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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 - 2012

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TimeTargetNumber
Oct 2011N/A7
Nov 2011N/A16
Dec 2011N/A6
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

FY 2012 YTD: 29

Percentage of complaint letters reviewed within 30 days

Fiscal Year - 2012
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TimeTargetPercent
Oct 2011N/A100
Nov 2011N/A94
Dec 2011N/A100
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

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

Fiscal Year - 2012
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TimeTargetPercent
Oct 2011N/A71
Nov 2011N/A81
Dec 2011N/A67
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

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.