With hours to go in 2011, the FDA issued a sneaky draft guidance that many view as the first installment on its long-promised and oft-delayed advice on the use of Internet communications and social media for prescription drug promotion.
The document's title “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices,” doesn't sound promising for the digerati but it addresses several topics relevant to emerging media.
Among them: What electronic activities might result in a request for off-label being judged a “solicited” request; How companies may and may not respond to non-public unsolicited requests; How they should respond to unsolicited public requests; What sort of records companies should maintain of the interaction.
“Because product information posted on websites and other public information forums is likely to be available to a broad audience and for an indefinite period of time, FDA is concerned that firms may post detailed public online responses to questions about off-label uses of their products in such a way that they are communicating unapproved or uncleared use information about FDA-regulated medical products,” said the guidance.
A public comment period runs through March 29. For more on what it means see the Regulatory Update in MM&M's Interactive Guide, bundled with your February issue.