FDA Drafts Pharma Social Media Advice

The agency releases draft guidelines on unsolicited questions about off-label use, but leaves many questions about social media marketing unanswered.

By | January 3, 2012

The US Food and Drug Administration has finally weighed in on pharmaceutical company's use of social media to respond to unsolicited questions about off-label use of approved devices and drugs. The guidelines, however, fall far short of a comprehensive rulebook for social media marketing that many were hoping for.

The new guidelines help pharma companies respond when a consumer reaches out via Facebook or Twitter to ask questions about off-label use of a drug or device. For instance, a company could respond to questions about the safety of drug for a certain type of person, but if a user asked whether Lipitor could make them smarter, for example, the company should direct the consumer to the drug safety and use webpage. The guidelines are completely voluntary, but the FDA does warn that actively promoting off-label uses could be used as evidence that the company is pushing a “new intended use” that has not been okayed by the FDA, which would violate the law.

Television and print marketing is tightly regulated by the agency, but social media marketing, which has exploded in recent years, is currently unregulated. Big pharma spent nearly $1 billion in online marketing in 2011, according to Ad Age.


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