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U.S. Department of Health and Human Services

About FDA

Total 2253 pieces (Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use) received

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.

Fiscal Year - 2010

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TimeTargetNumber
Oct 2009N/A7,523
Nov 2009N/A7,663
Dec 2009N/A6,433
Jan 2010N/A5,984
Feb 2010N/A5,717
Mar 2010N/A7,906
Apr 2010N/A6,828
May 2010N/A6,838
Jun 2010N/A7,412
Jul 2010N/A6,375
Aug 2010N/A6,431
Sep 2010N/A6,868

FY 2010 Total: 81,978

2253s segmented by promotion target: Percent of 2253s directed to Healthcare Professionals

Fiscal Year - 2010
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TimeTargetPercent
Oct 2009N/A71
Nov 2009N/A78
Dec 2009N/A72
Jan 2010N/A69
Feb 2010N/A74
Mar 2010N/A74
Apr 2010N/A77
May 2010N/A78
Jun 2010N/A80
Jul 2010N/A73
Aug 2010N/A71
Sep 2010N/A71

2253s segmented by promotion target: Percent of 2253s directed to Consumers

Fiscal Year - 2010
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TimeTargetPercent
Oct 2009N/A29
Nov 2009N/A22
Dec 2009N/A28
Jan 2010N/A31
Feb 2010N/A26
Mar 2010N/A26
Apr 2010N/A23
May 2010N/A22
Jun 2010N/A20
Jul 2010N/A27
Aug 2010N/A29
Sep 2010N/A29

2253s segmented by promotion channel: Percent of 2253s promoted using the Internet

Fiscal Year - 2010
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TimeTargetPercent
Oct 2009N/A17
Nov 2009N/A18
Dec 2009N/A26
Jan 2010N/A20
Feb 2010N/A20
Mar 2010N/A20
Apr 2010N/A20
May 2010N/A20
Jun 2010N/A23
Jul 2010N/A21
Aug 2010N/A24
Sep 2010N/A20

2253s segmented by promotion channel: Percent of 2253s promoted using non-Internet means (Print, TV etc.)

Fiscal Year - 2010
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TimeTargetPercent
Oct 2009N/A83
Nov 2009N/A82
Dec 2009N/A74
Jan 2010N/A80
Feb 2010N/A80
Mar 2010N/A80
Apr 2010N/A80
May 2010N/A80
Jun 2010N/A77
Jul 2010N/A79
Aug 2010N/A76
Sep 2010N/A80

Glossary

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.