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Nearly 70 pharma execs, new media mavens, and even Joe Q. Public packed last week's FDA social media hearings to plead for some form of guidance on how to handle Tweets, blog comments, and off label discussions online.
After months of hemming and hawing, a flurry of warning letters, and public outcry for guidance, FDA chose to address the issue of social media head-on last week, with a two-day forum broaching topics from Twitter to Sidewiki.
At one point during the jam-packed hearing, a speaker compared the event to speed dating-and the analogy wasn’t far from the truth. Sixty-nine speakers crammed 77 presentations into 10 to 15 minute pitches-and almost every one called for some form of regulatory action.
“This is the Super Bowl of Part 15 hearings,” Peter Pitts, president of the Center for Medicine in the Public Interest, said to the FDA panel. “Social media is a social movement. Healthcare companies must engage in social media. If a consumer with no financial ties to drug companies puts a comment on a health site, should it be considered regulated speech? In this case letters to the editor should be regulated.”
“The Internet is the go-to media for more than half of Americans looking for information, but also a breeding ground for bad information,” said the Coalition for Healthcare Communication’s John Kamp, early last Thursday. “FDA policy can make it possible for consumers to find reliable information on the Internet. We suggest FDA look at ways to scrutinize widespread health inaccuracies on the Web.”
Kamp suggested that FDA create a list of “can dos” for advertising on the Web, similar to guidelines from the Federal Trade Commission.
PhRMA’s Jeffrey Francer called for FDA to approve use of a logo with a standard warning like: All drugs have risks, click for more information. The tool could be used on microblog posts like Twitter. However, FDA noted that this poses a problem, because companies aren’t required to prescreen advertisements. One panelist said that she wasn’t sure how the FDA logo would be included if ads aren’t actually approved.
A Click Away
A large contingent of presenters spoke in support of a one-click rule, or the ability to post risk information within one click of a short-form text advertisement. Pharma came under fire in April after FDA sent warning letters to companies that were running branded search ads with disease information, but no risk information.
“People don’t care what marketers or the FDA has to say. They care about themselves, and when they look for information online they are hyper-focused,” said Fard Johnmar, founder of Envision Solutions. “People look for information based on what is on the page and what the link is associated with. If the information is weak or misleading, they will look somewhere else.”
Google’s Health Director Mary Ann Belliveau told FDA that ads with both brand and benefit information are more informative to a user query, and that users are more likely to click on an ad if it contains a URL that they recognize. Google recommended a standard format across the Web for sponsored links. Customers must click the full listing with short description of risk, two direct links, brand info, and health info. No word yet on how these ads will sit with FDA, but you can read more about the ads here.
“Risk-value proposition is more valuable to consumers than risk,” said James Sandino of Integrated Media. “What’s missing is a sense of clarity, ownership, and a sense of responsibility for what has been put forth. If you build a site, they will come, and then comment. And if you write ‘go here for more information,’ they will.”
Commenting on Comments
Another sticking point at the hearing was the matter of how pharma should handle conversations about off-label use and adverse reactions to drugs mentioned in third party forums or blogs.
“Does an anonymous comment on a site warrant an investigation?” asked AdvaMed Advertising and Promotion Working Group Co-Chair Tony Blank. Christopher Schroeder, CEO of HealthCentral, agreed that advertising on a page with user-generated comments shouldn’t be penalized.
“The mass of adverse events reported on social media sites doesn’t meet FDA requirements,” John Mack, editor of Pharma Marketing News said on Friday. “Few companies have standard operating procedures for processing adverse events from social media sites.”
Mack suggested that pharma companies should monitor third party sites and make a concerted effort to correct information. It should only be mandatory for them to correct their own sites. He also suggested making drug companies use “hashtags” to help FDA find drug topics on sites such as Twitter.
Michele Sharp, Lilly’s senior director, US regulatory affairs, said that there are several unanswered issues around Internet promotion, and explained how Lilly launched a blog on Medscape to share information with physicians. “We are prescreening all comments, and not mentioning products because they don’t know what the fair balance rules would be,” Sharp said. “We are concerned that if we offer product information it could lead to off-label discussions.”
“Exchange of information on the Internet can last for years,” said Allan Coukell, director, Pew Prescription Project. “Why should manufacturers be responsible for information transmitted through a third party about their drugs? Companies are not responsible for information created by third parties and hosted on third party sites, such as Wikipedia.”