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U.S. Department of Health and Human Services

About FDA

Total number of complaint letters regarding promotion materials reviewed in the month

Dictionary: OPDP is tracking the number of complaint letters regarding prescription drug promotion that it receives and reviews each month. OPDP’s objective is to review and acknowledge complaint letters within 30 days of their receipt and to further investigate complaints that appear to have merit. Complaint letters aid in the discovery of illegal promotional activities; the prompt review and acknowledgement of complaints will help encourage the submission of further valuable information by complainants. This in turn can serve as the first step in the action needed to identify and stop future misleading promotion.


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/A12
Nov 2010N/A13
Dec 2010N/A8
Jan 2011N/A7
Feb 2011N/A7
Mar 2011N/A10
Apr 2011N/A12
May 2011N/A16
Jun 2011N/A6
Jul 2011N/A8
Aug 2011N/A11
Sep 2011N/A7

FY 2011 Total: 117

Percentage of complaint letters reviewed within 30 days

Fiscal Year - 2011
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TimeTargetPercent
Oct 2010N/A100
Nov 2010N/A100
Dec 2010N/A100
Jan 2011N/A100
Feb 2011N/A100
Mar 2011N/A100
Apr 2011N/A100
May 2011N/A100
Jun 2011N/A100
Jul 2011N/A100
Aug 2011N/A100
Sep 2011N/A100

Percentage of complaint letters reviewed in the month appearing to have merit

Fiscal Year - 2011
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TimeTargetPercent
Oct 2010N/A75
Nov 2010N/A93
Dec 2010N/A75
Jan 2011N/A100
Feb 2011N/A86
Mar 2011N/A70
Apr 2011N/A83
May 2011N/A73
Jun 2011N/A83
Jul 2011N/A63
Aug 2011N/A73
Sep 2011N/A86

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.