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Navigating social media is challenging for pharmaceutical manufacturers given the current lack of direction from the Food and Drug Administration, experts said Oct. 2 during a Food and Drug Law Institute conference.
While FDA has released one guidance dealing with social media, there is a “relative vacuum of social media regulations,” Bradley Merrill Thompson, an attorney with Epstein Becker & Green PC in Washington, said. In January, FDA released guidance for industry on how to use prescription drug names in promotional labeling and advertising. The recommendations in the guidance pertain to product names in various types of media, including electronic and computer-based promotional labeling and advertisements, such as social media.
The best information comes from FDA enforcement actions, such as warning letters, Thompson said. There were around nine FDA warning letters in 2012 that mentioned Facebook, he said.
Thompson said there are five basic issues for pharmaceutical companies using social media, including:
• What online communications are pharmaceutical manufacturers accountable for?
• How can manufacturers fulfill regulatory requirements in social media?
• What parameters should apply to posting corrective messages on websites controlled by third parties?
• When is the use of links appropriate?
• What are the implications of monitoring and reporting adverse event information about products?
Conversations about drug products are already happening on social media sites, regardless of whether a company is aware of them, Dale A. Cooke, vice president/group director, regulatory review, Digitas Health, said. “You want to be aware of the types of discussions that are going on and engage some sort of social media monitoring service,” he said. Digitas Health is a Philadelphia-based advertising agency.
Cooke said companies should identify the people who are having the discussions about drug products on social media and figure out what, if any, actions to take.
“It is not appropriate to simply bury your head,” Cooke said. “The risk is not being aware of a potential public health risk” if people are distributing incorrect information about drug products.
“There is no real answer about when you have a duty to intervene,” Mark S. Senak, senior vice president of the public relations firm Fleishman-Hillard Inc., said. If misinformation “doesn't affect U.S. patients, you don't have to do anything.”
If, however, the misinformation does affect U.S. patients, companies may choose to do something about it directly by talking to the people who are distributing the misinformation, or indirectly by issuing a press release with corrective information, Senak said.
“As part of social media monitoring, you have to factor in [that] you will come across some” adverse event reports (AERs), Senak said. Manufacturers “need to build processes in to deal with AERs.”
Cooke said if a manufacturer sees a request for off-label information (about a use not approved by FDA) on a social media site and the request does not come directly to the manufacturer, then the manufacturer is not required to respond and “it could be best to leave it alone.” If a manufacturer wants to respond to the request, the manufacturer could provide a phone number on the particular social media site for requesting more information, Cooke said.
Cooke said companies should establish clear terms of conditions and use on Facebook pages and have the terms displayed prominently in the design. Specifically, he said companies should remind people visiting the page that it is a company page and not meant for product discussion.
If someone posts off-label information on a company's Facebook page, the company should delete it and post a corrective message, Senak said. “It's not sufficient just to take down the Facebook posting,” he said.
Brian J. Winterfeldt, a partner in the Washington office of Steptoe & Johnson LLP, also suggested that companies monitor Wikipedia.
“Wikipedia is not always accurate and could be harmful to consumers,” Winterfeldt said.
“It is important to put social media policies in place and update policies regularly” based on any new guidance, Winterfeldt said.
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