Big Pharma sees danger, not safety, in FDA's new social media guidance

The FDA may have released its latest social media guidance in January, but judging by the industry's reaction, it appears some of pharma's marketers don't have any more answers than they did before. In fact, they have more questions.

With the comment period for the draft closing last week, Regulatory Focus rounded up comments from industry trade groups and drugmakers. They pointed to gray areas in the guidance and concepts they deemed too loosely defined. And with patients increasingly turning to social media for information and engagement, companies can't afford confusion.

PhRMA, for one, took issue with an assumption that companies maintain full control over third-party entities publishing on third-party websites--a premise the trade group called "overboard" and "inconsistent with the Federal Food, Drug and Cosmetic Act." It also charged the guidance with assuming all drugmaker statements about their meds on social media constituted promotional labeling or advertising.

"This expansive interpretation of labeling and advertising adopted in the draft guidance could chill truthful and non-misleading communication protected by the First Amendment," the trade group contended (as quoted by Regulatory Focus).

Pfizer ($PFE), too, expressed concerns with the FDA's level of authority over its speech, saying the guidance suggested the FDA had the power to regulate "all product communication" on social media--"jurisdictional creep," in its opinion.

Treato CEO Ido Hadari

And over-regulation could have far-reaching affects. In addition to limiting what companies can accomplish by way of online marketing, it could also hamper their ability to use social media as a tool in their larger marketing strategies, said Ido Hadari, CEO of social analytics provider Treato.

"The allowance of patient-generated content on pharma social assets and the ability to 'converse' with patients is powerful and important," Hadari told FiercePharmaMarketing in an email, adding that this sort of interaction could "fundamentally change the dialogue" between pharma marketing teams and consumers.

But that's if--and only if--the social media landscape is easy to navigate. No land mines allowed. "Only when marketers will feel comfortable and safe to talk to their audience in the social sphere can strategies change," Hadari said.

For marketing teams to reach patients and learn about their needs, the FDA needs to encourage freedom on social media instead of limiting it, Hadari said. Indeed, the FDA might want to make social media engagement mandatory.

"The future of pharmacovigilance, in my view, lies at the heart of actively participating in social media," he said. "Ambitious? Probably. The future? Absolutely."

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