It's June. Three weeks to go until July 9, the FDA's self-imposed deadline for wrapping up its social media guidance. And now, pharma marketers are in luck: The agency has unveiled two more pieces of the puzzle.
They're two important pieces, too. One addresses the risks-and-benefits disclosures always required in pharma promotions. The other deals with damage control: how drugmakers can correct third-party misinformation.
This spells good news. Finally, drugmakers will have some clarity on the FDA's till-now-murky approach to real-time marketing. Maybe that will get some cautious companies off the sidelines and into social media. And maybe it will persuade the less-cautious to move beyond disease awareness and into actual product promotion.
"The draft guidances create a pathway for companies to expand their use of interactive media to promote their products," Nancy Parsons, counsel with Hogan Lovells, told FiercePharmaMarketing. "Regulatory uncertainty had caused many, but certainly not all, companies to sideline initiatives to use social media to promote drug products, and instead focus their interactive media efforts on building communities around diseases and health conditions."
For the FDA, it was a balance between allowing communication and serving potential patients with "clear, accurate, truthful and non-misleading information," irrespective of the internet source, CDER's Thomas Abrams wrote on the agency website as the draft guidances were released. Companies have 90 days to file comments with the FDA on the draft guidances.
It's still unclear how the FDA will treat pharma's activities on interactive media sites, and "particularly where a company has some limited influence over the content of a third party site," Parsons said. But the proposed rules are a step forward, she added.
The risks-and-benefits guidance lays out the FDA's stance on how that information should appear on social media. That includes tweets and sponsored links, character-space-limited communications that have landed drugmakers in hot water in the past. The FDA makes immediately clear that if a company presents the benefits of a product, it also has to lay out the risks, regardless of space or character limitations.
The second guidance offers insight on when and how the FDA expects companies to respond to mistakes made by third parties. The document outlines whether the draft guidance applies to a company and defines what, exactly, companies are responsible for fixing.
"The two different guidance drafts reaffirm the FDA's intent that information about potential risks be included along with the potential benefits, but also recognizes the realities of today's social media platforms," Lori Leskin, a partner at law firm Kaye Scholer, told FiercePharmaMarketing. "Up until now, pharmaceutical companies have not engaged with the public on social media, in part due to the uncertainty of the regulatory atmosphere governing their participation."
In an Eye for Pharma survey conducted this month, 65% of respondents agreed that better use of social media is "genuinely" important to pharma's future. And the industry has a ways to go, according to a recent report from the IMS Institute for Healthcare Informatics.
The IMS Health report found that almost half of pharma's top 50 manufacturers were active in social media--at least to some extent. But overall, a lack of regulation stymied the companies and a lack of "relevant, accurate content" stymied consumers. The IMS Health researchers, who developed a social media engagement index, found that "social media engagement lags significantly within the population segment that uses healthcare the most."
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