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Friday, April 16, 2010

FDA Haul Glaxo Over The Coals for Misleading Advertisement


Looks like Glaxo have been naughty again.

The standard 'Who's been naughty then?' type of letter has been sent to them by the American medicines regulator, the FDA.

In a letter to Philip A. Witman, GlaxoSmithKline's Associate Director of Global Regulatory Affairs, the FDA wrote:

Dear Mr. Witman:

The Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed a professional journal advertisement (AZA141R0 October 2009) (ad) for Arzerra™ (ofatumumab) Injection, for intravenous infusion (Arzerra) printed in the Journal of Clinical Oncology, Volume 27, No 34, dated December 1, 2009. The ad is 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, 21 U.S.C. 352(n) & 321(n), and FDA implementing regulations. 21 CFR 202.1(e)(1); (e)(5) & (e)(6)(i). In addition, GlaxoSmithKline (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 scathing letter to Witman continues with:

Misleading Product Claim Ad

While not mentioning Arzerra by name, the ad clearly points to the product, claiming that a “NEW Treatment Option for Refractory Chronic Lymphocytic Leukemia (CLL),” “*Refractory to fludarabine and alemtuzumab,” is “NOW APPROVED” and featuring GSK’s name and logo on the bottom of the ad. The characteristics of the product promoted in the ad can only describe Arzerra. Not only is Arzerra the only recently approved drug marketed by GSK for CLL, but no other product approved for the treatment of CLL has an indication that is limited to this specific population. Consequently, this presentation is a product-specific prescription drug ad for Arzerra. It is misleading because it omits material facts about the drug. The Arzerra ad also fails to include a true statement of information in brief summary relating to the side effects, contraindications (including warnings, precautions, etc.) and effectiveness of the drug (commonly referred to as the “brief summary”).

Specifically, the journal ad fails to reveal any of the risks associated with the use of Arzerra. By omitting the most serious and frequently occurring risks (see Background above), the journal ad suggests that Arzerra is safer than has been demonstrated by substantial evidence or substantial clinical experience

It has now been requested to GlaxoSmithKline that they immediately cease the dissemination of violative promotional materials for Arzerra.

The full letter can be downloaded HERE

Here is the ad that caused the stir.

Click on image to enlarge.

GlaxoSmithKline – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.



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