Healthy Skepticism Library item: 17832
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 Sends Amgen Letter Regarding Vectibix Oral Statements
Pharma Live 2010 May 26
http://pharmalive.com/news/index.cfm?articleID=707267&
Notes:
Link to FDA letter:
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM213379.pdf
Full text:
The FDA posted on its website a letter sent to Amgen about oral statements a company represenative made at a medical conference regarding the company’s cancer drug, Vectibix. According to the FDA letter, “The representative’s oral statements are false or misleading because they make misleading comparative claims, promote an unapproved use, minimize serious risks associated with Vectibix, and omit material facts about the use of the drug.”
