May 30, 2012

FDA Center for Drug Evaluation and Research Ombuds Reports 11% Jump in Cases

Virginia L. Behr, the Ombudsman for the Food and Drug Administration Center for Drug Evaluation and Research, says that her office handled 461 inquiries in 2011. The majority of inquiries, 60%, originated from industry, with consumers accounting for 23%, healthcare providers 7%, FDA employees 5%, and other 5%. 

 The CDER Ombudsman is an independent public official that works to informally resolve questions, complaints, and comments the office receives from a variety of areas of the pharmaceutical industry, including advocacy groups, research institutions, consumers, healthcare providers, and FDA employees. The CDER Ombudsman follows a code of ethics and operating principles drawn from those established by the Coalition of Federal Ombudsmen, the United States Ombudsman Association, and IOA. (CDER Ombuds 2011 Annual Report.)

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