The Food and Drug Administration issued Dec. 27 draft guidance (.pdf) for pharmaceutical and medical device companies on the use of "emerging electronic media." FDA officials note that the guidance is not comprehensive; rather, it is the first of "multiple planned guidances" on the subject.
The draft guidance marks the first time the FDA has clearly addressed rules for pharma and medical device companies' digital communication--specifically mentioning channels such as Twitter and YouTube, reports AdAge.
If finalized, the rule would allow pharma and medical device companies to provide only fair, non-promotional information to questions posed over social media. The communication does not have to follow the strict requirements of direct-to-consumer advertising.
The draft regulation is strict about how the information is relayed and who does the communicating, however.
FDA wants public response to questions to be minimal--"email us here for more information" and direct messages over Twitter come to mind. "Information distributed in response to an unsolicited request should be provided only to the individual making the request directly to the firm as a private, one-on-one communication," explains the draft guidance. FDA notes that its concern in this area is that what is communicated publicly can stay online forever, and also that public responses could mention competing products.
The employee responding to unsolicited information requests over social media shouldn't be a sales or marketing person either, says the draft regulation, as those individuals are focused "on promoting a firm's products."
The draft guidance makes a clear distinction between "solicited" and "unsolicited" off-label questions, as the regulation only applies to unsolicited questions. Unsolicited questions "are those initiated by persons or entities that are completely independent of the relevant firm," and "requests that are prompted in any way by a manufacturer or its representatives are not unsolicited requests," says the document.
The guidance comes more than a year after the agency held hearings on the subject, according to sister-publication FiercePharma. The FDA also published a handful of warning letters in late December to pharmaceutical companies engaging in questionable promotion on their websites and social media channels, reports NutraIngredients-USA.
The draft guidance is out for comment until March 26.
- see the FDA draft guidance (.pdf)