CDER Ombudsman Releases Annual Report

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.