FDA issues first social media rules for drug companies

Proposed regulations address online interaction with consumers, but pharmaceutical manufacturers say they need more specific guidance.

By — Posted Jan. 25, 2012

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The Food and Drug Administration is giving pharmaceutical companies some rules for how they interact with consumers on social media. But the companies say they need a lot more clarification from the FDA before they're comfortable getting back online again.

The draft guidance encourages all responses to unsolicited requests for information, which could include requests from physicians for information on off-label uses for certain drugs, to be made in a nonpublic format.

The agency calls on companies to respond to public requests, such as those sent through Facebook or Twitter, by guiding the requestor to the appropriate personnel or department for private, one-on-one help. The agency said the private responses should be science-based and answer only the question or questions asked.

The guidance does not apply to information or requests received in response to a solicitation by the pharmaceutical or medical device company.

The release of the guidance was met with lackluster support from industry watchers who are still waiting for comprehensive guidance that will encompass the many areas of social media with which pharmaceutical companies are struggling.

Kate Conners, spokeswoman for Pharmaceutical Research & Manufacturers of America, said the organization planned to submit comments on the proposed rules. "We continue to wait eagerly for adequate FDA guidance on this issue."

Specifically, pharmaceutical companies want to know if they are liable for information posted by third parties on social media sites owned and operated by the pharmaceutical companies. What to do with information that could be considered reporting an adverse drug event is especially troublesome to the companies.

In August 2011, many pharmaceutical companies shut down Facebook pages -- especially those devoted to particular drugs -- after Facebook stopped giving them the option to shut off public comments on those pages. The companies cited a lack of FDA guidance on how to handle social media comments as their reason for shutting down the pages. Most vowed to keep their pages shut down until the FDA provided guidance on how comments be handled.

The FDA's rules do not affect social media sites maintained by physicians or health care organizations. Many physician organizations, including the American Medical Association, have issued guidance to their members to proceed with caution and abide by patient privacy laws when communicating with patients online.

The FDA is accepting public comments on the guidance through March 26.

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