FDA Reviews Mailer from Millennium Pharmaceuticals for Velcade

ROCKVILLE, Md., June 24, 2009--The FDA posted on its website that it has reviewed a preASCO Donation Mailer (V0948) for Velcade® (bortezomib) for Injection (Velcade) submitted by Millennium Pharmaceuticals, Inc. According to the FDA, "This mailer is violative because although it has the form of reminder labeling, which is exempted by regulation from the requirements under the Federal Food, Drug, and Cosmetic Act (Act) for the disclosure of risk and other information, for the reasons set forth below, we have determined that your promotional material is not appropriate reminder labeling. In addition, this mailer is false or misleading because it overstates the efficacy of Velcade." Therefore, the mailer misbrands Velcade in violation of the Act, 21 U.S.C. 352(a) & 321(n), and FDA’s implementing regulations. 21 CFR 201.100(f) & 1.21; cf. 21 CFR 202.1(e)(3)(i), (e)(6)(i) & (e)(6)(xviii).

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM168731.pdf

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM168733.pdf

Posted: June 2009


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