Mike Enzi: “as we move to a vote on the nomination of Dr. Lester Crawford to serve as Commissioner of Food and Drugs, I want to…”

“as we move to a vote on the nomination of Dr. Lester Crawford to serve as Commissioner of Food and Drugs, I want to remind my colleagues of the important role the Food and Drug Administration plays in protecting and promoting the public health. The FDA's mission is broad. The FDA regulates food, drugs, biologics, medical devices, animal feed, and cosmetics. The FDA regulates everything from cellular phones to cell tissue and gene therapies. In fact, Americans spend more than 25 cents of every dollar on products regulated by the FDA. And as science progresses, the challenges of regulation grow. For instance, the FDA regulates a host of new products that blur the FDA's traditional boundaries. Today, the FDA is charged with regulating drug- delivery devices, such as coronary stents coated with drugs that contribute to keeping arteries open. Then there are next- generation orthopedic implants with biologic products built into them to stimulate tissue growth. All of these new innovations require a nimble and responsive agency to regulate them, and they require resources to match. Today, in fact, Senator Kennedy and I are introducing legislation to protect and strengthen a critical user-fee program. This program provides FDA with a stable stream of revenues to support the agency's mission to review and approve new medical devices. Without our action, that program would expire at the end of this fiscal year.…”