Pressure from consumer groups and drug companies alike has forced the FDA to consider issuing guidance on how so-called Web 2.0 applications can be used in advertising drugs and medical devices. Pharmaceutical and device manufacturers have increasingly been using YouTube, Twitter, blogs, podcasts, Wikis, and other social media tools to take advantage of the emergence of the Internet as a vehicle for advertising. But the use of these tools, as well as their concomitant space limitations, sometimes makes it difficult for companies to comply with the FDA’s advertising regulations, which were written for print media and television.
Michele Sharp, PharmD, Senior Director of U.S. regulatory affairs at Lilly, told a two-day FDA meeting in November:
“Frankly, to date, Lilly has avoided significant interaction with health care professionals and patients about our products in social media forums—largely because of a lack of clarity in understanding [the] FDA’s expectations as to how we could participate and comply with FDA requirements.”
In March 2009, in its first indication of concern, the FDA sent out warning letters to a number of drug companies requesting that they revamp their current online advertising campaigns. Letters to Merck & Co., Eli Lilly & Co., Genentech, Inc., and others cited the “sponsored links” for their products. These links pop up when someone types a health term into a search engine such as Google. The FDA complained that those banners were devoid of information on the topic of risk. The agency also criticized Glaxo-SmithKline for its visual ads on behalf of Treximet (sumatriptan/naproxen), an agent for migraine. The agency said that the company had communicated the drug’s serious risks in smaller text, and they were less prominently displayed, than the eye-popping visual images appearing on the computer monitor meant to highlight the drug’s effectiveness.
A citizen’s petition submitted to the FDA four months earlier, in December 2008, might have led to those March letters. That petition was filed by the Prescription Project, a coalition of groups led by Community Catalyst in partnership with the Institute on Medicine as a Profession. The organization is funded by the Pew Charitable Trusts. The petition asked the FDA to enforce its rules and to require Abbott Laboratories, Stryker Corporation, and Medtronic, Inc., to withdraw their video ads for medical devices used in heart, hip, and neck surgeries from YouTube.com. In addition to objecting to those ads, the petition requested that the FDA issue guidelines for consumer-directed broadcast advertising of prescription drugs and restricted devices on the Internet to clarify how federal and FDA rules apply to online drug and device promotions.
The September 2009 Federal Register announcement of the November 2008 meeting raised many of the issues that the Prescription Project had raised in its petition. Some of the questions discussed at that meeting included the following:
When a company sets up a chat room for online discussions of health conditions, should the company be held responsible for information provided by participants in those sessions?
How should data on safety and risks be displayed in the sponsored links (the subject of the FDA’s warning letters in March 2009)?
Should there be a “one-click rule” so that complete information on the risks of a drug or a device would be only one mouse click away?
What is a company’s responsibility to communicate adverse events that might be associated with its products reported on the Internet?
The fact that the FDA is asking these questions, but has no answers, helps to explain why pharmaceutical companies have been slow to jump into Web advertising. Most firms seem to be unsure of how FDA rules apply and are hesitant to expand their Internet advertising presence—whether it is aimed at physicians, pharmacists, or consumers—when those moves could result in enforcement action by the FDA. Most drug companies are waiting for clarification from the FDA before committing to aggressive Web strategies.
“The warning letters sent earlier this year around paid search ads have only heightened this uncertainty,” explained Lilly’s Dr. Sharp.
But Lilly has dipped its toe in the water. It launched a blog on Medscape, written by its medical team in the U.S., to share information with physicians. The blog allows the usual give-and-take wherein comments can be posted. However, Lilly is pre-screening all comments and is declining to post any remarks that mention a product for fear of running afoul of the FDA’s “fair balance” requirement.
Pfizer has done something similar. It collaborates with Sermo, a physician-only social network with 111,000 doctors, about 20% of the nation’s physicians. Pfizer, in essence, is monitoring the conversations. When a topic comes up that is relevant to its products, the company can jump in, Web-wise. Pfizer initially made a relevant Webcast available to discussion participants; however, physicians rejected that “canned” approach. Eventually, Pfizer and Sermo developed a tool, called AskRx, which allows a doctor to submit a medical inquiry instantaneously to Pfizer’s medical information department. Pfizer promises to respond to that doctor in less than 24 hours with a scientific answer that is customized and concise. Pfizer is looking to expand this service offering to physicians’ “smart” phones.