Richman said that a flood of AERs is unlikely. “It’s not like people are waiting in the wings to submit adverse event reports,” he said, adding that he’s been told by companies of only a few previous instances in which potential AERs were seen in social media. “I don’t think we’re going to see a change in consumer behavior overnight.”
Companies also have ways of circumventing at least some of the problems of an open Wall. Page owners will be able to delete comments once they appear — like any other Facebook user — though that could mean 24-hour monitoring, by the company itself or a third party.
Pfizer, for example, will keep its pages online and “monitor to make sure no inappropriate comments are posted, and manage them if and when they occur,” said Andrew Widger, a company spokesman. Pfizer owns a hemophilia page with more than 2,400 likes and a multiple sclerosis page with more than 1,300. The company makes the hemophilia drugs Xyntha and BeneFIX and the MS drug Rebif.
Keeping pages open
Amgen will maintain its “Breakaway From Cancer” page, said spokeswoman Mary Klem, and the company is in discussions with Facebook about the change. Amgen sells the cancer drugs Neulasta, Neupogen and Vectibix. Novo Nordisk, which runs a hemophilia page and sells the NovoSeven RT treatment, is “unclear as to how the new Facebook policy will affect our current process” for comments, spokesman Ken Inchausti said in an e-mail. Both companies plan to monitor the situation.
Sanofi also has no plans to remove its pages from Facebook, said spokesman Jack Cox. The company runs a diabetes page with more than 1,500 likes and makes the insulin products Apidra and Lantus. According to Dennis Urbaniak, Sanofi’s U.S. vice president for diabetes, Facebook has become more than a marketing and branding tool.
“We’ve been able to get feedback that’s more genuine and relevant,” Urbaniak said. “We see [the page] as a way of getting to know patients better.” To avoid problems, the company avoids discussion of specific products and sets up “clear terms and conditions with the user” on its page, which also features safety information for its diabetes products.
Gary Kibel, a lawyer specializing in social media for regulated industries, said many of the potential problems with Facebook are “unique to pharmaceuticals.” The financial services industry comes closest but faces a less difficult situation. Facebook users might post Wall comments with insider information or promote certain stocks, but handling of those problems was largely addressed by the Financial Industry Regulatory Authority (FINRA), which released guidelines in 2010.
FDA guidelines
The FDA has not yet released guidelines for online engagement. A draft was expected by the end of last year, but was then delayed. The agency has said that it will not be providing platform-specific guidance, such as guidelines for Facebook Walls. Instead, it will provide higher-level principles for online communication.
“Policy and guidance development for promotion of FDA-regulated medical products using the Internet and social media tools are among our highest priorities,” FDA spokeswoman Shelly Burgess wrote in an e-mail. “Despite our limited resources and increasing workload, we remain committed to this area in terms of both time and human resources.”
Burgess was unable to provide a timeframe for the draft guidance, and that uncertainty has left the pharmaceutical industry concerned, said Jeff Francer, assistant general counsel for the lobbying group Pharmaceutical Research and Manufacturers of America (PhRMA).
“Companies always want to follow the law, but it’s up to regulators to ensure the laws are clear,” Francer said, noting how the urgent need for guidance has been highlighted by Facebook’s policy change.
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