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Report faults FDA data on staff's outside work


WASHINGTON -- Nearly all senior staff members of the Food and Drug Administration who sought permission to consult, lecture or perform other activities outside the agency from 2000 to 2003 filed incomplete applications, making it difficult to determine whether the work created conflicts of interest, according to a government review released yesterday.

The agency approved almost half the applications after the activities had begun, said the report by the Department of Health and Human Services inspector general.

"The extent and frequency of these deficiencies in the forms we reviewed raise systemic concerns about how FDA collects and reviews information regarding employee's outside activities," said the 60-page report.

Senior officials provided short or vague answers on applications or didn't describe in sufficient detail the nature of the outside work, the report said. Also, senior officials failed to report their outside activities on annual financial disclosure forms almost half of the time.

The review was requested by members of the House Energy and Commerce Committee, which oversees the FDA.

FDA employees are permitted to teach, write and perform other outside work after filing an application and receiving approval. From 2000 to 2003, the years studied by the inspector general, 23 of 90 senior senior staff received formal permission. Most had one or two outside activities, and most were not paid, the review said.

Dr. Andrew C. von Eschenbach, FDA's acting commissioner, wrote in response that the agency has taken steps to address the deficiencies. FDA has revised its permission form, he said, and now makes sure senior officials report any outside work on financial disclosure forms.

The agency is also writing new policies, automating its application system and developing new ethics training, he said.

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