FDA Drug Evaluation Ombuds Issues Annual Report

Virginia L. Behr, the Ombuds for the Food and Drug Administration Center for Drug Evaluation and Research, has issued her report for 2008. Drawing on practices from IOA, USOA and COFO, the CDER Ombuds works to informally resolve complaints from the regulated pharmaceutical industry, consumers and FDA employees. In 2008, Behr’s office received 833 communications, a 26% increase from the prior year, although most of the increase was due to a coordinated campaign by consumers seeking approval of a specific drug. In 2008, the CDER Ombuds Office transferred some responsibilities to a newly hired Product Jurisdiction Officer. (CDER Ombuds 2008 Report.)