US FDA admonishes GlaxoSmithKline, Astellas and Novartis for misleading drug promos

The US Food and Drug Administration has written to the local subsidiaries of European drug giants GlaxoSmithKline, Japan's Astellas and Novartis criticizing them for misleading promotion relating to GSK's cancer drug Arzerra (ofatumumab) in a journal advertisement, a web posting for Vesicare (solifenacin Succinate) and the Swiss firm's analgesic/pain gel Voltaren (diclofenac) in a consumer e-mail.

The FDA's Division of Drug Marketing, Advertising and Communications (DDMAC), having reviewed an advertisement for Arzerra in the Journal of Clinical Oncology, December 1, 2009, found it to be false or misleading because it omits important information about the drug's safety and effectiveness. Therefore, the ad misbrands Arzerra in violation of the Federal Food, Drug and Cosmetic Act. In addition, GSK published the ad within the first 120 days of marketing approval of Arzerra, which received accelerated approval under 21 CFR 601.41, but failed to submit a copy of this promotional ad to the FDA for consideration during the preapproval review period, as required by 21 CFR 601.45. Moreover, GSK failed to submit the ad to FDA under cover of Form FDA-2253, as required by 21 CFR 314.81(b)(3)(i). 'These violations concern us from a public health perspective because they suggest that Arzerra is more effective and safer than demonstrated,' the DDMAC letter to the company stated.

Misleading product claim