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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 - 2011

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TimeTargetNumber
Oct 2010N/A6,294
Nov 2010N/A6,637
Dec 2010N/A6,089
Jan 2011N/A6,185
Feb 2011N/A5,796
Mar 2011N/A7,425
Apr 2011N/A6,919
May 2011N/A7,914
Jun 2011N/A7,726
Jul 2011N/A6,299
Aug 2011N/A6,971
Sep 2011N/A6,887

FY 2011 Total: 81,142

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

Fiscal Year - 2011
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TimeTargetPercent
Oct 2010N/A73
Nov 2010N/A76
Dec 2010N/A69
Jan 2011N/A70
Feb 2011N/A74
Mar 2011N/A82
Apr 2011N/A76
May 2011N/A76
Jun 2011N/A74
Jul 2011N/A68
Aug 2011N/A67
Sep 2011N/A69

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

Fiscal Year - 2011
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TimeTargetPercent
Oct 2010N/A27
Nov 2010N/A24
Dec 2010N/A31
Jan 2011N/A30
Feb 2011N/A26
Mar 2011N/A18
Apr 2011N/A24
May 2011N/A24
Jun 2011N/A26
Jul 2011N/A32
Aug 2011N/A33
Sep 2011N/A31

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

Fiscal Year - 2011
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TimeTargetPercent
Oct 2010N/A21
Nov 2010N/A23
Dec 2010N/A28
Jan 2011N/A26
Feb 2011N/A22
Mar 2011N/A22
Apr 2011N/A21
May 2011N/A20
Jun 2011N/A22
Jul 2011N/A24
Aug 2011N/A26
Sep 2011N/A26

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

Fiscal Year - 2011
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TimeTargetPercent
Oct 2010N/A79
Nov 2010N/A77
Dec 2010N/A72
Jan 2011N/A74
Feb 2011N/A78
Mar 2011N/A78
Apr 2011N/A79
May 2011N/A80
Jun 2011N/A78
Jul 2011N/A76
Aug 2011N/A74
Sep 2011N/A74

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.