Document Detail

FDA actions against health economic promotions, 2002-2011.
MedLine Citation:
PMID:  22999146     Owner:  NLM     Status:  In-Data-Review    
OBJECTIVE: To investigate Food and Drug Administration (FDA) regulatory actions against drug companies' health economic promotions from 2002 through 2011 to understand how frequently and in what circumstances the agency has considered such promotions false or misleading.
METHODS: We reviewed all warning letters and notices of violation ("untitled letters") issued by the FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) to pharmaceutical companies from January 2002 through December 2011. We analyzed letters containing a violation related to "health economic promotion," defined according to one of several categories (e.g., implied claims of cost savings due to work productivity or economic claims containing unsupported statements about effectiveness or safety). We also collected information on factors such as the indication and type of media involved and whether the letter referenced Section 114 of the Food and Drug Administration Modernization Act.
RESULTS: Of 291 DDMAC letters sent to pharmaceutical companies during the study period, 35 (12%) cited a health economic violation. The most common type of violation cited was an implied claim of cost savings due to work productivity or functioning (found in 20 letters) and economic claims containing unsubstantiated comparative claims of effectiveness, safety, or interchangeability (7 letters). The violations covered various indications, mostly commonly psychiatric disorders (6 letters) and pain (6 letters). No DDMAC letter pertained to Food and Drug Administration Modernization Act Section 114.
CONCLUSION: The FDA has cited inappropriate health economic promotions in roughly 12% of the letters issued by the DDMAC. The letters highlight drug companies' interest in promoting the value of their products and the FDA's concerns in certain cases about the lack of supporting evidence.
Peter J Neumann; Sarah K Bliss
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Publication Detail:
Type:  Journal Article     Date:  2012-06-15
Journal Detail:
Title:  Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research     Volume:  15     ISSN:  1524-4733     ISO Abbreviation:  Value Health     Publication Date:  2012 Sep 
Date Detail:
Created Date:  2012-09-24     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100883818     Medline TA:  Value Health     Country:  United States    
Other Details:
Languages:  eng     Pagination:  948-53     Citation Subset:  IM    
Copyright Information:
Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.
Center for the Evaluation of Value and Risk in Health, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts. Electronic address:
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