FDA guidelines offer little clarity on social media

February 06. 2012 3:00AM

FDA guidelines offer little clarity on social media

Still uncertainty for drugmakers, who remain cautious of interaction

After years of waiting, the Food and Drug Administration released its first word on social media in late December.

The draft guidance did little to clarify the FDA’s approach to social media, but it did serve to acknowledge that Twitter, Facebook and other services have become an important part of how drug companies communicate with the public.

Marc Monseau, a former Johnson & Johnson communications executive and founder of the consulting firm MDM Communications, in Princeton, said the social media sphere is still a work in progress for most drug companies “because, obviously, there’s uncertainty about what they can say about their products in that environment.”

Monseau said drugmakers also are lagging other industries because, with some exceptions, many haven’t set up the mechanisms necessary to track what people are saying about their products in real time.

The FDA’s December guidance dealt specifically with how drug and medical device companies should respond to unsolicited inquiries about unapproved uses for their products. The government doesn’t allow biopharmaceutical companies to market drugs for unapproved — or “off-label” — uses, though doctors may prescribe drugs off-label at their discretion.

The guidelines call for drug companies to respond only to requests specifically mentioning the company’s own products. In those cases, the only public response allowed is providing the drug company’s contact information. If the consumer then contacts the drug company, the FDA said it’s OK to provide information about the off-label use, provided it’s done so in a non-public manner, and that the information is limited to scientific — not marketing — information.

The guidelines are the subject of a public comment period that runs through March.

In the meantime, more and more companies are feeling their way through the social media realm.

“I think it’s gone from being an interesting experimental area to being a critical part of the business and communication plans that we’re developing, and something that has to be on the radar screen in everything we do,” said Bill Price, vice president of media relations at New Brunswick-based Johnson & Johnson, which uses Facebook, Twitter and YouTube, and operates two corporate blogs.

Price said J&J has internal and external policies, developed over time, to prevent regulatory headaches. He said he couldn’t comment on the FDA’s 12-page draft guidance, as the company is still reviewing it.

Devon Eyer, a director in Johnson & Johnson’s communications and social media teams, said J&J has learned along the way that social media are good communications tools, but not always the best ones.

“Some of the evolution is a recognition that it’s not always appropriate or it doesn’t always work to have some conversations in all spaces,” she said.

Sanofi, which has its U.S. headquarters in Bridgewater, uses Facebook and Twitter, and has a diabetes focused-blog.

Senior director Joan Mikardos, who heads Sanofi’s digital “center of excellence,” said the company strives to foster two-way communication on its social media outlets.

“If it’s just pushing information out about the company, then it’s really not social media,” she said. “So we try really hard to engage.”

Mikardos said Twitter generally fosters more two-way communication. The company is also using its diabetes site to gather input from patients and the public for Sanofi’s forthcoming innovation competition, in which inventors can earn a cash prize to develop diabetes innovations.

Sanofi has set up terms of use for its social media sites in order to prevent conversations that might cause regulatory problems. Off-label questions, for instance, are prohibited, as are product-specific comments — even if they’re about Sanofi’s own products.

“If somebody went on our Facebook page and they said Lantus is great, we would have to remove that comment, because it mentions our product,” Mikardos said.

Sanofi also declined to comment about the FDA’s draft guidelines because they have yet to formally comment to the agency.

In published reports, the FDA said it plans to issue further guidance related to social media in the coming months. In the meantime, Monseau said the lack of regulatory clarity will probably hold some companies back, though he doesn’t think that’s the right thing to do.

“I don’t think that should be put forth as an excuse for not engaging,” he said. “There are ways to do so. The issue is they require assuming some of the risk.”

The bigger issue, Monseau said, is that robust engagement in social media means breaking down internal silos, since social media require a customer service component, a public relations component and also a marketing component.

“They require some structural changes,” he said. “Those, I think, in many ways are almost more difficult.”

E-mail to: jkaltwasser@njbiz.com
On Twitter: @JaredKaltwasser