How pharma learned to stop worrying and love the tweet
Armed with FDA guidelines, industry reaches out to social media
On July 10, Bristol-Myers Squibb sent out a routine tweet to its followers. That may seem like an unremarkable act, but there was more thought behind the message than might be obvious.
The tweet read: “Third quarter submission to FDA planned for I-O agent for advanced melanoma,” and contained a link to a news release announcing the upcoming submission of Opdivo to the FDA. But it also avoided running afoul of regulatory guidelines, included the important link to a longer explanation and, above all, was current.
It looks easy -- but it wasn't. It also echoes the pharmaceutical industry's experience with social media. So far, it's been a rocky journey.
In the beginning...
More than four years has passed since FDA held a public hearing to discuss Internet-related and social media issues faced by drug and device manufacturers. The goal at the time was to help the agency create policies around various social media platforms and product websites.
The well-attended hearing showed how many interests were coming to the social media arena: In the audience were representatives for consumers, pharma executives, regulators, advertisers and marketers, IT specialists, caregivers, Internet vendors, healthcare professionals and patient groups.
After the meeting, there was the expectation that guidelines would be forthcoming -- not right away, but perhaps within the next year to 18 months. That did not happen, and many companies subsequently floundered trying to decide how to leverage social media's power without running afoul of regulatory guidelines.
There also was the challenge of managing third-party interactions. Putting up a Facebook page would invite anyone to write anything -- positive or negative -- that may not reflect a balanced approach to discussing a medical product or device. Nonetheless, everyone understood the opportunity costs of not having a social media presence.
Perhaps this widespread confusion is why, five years after that hearing in November 2009, 50% of large pharmaceutical companies still are not using social media. During those five years, there has been a revolution elsewhere in content marketing using various social media platforms -- but the pharma industry has been sitting on the sidelines, still waiting for direction.
Finally, draft guidance
That direction finally came June 17, when FDA published draft guidance on social media. The guidance was divided into two parts, with the first providing direction on how to present risk and benefits information using the Internet and social media.
“We understand that communicating on electronic Internet sites with character space limitations can be challenging," Thomas Abrams, director of the FDA Office of Prescription Drug Promotion, wrote in a recent FDA blog post. "But no matter the Internet source used, benefit claims in product promotions should be balanced with risk information. And companies should provide a way for consumers to gain direct access to a more complete discussion of risks associated with their products.”
The second guidance gives direction on how to correct third-party information related to a company’s own drugs or medical devices. “We recommend that any corrections should address all misinformation in a clearly defined portion of the forum on the Internet or social media, whether the information is positive or negative," Abrams wrote.
In the post, Abrams acknowledged that FDA’s consideration of social media sites and other Internet-related matters is evolving -- a statement that is true of the entire social media landscape. And he linked to a number of FDA guideline statements involving various aspects of social media.
"FDA sees social media as an important resource for industry and is committed to developing additional guidance for drug and device manufacturers that outline the agency’s current thinking," he wrote. "We do all of this work with the best interest of patients in mind."