Healthy Skepticism Library item: 17265

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 Informs Eisai Medical Research on 'Misleading' Aricept TV Ads
PharmaLive 2009 Feb 18
http://pharmalive.com/news/index.cfm?articleID=686267

Notes:

Link to letter: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM201238.pdf

Link to promotional material: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM201240.pdf

Full text:

The FDA has posted on its website a letter regarding two television ads for the Alzheimer’s disease drug

Aricept. The agency said the ads are misleading because they overstate the drug’s efficacy. The links to the letter and promotional material are below.

A letter from FDA’s DDMAC was posted on the agency’s website calling television ads for Alzheimer’s treatment Aricept
‘misleading’ because it overstates the efficacy of the drug. The FDA said one study indicated “that less than 5% of
patients treated with Aricept at either dose were ‘markedly improved’ or ‘moderately improved’.” The ads in question
involve a beach scene and a garden scene.