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Waxman and Kennedy Request GAO Examination of FDA Resource Shortfalls

From the Oversight Committee:

Waxman and Kennedy Request GAO Examination of FDA Resource Shortfalls

WASHINGTON, DC — Today Rep. Henry A. Waxman and Sen. Edward M. Kennedy wrote to Comptroller General of the United States David Walker requesting an examination of the staffing, information technology, and other resources necessary for the Food and Drug Administration (FDA) to successfully carry out its oversight of foods, drugs, biologics, and medical devices.

FDA is responsible for ensuring the safety and effectiveness of a wide range of consumer products, including 80% of the nation's food supply, and human and veterinary drugs, biological products, medical devices, cosmetics, and products that emit radiation. These enormous responsibilities have major implications for the health, safety, and well-being of all Americans.

FDA's Science Board recently concluded that “FDA can no longer fulfill its mission without substantial and sustained additional appropriations.” As demands increase on the agency, FDA’s budget has declined in real terms. In recent years, its annual budget requests have not covered its own needs, its annual appropriations have not kept pace with inflation, and the agency has become increasingly dependent on user fees. Additionally, FDA appears to lack enough personnel that possess the sets of skills necessary to meet the increasing demands on the agency.

“Although our government always faces financial constraints, we cannot afford to put FDA, which performs tasks vital to the public health, in a situation in which it cannot succeed,” said Rep. Waxman and Sen. Kennedy in the letter to Mr. Walker. “We know that we are not alone in our concern. Public confidence in FDA, and the foods and medical products it regulates, is waning.”

Read the full letter (pdf) >>

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