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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 - 2010

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TimeTargetNumber
Oct 2009N/A8
Nov 2009N/A5
Dec 2009N/A11
Jan 2010N/A6
Feb 2010N/A5
Mar 2010N/A16
Apr 2010N/A8
May 2010N/A22
Jun 2010N/A16
Jul 2010N/A15
Aug 2010N/A20
Sep 2010N/A9

FY 2010 Total: 141

Percentage of complaint letters reviewed within 30 days

Fiscal Year - 2010
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TimeTargetPercent
Oct 2009N/A88
Nov 2009N/A60
Dec 2009N/A55
Jan 2010N/A50
Feb 2010N/A80
Mar 2010N/A81
Apr 2010N/A88
May 2010N/A100
Jun 2010N/A94
Jul 2010N/A100
Aug 2010N/A100
Sep 2010N/A89

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

Fiscal Year - 2010
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TimeTargetPercent
Oct 2009N/A100
Nov 2009N/A80
Dec 2009N/A91
Jan 2010N/A67
Feb 2010N/A80
Mar 2010N/A88
Apr 2010N/A88
May 2010N/A64
Jun 2010N/A94
Jul 2010N/A93
Aug 2010N/A70
Sep 2010N/A78

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.