If you've been waiting for another brain wave from the FDA about social media, look no further: The agency has issued new guidance for pharma's interactive marketing activities online. If you've been waiting for a unified theory of social media, however, this brain wave isn't it.
The new guidance does set up some ground rules that could be really helpful to pharma types wrangling Twitter and Facebook accounts; blogs and blog comments; disease-management and -awareness websites; and so on.
For instance, companies aren't required to submit tweets, status updates, Instagram shots and so on before they're actually tweeted, posted or sent. That's obviously a good thing; otherwise, social media would be virtually dead in the water in the drug business.
Companies do have to submit all of the above for FDA review, however, but only after the fact. Reporting activity via "real time" sites, e.g., Twitter, apparently can be done monthly. No screen shots of postings required, either; it looks as if a link to the feed in question would suffice. Those monthly reports may be a hassle, but it could be much worse, no?
But the FDA is casting a pretty wide net. Overall, the agency would require a company to submit site layout and content from "interactive media sites that are owned, controlled, created, influenced, or operated by, or on behalf, of the company," Nancy Parsons, an attorney with Hogan Lovells in Washington, DC, told FiercePharma. The rules apply "even if the company's influence is limited in scope" and can include promo activities on other people's websites, Parsons adds.
Significantly, the new guidance might help thaw back-and-forth communication between drugmakers and patients. In other words, drugmakers may be able to turn on their websites' "comments" feature without submitting all those comments for agency review. Previously, the FDA appeared to take a skeptical view of user comments--in fact, there was some indication that drugmakers would be on the hook for those comments, not just the company-generated material that prompted them.
Now, "FDA generally won't consider independent, user-generated content on a company-owned or company-controlled site to be promotional content of the company subject to reporting requirements," Parsons notes.
Lots of questions remain. For instance, how much "influence" is enough to put a drugmaker on reporting duty for a third-party site? But the guidance does address some of the industry's pressing questions, and in a way that should ease social-media fears. Drugmakers have till mid-April to file their critiques with the FDA.
"[B]y answering previously open questions, the guidance allows pharmaceutical and biotech companies to more freely engage in social media communications," Parsons figures. Plus, "the substance of the guidance shows FDA taking a practical approach that makes it possible to meet regulatory obligations while actively participating in 'real time' communications."
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