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Office of Prescription Drug Promotion (OPDP) Metrics

Office of Prescription Drug Promotion (OPDP) Metrics

Number of core initial promotional campaign material reviews completed in the month

Dictionary: “Launch” materials are the initial promotional materials that companies disseminate to healthcare professionals and consumers after FDA approves a new drug (or approves a new use for a drug). FDA believes it is critically important to ensure that the promotional messages companies use to introduce new drugs are accurate and balanced as these messages form the public’s first impression of new drugs. The “core” launch materials are those that contain the key messages that will be used throughout the launch campaign, as well as representative examples of other important disclosures, such as risk information, for the advertised product. By reviewing and providing advisory comments on core launch campaigns in a timely manner, OPDP can positively influence the initial marketing messages that companies disseminate about their new products and help ensure that the public receives accurate and balanced information about new prescription drugs. Because this is a program measure (i.e., a measure that focuses on the OPDP program area), the time required for consultation outside of OPDP (if any) on launch campaigns is being subtracted out of the overall review time. As a result, the measure is reflective of the time it takes to review these materials within OPDP rather than the total agency review time.

Completed Core Launch Reviews in 45 days
 Time  Number
 Oct 2018  5
 Nov 2018  5
 Dec 2018  5
 Jan 2019  3
 Feb 2019  1
 Mar 2019  6
 Apr 2019  
 May 2019  
 Jun 2019  
 Jul 2019  
 Aug 2019  
 Sep 2019  

FY 2019 YTD: 25

Percent Completed Core Launch Reviews in 45 days
 Time  Number
 Oct 2018  63
 Nov 2018  71
 Dec 2018  100
 Jan 2019  60
 Feb 2019  25
 Mar 2019  86
 Apr 2019  
 May 2019  
 Jun 2019  
 Jul 2019  
 Aug 2019  
 Sep 2019  

FY 2019 YTD: 67
FY 2018

*Footnotes

The FDA’s goal is to provide comments on draft “core launch” promotional materials within 45 days of the voluntary submission of these materials by sponsors. However, some recent draft core launch promotional materials submitted for voluntary review have raised complex issues that required additional review, resulting in review times that exceeded the 45 day goal. While review timeframes for certain submissions may require more than 45 days in the immediate future, the FDA is working hard to review the majority of submissions within 45 days and to achieve overall completion percentages that are similar to those observed in the past. Sponsors are encouraged to contact the FDA with any questions and to temporarily build in additional review time for their materials.

Percentage of complaints preliminarily reviewed and acknowledged within 30 days of receipt

Dictionary:  OPDP receives complaints regarding potentially false or misleading promotion from health care professionals, consumers, drug sponsors, and law firms.  OPDP's goal is to acknowledge receipt of these complaints within 30 calendar days.

Complaints Acknowledged in 30 days
 Time  Number
 Oct 2018  12
 Nov 2018  10
 Dec 2018  4
 Jan 2019  3
 Feb 2019  13
 Mar 2019  7
 Apr 2019  
 May 2019  
 Jun 2019  
 Jul 2019  
 Aug 2019  
 Sep 2019  

FY 2019 YTD: 49

 

Percentage Complaints Acknowledged in 30 days
 Time  Number
 Oct 2018  100
 Nov 2018  100
 Dec 2018  100
 Jan 2019  100
 Feb 2019  85
 Mar 2019  86
 Apr 2019  
 May 2019  
 Jun 2019  
 Jul 2019  
 Aug 2019  
 Sep 2019  

FY 2019 YTD: 94
FY 2018

 

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