FDA issues online guidance
pharmafile | January 16, 2014 | News story | Manufacturing and Production, Medical Communications, Sales and Marketing | FDA, Twitter, digital, online, ugc
The FDA has issued new guidance on what online promotional material pharma needs to show it.
The document is out to consultation, with the industry able to put comments on it until April, and includes advice on how Twitter and Facebook accounts should be managed in relation to the FDA.
For example, it says companies do not need to submit individual tweets to the regulator before they are sent – an update on such real-time online activity can instead be included in a monthly report, with a link to the site considered sufficient.
This seems clear enough but there is likely to be a more detailed debate over the subject of user-generated content (UGC). While the FDA insists that a firm ‘generally is not responsible’ for UGC that is truly independent, it would be a surprise if respondents to the consultation did not seek further concrete guidance on exactly what ‘generally’ means in this context.
“At present FDA will not ordinarily view UGC on firm-owned or firm-controlled venues such as blogs, message boards, and chat rooms as promotional content on behalf of the firm as long as the user has no affiliation with the firm and the firm had no influence on the UGC,” the consultation currently suggests.
Pharma’s responsibility for submitting ‘interactive promotional media’ to FDA as required by post-marketing submission requirements is covered in some depth and the regulator has tried to shed more light on its thinking by giving examples.
These media may include pharma-sponsored microblogs, such as Twitter, social networking sites like Facebook, company blogs “and other sites that are under the control or influence of the firm”.
In essence, if pharma has any influence over the material, the FDA needs to see it: posts by a blogger paid by the firm would also fall into this category, as would a sales rep posting comments about ‘the innovative release mechanism of the firm’s product’ – even on an independent third-party site.
If a pharma firm adds an online forum to a product website on which users can post comments, then it must submit these pages and should it make “suggestions on the placement of its promotional messages on an independent third-party site” it must submit to FDA the promotion and the surrounding pages to ‘adequately provide context’.
Adam Hill
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