FDA has long taken the position that firms can respond to unsolicited requests for information about FDA-regulated medical products by providing truthful, balanced, non-misleading, and non-promotional scientific or medical information that is responsive to the specific request, even if responding to the request requires a firm to provide information on unapproved or uncleared indications or conditions of use.
Furthermore, as these firms are regulated by FDA and have robust and current information about their products, FDA recognizes that it can be in the best interest of public health for a firm to respond to unsolicited requests for information about off-label uses of the firm’s products that are addressed to a public forum, as other participants in the forum who offer responses may not provide or have access to the most accurate and up-to-date information about the firm’s products.
[B]ecause product information posted on websites and other public electronic 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 to individuals who have not requested such information. In this circumstance, communications to persons who have not requested information may promote a product for a use or condition for which FDA has not approved or cleared. FDA is also concerned about the enduring nature of detailed public online responses to off-label questions because specific drug or device information may become outdated (e.g., new risk information may become available).
Therefore, any substantive communication about off-label uses for the product, in response to the original unsolicited off-label question, should occur solely between the firm and the individual who made the request. Regardless of the fact that the original, unsolicited off-label question may have been available to a very broad audience, the firm should not make its detailed response with off-label information publicly available within the same forum.
This is simply weird. The FDA admits that the information itself, properly vetted and hemmed in by mandatory disclosures and fair balance (not the Fox News kind, either) requirements is not misleading if done privately. How could it possibly be misleading when it’s public? Especially when the alternative is so easy. If the FDA is worried about the information somehow going stale, the posting companies could be made to keep track of where they post and update the information accordingly. That’s not hard. We do it all the time on our own scorecards.
The public/private distinction is just silly – the FDA is making a mockery of free speech yet again for its bureaucratic reasons. Equally silly is the FDA’s solicited/unsolicited distinction. The same information that the FDA admits is truthful and beneficial in one context becomes illegal in another, for reasons having nothing to do with the content of the speech and everything to do with the FDA’s seeming death wish to continue banning truthful off-label promotion. Well we have seen the future and it is Sorrell – we fervently hope.
And, if you run with this idea and it makes you rich, don’t forget your friends at the Drug and Device Law Blog (a modest finder’s fee would not be looked upon negatively!)