Dictionary: OPDP tracks the incoming volume of prescription drug promotional pieces that it receives each month. Companies are required to submit copies of the pieces they develop to promote their prescription drugs on Form FDA-2253 at the time these pieces are first publicly used (these submissions are referred to as “2253” submissions). OPDP monitors incoming 2253 submissions to examine trends in prescription drug promotion both by promotion target (e.g., consumers versus healthcare professionals) and by channel (e.g., print, broadcast, internet). For example, in recent years OPDP has seen a large increase in the volume of 2253 submissions that are internet-based, and this is one of the trends it is tracking under Measure B. This measure also provides a surrogate measure of OPDP’s potential workload by capturing the total amount of prescription drug promotion that is developed and disseminated during given periods of time; as such, it is useful to monitor to help ensure the efficient allocation of review resources within OPDP.
These measures have been retired as CDER has created new measures for FY13 which align to their four functional areas of 1) Regulatory Review and Drug Safety, 2) Drug Quality and Compliance, 3) Transparency and Public Outreach, and 4) Regulatory Science Research.
Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.
