Social Media and Pharmaceutical Companies – New Rules Issued by FDA

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 The draft guidance encourages all responses to unsolicited requests for information, which could include requests from physicians for information on off-label uses for certain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.

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.

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.

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.

Source: American Medical News