GSK Awareness Ad for Arzerra a "Stealth Product Promotion," Says FDA | Pharma Industry Regulation |

In 2010, FDA scolded GlaxoSmithKline over a disease-awareness ad that failed to mention side effects but alluded to newly approved cancer treatment Arzerra.

The violation, communicated by the FDA through an untitled letter, raised eyebrows in legal circles, since disease-awareness communications typically are not subject to side-effect disclosure requirements. “The implications of that letter here are that [FDA is] going to construe the disease-awareness exception very narrowly,” said Arnold Friede, a former top Pfizer lawyer and expert on FDA law. “It also reflects their desire to stake out a broad scope for their authority.”

There are circumstances in which FDA will treat a supposed disease-awareness piece as conventional branded advertising. One is if FDA determines that a supposed disease-awareness ad “impliedly identifies a particular drug or device.” This may be the case when a communication relates to a drug that is the only product in its diagnostic or therapeutic class.

The ad for Arzerra (ofatumumab) targeted healthcare professionals, running in the December 1, 2009, issue of Journal of Clinical Oncology. Without identifying Arzerra explicitly, the ad mentions the availability of a new drug for adult chronic lymphocytic leukemia (CLL) that is resistant to fludarabine and alemtuzumab and features the GSK logo at the bottom.

As to why the ad was considered promotional, the FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) stated in the letter, “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.” Arzerra was approved in October and launched in mid-November.

“Consequently,” DDMAC added, “this presentation is a product-specific prescription drug ad for Arzerra” and is subject to disclosure of warnings and precautions related to infusion reactions, among others, as well as common adverse reactions, including pneumonia, cough and diarrhea, among many others. GSK was also cited for not submitting the ad for DDMAC review prior to being published.