CDER Ombudsman Releases Annual Report

May 15, 2012

The Center for Drug Evaluation and Research Ombudsman’s office released its annual report detailing the common questions and complaints received by the office in 2011. A total of 461 inquiries was received, an increase of 11% from 2010. The majority of inquiries, 60%, originated from industry, with consumers accounting for 23%, healthcare providers 7%, FDA employees 5%, and other 5%.

The most common questions and complaints received by the office regarded 510(k) submissions, adverse events and safety issues, drug applications, appeals processes, disputes of FDA-483 notices, and problems with the new electronic drug-registration process. Policies and procedures were listed as the number one reason the office was contacted.

The report cites a new trend in an increase in communications from small, emerging biotechnology and pharmaceutical companies, attributing the increase to smaller companies being less familiar with regulatory requirements and smaller companies having a financial need to resolve disputes quickly. Complaints about observations made on FDA-483s continued to be a trend from previous years.

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.