FDA has released draft guidelines on how drug companies and medical devices makers can use social media to discuss off-label uses of their products, Fierce Government IT reports.
The agency is accepting comment on the draft guidelines until March 26.
Details of the Guidelines
According to the draft guidelines, drug and medical device firms only can provide answers that are non-promotional and fair when asked questions through social media sites like Twitter and YouTube.
The answers also should be private, "provided only to the individual making the request directly to the firm," according to the draft guidance.
The guidelines state that the person responding to consumers' questions should not be a sales or marketing employee because those workers focus "on promoting a firm's products" (Bernhart Walker, Fierce Government IT, 1/4).
FDA spokesperson Karen Mahoney said the draft guidance represents "the first of multiple planned guidances that respond to testimony and comments" from a November 2009 public hearing on the pharmaceutical industry's use of social media (Thomaselli, Advertising Age, 12/30/11).
Reaction to Proposed Guidelines
The guidance focuses only on social media discussions of off-label uses for drugs and devices, leaving certain aspects of social media use unclear for pharmaceutical and medical device companies, according to Slate's "Future Tense" (Bosch, "Future Tense," Slate, 1/3).
A drug company digital director said the draft guidance "leaves a lot open to interpretation."
Jim Dayton -- senior director of emerging media for InTouch Solutions, a digital marketing firm -- said that "however ambiguous some might see this, I do not think this document should stop anybody form using social media."
Peter Pitts -- former FDA associate commissioner and current president of the Center for Medicine in the Public Interest -- said he doubts there will ever be clear rules governing social media marketing in part because of the evolving nature of social media sites (Advertising Age, 12/30/11).