For years, members of the pharmaceutical industry have awaited the release of what has been dubbed by many as "The Social Media Guidance," a document intended to explain in full detail how companies could use social media platforms to advertise and promote their products while meeting the US Food and Drug Administration's (FDA) strict regulatory requirements.
There's just one problem, according to FDA officials: There is no single social media guidance in development.
There are several.
The issuance of guidance on social media is required by the Food and Drug Administration Safety and Innovation Act (FDASIA), Section 1121 of which calls for FDA to, by August 2014, "issue guidance that describes FDA policy regarding the promotion, using the Internet (including social media), of medical products that are regulated by [the FDA]."
For members of industry, the allure is relatively straightforward. As social media networks like Facebook, Twitter and Instagram have proliferated and become popular, opportunities exist to reach out to those users and members of specific communities to market a drug or answer questions.
However, the varied capabilities of the platforms represent myriad problems. For example, it is difficult to contain all the information about a product in a single 140-character Tweet. FDA has sanctioned a company in the past for "liking" an unapproved claim on its Facebook wall. And even hidden metadata can be grounds for FDA finding a claim to be misbranded.
With so many questions left unanswered on how to appropriately use the platforms, industry has clamored for guidance from the agency-guidance that now appears to be forthcoming.
Social Media Guidance: One Emerges
But a curious thing happened on 13 January 2014 in the form of a guidance that seemed to take aim at some of the issues industry had been raising about social media. Namely, since advertising and promotional materials have to be provided to FDA at the time of initial dissemination, would each tweet or Facebook post have to be filed with the agency as well? (Answer: No)
The guidance, however, clearly wasn't all-encompassing, and neither was it The Social Media Guidance that had long been sought by industry.
So what was it?
Part of a series of social media guidance documents, an FDA spokesman tells Regulatory Focus.
While the agency maintains that the guidance released on 13 January 2014 actually meets the statutory requirements of FDASIA, FDA "plans to issue additional guidances for drug and device manufacturers related to the Internet and social media," Stephen King, an FDA spokesman, said in an email.
Those guidances, according to the same spokesman: "Issues with character space limitations, links (the
appropriate use of links), and sponsor correction of misinformation about their
products disseminated by third parties."
What Does this all Mean?
That could be both good and bad news for industry.
On the positive front, marketing and label review staff will benefit from shorter, more targeted and more nuanced guidance documents that will speak to specific concerns, such as the 13 January guidance document.
But less fortunately, industry could wind up waiting longer than it originally hoped for a full set of answers. By claiming that its new guidance satisfies the terms of Section 1121 of FDASIA, FDA has in effect written itself a blank check for time it can use to finish the rest of the social media guidance documents at its own pace.
All the same, King told John Mack of the website Pharma Marketing Blog that all outstanding parts of the social media guidance "will all come together before the July deadline."
"This is just the first little piece," King added, saying that the carved-up guidance documents are being released as they are finished in order to be "as responsive as possible."
"While this is a significant guidance for promotion
using social media, FDA remains highly committed to providing guidance and
clarification on the remaining topics in terms of both FDA time and human resources," King wrote.
Whether or not we see all of them by July 2014, though, remains to be seen.