More evidence that social media is a potential minefield for drugmakers, at least until FDA finally makes up new rules. The agency's DDMAC division has cited Novartis for a Facebook widget on its website for the leukemia drug Tasigna. The problem with Novartis' widget wasn't of a sort exclusive to online media, however.
Facebook Share widgets let web surfers generate links to sites they like and share those links with their Facebook friends. In generating the links, the widget adds a short description of the site, and it's that description that got Novartis into trouble. It offers efficacy claims, the DDMAC letter says, but "fails to communicate any risk information." Plus, DDMAC says, the widget doesn't adequately specify Tasigna's indication, and it "implies superiority over other products."
Of course, the same infractions show up in DDMAC letters about brochures, print ads, and other sorts of media. But the difference is that a Facebook widget doesn't generate much text at all. How is a drugmaker supposed to fit all the required info in one short paragraph?
This reminds us of the Google trouble last year, when 13 drugmakers were hand-slapped for leaving risk info out of their tiny little Google links. We're truly interested in how the FDA plans to deal with the brevity online marketing requires. But for that we'll have to wait until the agency promulgates its rules.
- get the FDA's letter
- here's the promotional material
- read the MM&M story
ALSO: The agency also said in letters posted on its website this week that Novartis used a misleading brochure for its blood-pressure drug Exforge, and that AstraZeneca PLC used misleading promotional material for the antipsychotic Seroquel. Exforge brochure | Seroquel promotional material | Report