A group called the “Social Media Working Group” (SMWG) comprised of representatives from Amgen, AstraZeneca, Bristol-Myers Squibb, Millennium Pharmaceuticals, and sanofi-aventis U.S., recently submitted written comments to Docket No. FDA-2009-N-0441 (see here) regarding Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools. You can find the SMWG’s comments here.
Two significant things to keep in mind about the SMWG and its comments are: (1) the companies that are missing from the group (such as Pfizer, UCB, GSK, Merck, Novo Nordisk, etc.), many of which have engaged in social media, and (2) the non-binding nature of the suggestions made by the group; ie, “each representative of the SMWG continues to remain free to have independent opinions on issues presented…”
You may recall that the FDA requested feedback from the drug industry and other interested parties on a number of specific questions, most of which relate to social media. At a November, 2009, public hearing, the FDA heard mostly from drug companies and their agencies (see “Industry Groups will Eat Consumer Advocates’ Lunch at FDA Social Media Public Hearing“)
In its comments to the FDA, the SMWG focuses on how to handle off-label comments (ie, comments about product information or use that is not consistent with the FDA approved full prescribing information), how to submit to promotional posts to FDA, and how to deal with adverse event reports on social media sites that are either owned by them or by independent 3rd parties.
Guidelines Needed
“If companies choose to monitor the site,” says the SMWG, “they should consider establishing guidelines for anticipating, monitoring, and responding to unsolicited off-label comments and questions posted by third-party visitors within company-hosted online communities.” These guidelines would be communicated to online community members via a Terms of Use agreement. “FDA could require that companies monitor such sites/communities on a regular basis (each business day, for example) to ensure compliance with the Terms of Use and take appropriate action when the Terms of Use are violated.”
For product-related sites, the SMWG recommends the following Term of Use:
This site is intended as a forum for discussing FDA-approved uses of [product x], which are [insert approved indications]. As such, postings containing product discussions that are not consistent with the FDA-approved prescribing information (include hypertext link to full prescribing information) are subject to removal. Product-related questions should be directed to Customer Service or [other appropriate department for handling] at [toll-free number, fax, email].
Censorship vs. Moderation
With regard to responding to unsolicited request for off-label information, the SMWG recommends that the site “retain the off-label request posting, along with the company acknowledgment, to ensure the community is informed of its off-label nature. This avoids the risk of an off-label question being viewed without clarification” and also avoids, as the SMWG says, “undue censorship.”
I have a problem with this. First of all, the cat’s out of the bag if you allow unsolicited off-label posts to be retained, even if for a short period of time. Given the viral nature of social media such as Twitter, the post can be replicated throughout the Internet within hours and reach the top of search engine results.
The SMWG is a bit vague on how long off-label posts should be retained and leaves it up to individual companies to decide: “The company would remove the off-label posting/statement within a reasonable time to ensure availability of this information is limited. Companies should also determine criteria for type of information to be addressed/corrected and length of time information would remain online.”
A better way to handle this on sites owned by pharmaceutical companies is through enlightened moderation. This is how I handle comments made to this blog. You may call it “censorship,” but reviewing comments before they are posted has become the norm for pharma companies that now have blogs (ie, Johnson and Johnson and GSK, neither of which are part of the SMWG).
IMHO, any Terms of Use policy of a company-owned social media site should include moderation of posts BEFORE they are published and denying publication of any post that mentions off-label usage. The Terms should also specify what is meant by “off-label” usage as I am sure not many consumers realize that their physicians may be prescribing a product for a use that has not been approved by the FDA.
Form FDA 2253 Submission
The SMWG recognizes that FDA’s requirement that drug companies submit all promotional materials at the time of initial dissemination is “particularly challenging for social media, which involve real-time dialogue among community members.” The group suggests that, for company-owned sites, the following items be submitted on Form 2253:
- Static elements (graphics, indication, important safety infonnation, package insert link, etc.)
- Proactive promotional company postings such as those intended to introduce a topic for discussion
- The site’s URL, which would constitute a submission of the online discussion by reference
“An alternative to the time of first use submission is to batch and submit discussion threads occurring within company-hosted discussions. These could be captured and submitted on a weekly or monthly basis.”
This alternative idea seems to include ALL posts made on the site, not just the “proactive promotional company postings.” If the site is a successful social media site, the number of postings can be large. It could become a burden for the FDA to review all this material! Of course, the industry may pay for this through new user fees, but that would require an act of Congress. Not likely in this do-nothing political era!
Note: For further discussion of this issue, including results from a recent Pharma Marketing News survey, see “How Should Pharma Companies Submit Social Media Content for FDA Approval?“
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