Jack Reed: “I rise today to address S. 830, the Food and Drug Administration Modernization and Accountability Act of 1997. This is…”

“I rise today to address S. 830, the Food and Drug Administration Modernization and Accountability Act of 1997. This is an important bill with serious implications for the health of the American people. The FDA is responsible for assuring that the Nation's food supply is pure and healthy as well as providing a guarantee that drugs and medical devices are safe and effective. The FDA has an immense impact on the lives of all Americans. Few government agencies provide this kind of important protection for the American people. Indeed, the FDA's mandate requires it to regulate over one-third of our Nation's products. Daily, the FDA faces the delicate balance between ensuring that patients have swift access to new drugs and devices, while guaranteeing that those new products are safe and effective. S. 830 contains many positive elements. It reauthorizes the important Prescription Drug User Fee Act, one of the most effective regulatory reforms ever enacted. S. 830 also includes a number of provisions that will improve and sensibly streamline the regulation of prescription drugs, biologic products, and medical devices. I believe that these important reforms to the operation of the Food and Drug Administration will increase its efficiency and speed the delivery of important new medical treatments to patients.”