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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.

• FY 2010
• FY 2011
• FY 2012
• All

Percentage of complaint letters reviewed within 30 days

Fiscal Year - 2010

Time	Target	Percent
Oct 2009	N/A	88
Nov 2009	N/A	60
Dec 2009	N/A	55
Jan 2010	N/A	50
Feb 2010	N/A	80
Mar 2010	N/A	81
Apr 2010	N/A	88
May 2010	N/A	100
Jun 2010	N/A	94
Jul 2010	N/A	100
Aug 2010	N/A	100
Sep 2010	N/A	89

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

Fiscal Year - 2010

Time	Target	Percent
Oct 2009	N/A	100
Nov 2009	N/A	80
Dec 2009	N/A	91
Jan 2010	N/A	67
Feb 2010	N/A	80
Mar 2010	N/A	88
Apr 2010	N/A	88
May 2010	N/A	64
Jun 2010	N/A	94
Jul 2010	N/A	93
Aug 2010	N/A	70
Sep 2010	N/A	78