on the motion to proceed with respect to the reform of the FDA bill, S. 830. Under the Federal Food, Drug, and Cosmetic Act, Food and Drug Administration commonly known as FDA, has two important functions: First, the review and approval of important new products that can improve the public health, such as lifesaving drugs, biological products, and medical devices; and second, the prevention of harm to the public from marketed products that are unsafe or ineffective. Since 1938, the Federal Food, Drug, and Cosmetic Act has been amended numerous times to expand the FDA's mission to ensure that only safe or ineffective products are marketed. But the act has been changed only once, by the Prescription Drug User Fee Act of 1992, commonly called PDUFA, to strengthen the FDA's ability to review and approve expeditiously important new products that can improve the public health. Food and Drug Administration Modernization and Accountability Act of 1997, S. 830, is designed to ensure the timely availability of safe and effective new products that will benefit the public and to ensure that our Nation continues to lead the world in new product innovation and development.”