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FDA's Mission Has Been Compromised, GAO Healthcare Director Says
According to Marcia Crosse (Director, Health Care at GAO), FDA's ability to fulfill its mission to protect American health has been compromised. In her comments on why oversight of medical devices was placed on GAO's High-Risk List, she says:
"The Food and Drug Administration plays a key role in protecting the health of all Americans. FDA's role is far-reaching: from over-the-counter pain relievers to vaccines to prescription drugs to every medical device in your doctor's office or your local hospital. FDA is responsible for assuring the safety and effectiveness of every medical product before it is approved. After approval, FDA has a duty to ensure the continuing safety of hundreds of thousands of different medical products, regardless of whether they are manufactured here or abroad, and more than eight million shipments of medical products arrive at US ports in a single year. But, FDA is having difficulties in meeting its responsibilities."
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