June 04, 2008

FDA Ombuds Issues Annual Report

The FDA's Center for Drug Evaluation and Research Ombuds Office has issued a report summarizing its activities in 2007. In total, the CDER Ombuds received 660 communications, the vast majority of which came via electronic mail and phone. Half of the contacts came from the pharmaceutical industry and researchers, 40% from consumers and health care professionals, and 10% from CDER employees. The report also marked the retirement of Warren Rumble, who served as the CDER Ombuds since 2001, and the appointment of Virginia L. Behr.

Although the job posting for the CDER Ombuds position seemed in conflict with IOA and USOA standards, the CDER Ombuds Annual Report specifically states:
The CDER Ombudsman’s Office draws its ethical principles and standards from those established by the Coalition of Federal Ombudsmen, USOA, and the International Ombudsman Association. These include standards for ensuring confidentiality, neutrality, independence, a credible review process, and informality. The Office reports to the Director of the Office of Executive Programs within the Office of the Center Director. The Ombudsman is a member of the Coalition of Federal Ombudsmen.

This is a notable change from the prior five annual reports, which stated that the CDER Ombuds was "a member of the Coalition of Federal Ombudsmen, and the American Association of Ombudsmen." Whatever that is. (FDA CDER Ombuds Report.)

Prior: Job Posting.

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