A customer loads Pfizer's Facebook page and leaves a comment on a wall post asking about an off-label use of one the company's products. How should the pharmaceutical company respond, if at all?

That issue is one of the many topics to be addressed in guidance the Food and Drug Administration is required to issue within two years.

Section 1121 of the Food and Drug Administration Safety and Innovation Act (S. 3187), signed into law by President Obama on July 9, tasks the agency with issuing guidance on its policy "regarding the promotion, using the Internet (including social media), of medical products that are regulated by such Administration."

Areta L. Kupchyk, a partner with Nixon Peabody LLP in Washington, told BNA that the forthcoming guidance "is essential." The developing social media and internet media are "different from broadcast and print. They reach a global audience, can exist indefinitely, . . . [and are] an active dialogue between people."

Kupchyk said she believed the most contentious issue will be how companies should respond to off-label questions posed on social media platforms. "Almost everyone" objected to the FDA's stance in a December 2011 draft guidance that companies respond privately to any question on social media that addressed off-label uses, she added.

The FDA had noted that it may be true "that the original, unsolicited off-label question may have been available to a very broad audience." Nonetheless, "the firm should not make its detailed response with off-label information publicly available within the same forum."

The issue is important because federal law only permits companies from promoting a drug or medical device for uses that have received FDA clearance. The FDA also has not been hesitant to issue warning letters to companies it believes have engaged in improper off-label communications through social media.

Copyright 2012, The Bureau of National Affairs, Inc.