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.
This situation has broad implications for all medical specialties, but carries some particular concerns for rheumatology, experts say.
First, advertising via the Internet and social media does not have the same level of control as advertising via print media, television, or radio, where there is a more targeted audience, says Lenore Buckley, MD, professor of internal medicine in the division of rheumatology, allergy, and immunology at Virginia Commonwealth University in Richmond. Dr. Buckley previously served on an FDA advisory committee on arthritis drugs and is a member of the ACR Drug Safety Committee. “The promotions can be disseminated much more quickly to wider audiences, and this is a more difficult media for the FDA to monitor,” she says.
“The target is everything and everyone,” says John J. Cush, MD, director of clinical rheumatology at Baylor Research Institute in Dallas. Dr. Cush has also worked with FDA advisory committees. “You can say you’re going to send something to 1,600 people, but where it goes after that is totally out of your control.” This could make it more difficult to ensure that consumers receive accurate information about drug side effects and other risks. Dr. Buckley gives the example of watching TV commercials several years ago, where drug risk information was spoken “at the speed of light.” Today, due to updated rulings from the FDA, drug risk information is spoken in a slower and clearer manner—all while images of smiling medication users continue to appear on the screen. This odd juxtaposition may help make consumers question the use of that particular medication more, she says.
The question is how to get these potential risks and side effects across via the Internet and social media, where both users’ attention spans and available space are often much smaller than in other venues. There is also the concern of whether messages spread via the Internet can be tampered with, Dr. Buckley says.
A concern specific to rheumatology is size of the drug market. “We are a small group of influential prescribers. Our drugs are often the most prescribed or the most expensive out there,” says Dr. Cush. “What happens if [the situation with Tasigna] were to occur with a biologic? Or a Celebrex?” In other words, it is particularly important that manufacturers and marketers of rheumatologic drugs pay close attention to the FDA’s reaction to the Tasigna website and any similar situations that emerge in the future.
Implications for Physicians
Although any forthcoming FDA guidance regarding Internet and social media advertising will have the most significant impact on pharmaceutical companies, there will likely be implications for physicians. “If doctors are part of the promotional process—for example, physicians serving as experts promoting a treatment in text, audio, or video—then their opinion can reach a younger and wider audience,” Dr. Buckley says.
Internet advertising now and in the future will also affect physicians because patients will ask questions about what they see online, as they do now with other DTC advertising, Dr. Cush says. “A person who has fibromyalgia may want to know about Humira. They may want to spend four or five minutes of their 15-minute visit discussing the drug because their cousin sent them a Facebook feed for it,” he says.
The guidance from the FDA could also have an ancillary effect on physicians as they start promoting their practice and experience via the Internet, Dr. Cush adds.
He believes the guidance from the FDA regarding Internet advertising will address what could specifically violate FDA regulations. Dr. Buckley believes the guidance will be very similar to that for print media, requiring pharmaceutical companies to have their online ads approved by the FDA before circulation, list risks as well as benefits, and not make unjustified claims about superiority.
Vanessa Caceres is a medical writer and editor in Florida.
