DDMAC Says GSK Ad Is Branded Even Without Mention Of Drug Name

The journal ad promoted a new treatment for refractory chronic lymphocytic leukemia, but DDMAC said it was obviously Arzerra. This isn't GSK's first time with this problem.

FDA's determination that a journal ad was clearly a promotion for GlaxoSmithKline's Arzerra even though it did not specifically mention the drug elicited a citation from the Division of Drug Marketing, Advertising and Communications.

The ad, which appeared in the Dec. 1, 2009 edition of the Journal of Clinical Oncology, did not specifically name GlaxoSmithKline's Arzerra (ofatumumab). It referred to a new treatment option for CLL that has been approved, but the only product it could be describing was Arzerra, FDA said. The ad also had the GSK name and logo at the bottom, further evidence the company was promoting the drug.

"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," DDMAC stated in the letter. Ofatumumab was approved by FDA Oct. 26, 2009 for treatment for chronic lymphocytic leukemia that does not respond to fludarabine and alemtuzumab.

"The characteristics of the product promoted in the ad can only describe Arzerra," the letter concludes.

GSK was cited for a similar problem in a 2006 warning letter, when a deck card intended as a sexually-transmitted disease awareness piece was ruled a promotion for the company's Zovirax (acyclovir) genital herpes ointment (Also see "GSK/Biovail Zovirax Ads Are Target Of Warning Letter" - Pink Sheet, 5 Jul, 2006.).

The deck card gave information on genital herpes and included the Zovirax website address on the front and back. DDMAC determined that including the website name with disease information made the card a full product piece that did not have the necessary risk or indication information. The product label, which was printed on the inside of the card, was accessible only if the card was dismantled, the agency said.

Ad Fails To Meet Requirements For Product-Specific Piece

Once FDA determined that the journal ad was in fact a product-specific promotion for Arzerra, it found it lacking on all major fronts, as the ad was designed to be an unbranded piece.

It does not include any risk information, and "fails to communicate the indication for Arzerra, including limitations to the efficacy data that supported the product's approval and limitations to the indication," the letter states. Thus the ad overstates the efficacy, the letter charges.

Along the same vein, because the journal ad did not include information about the typical and most serious risks of CLL or any of the risks associated with Arzerra, DDMAC decided it made false safety claims.

There is a link for more information on www.cllinformation.com, a website that directs to the Arzerra labeling, but FDA determined that "this does not substitute as a brief summary for the journal ad, or mitigate the misleading omission of material information from the ad."

GSK also was cited for not submitting the journal ad to FDA, as required for product-specific promotions, through the form 2253 process and for not submitting during the 120-day preapproval review period.

The firm was told to stop using the ad and must respond to the untitled letter by April 29. The company said it would stop using the ad and was working to resolve any remaining FDA questions.

The letter was issued April 15, just days before GSK announced April 19 it had received conditional marketing authorization for Arzerra as a treatment for CLL from the European Commission.

-Derrick Gingery ([email protected])