There’s no question that direct-to-consumer (DTC) advertising of prescription drugs is a huge activity, with nearly $5 billion spent on DTC ads in 2007. There’s also no question that the Internet has a vast potential to reach consumers. But when you put DTC advertising and the Internet together, there is a potential for problems and miscommunications.
Novartis recently received a warning letter from the U.S. Food and Drug Administration (FDA) for its online advertising of a leukemia drug. The situation could serve as a benchmark for future advertising of medications for rheumatologic conditions—and a cautionary tale for pharmaceutical companies and physicians alike.
The U.S. website for the drug nilotinib 200 mg (Tasigna) included a Facebook share “widget”—a small application that Facebook users can click on to share content about that particular website with others on Facebook. The problem was that, when users clicked on the Facebook share widget for Tasigna, no information was conveyed about the drug’s related risks. Additionally, “… the shared content inadequately communicates Tasigna’s FDA-approved indication and implies superiority over other products,” according to a July letter to Novartis from Karen R. Rulli, PhD, acting group leader of the FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC). The lack of information and purported misinformation violated certain FDA regulations, and Dr. Rulli requested that Novartis cease dissemination of the “violative” promotional materials.
“Novartis takes the letter issued by the FDA very seriously, and we have addressed its concerns by taking the direct and immediate action of taking down the widget referenced by the FDA,” reports a Novartis spokesperson. “Novartis will continue to have active discussions with the FDA to understand fully all of the concerns. We also will assess all of our Web assets and materials based on these concerns.”
A person who has fibromyalgia may want to know about Humira … because their cousin sent them a Facebook feed for it.
—John J. Cush, MD
Broader Implications
Although the fix for Novartis may have been easy, the FDA’s actions come at a time when many in industry want and anticipate further guidance from the agency regarding online promotion of prescription drugs. The FDA held a public hearing late last year regarding promotion of FDA-regulated medical products via the Internet and social media such as Facebook and Twitter. Leaders at DDMAC are working on multiple draft guidances related to this issue, with the goal that at least one to be issued by the end of this year, says FDA spokeswoman Crystal Rice. She could not comment as to when specifically any of the draft guidances would be issued.
