Healthy Skepticism Library item: 17518

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

FDA Issues More Warning Letters Over Pharma Promotions
Pharma Live 2010 Mar 17
http://pharmalive.com/news/index.cfm?articleID=692068

Full text:

The FDA posted on its website, yesterday, warning letters sent to

Ista Pharmaceutics, Actavis and Sirion Therapeutics over promotional material. In the Actavis letter, the FDA criticized a Co-Pay Assistance Program brochure for Kadian calling it “false or misleading because they omit and minimize the serious risks associated with the drug.” In the Sirion letter it called a professional sales aid and a professional z-card for Durezol also “false and misleading.” A sales aid produced by Ista for Xibrom was also called “false or misleading .”
Ista Pharmaceuticals
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm204321.htm

Actavis
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm202644.htm

Sirion Therapeutics
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm202924.htm