CDER Ombudsman Contacts Fell By 25 Percent in 2017

CDER’s ombudsman heard from fewer whistleblowers and other external and internal contacts in 2017, according to the annual report released by the center.

Last year saw a total of 207 contacts compared to 289 in 2016 and the demographic categories that saw the biggest percentage drops were whistleblowers, which fell from 21 to 10, and investors, which fell from 16 to 2.

The most common reasons for contact from external parties were dispute resolution assistance, enquiries about CDER programs, policies or regulations, decision or response delays, reduced access to drugs because of an FDA regulatory action, and industry whistleblowers.

The majority of external contacts came from commercial industry, at 89, followed by law firms at 32, consumers at 11, whistleblowers at 10, consultants at eight and investors at two. Just over three quarters of communications were from external sources rather than internal ones.

The most common reasons for contact from FDA employees were for advice on issues such as managing contacts with external whistleblowers, responding to complaints or improving inter-Center collaboration.