Drug company Novartis recently received a warning letter from the Food and Drug Administration’s Division of Drug Marketing, Advertising, and Communications about a widget enabling visitors to the Web site for the company’s drug Tasigna to share information with their Facebook friends
The FDA claimed that the widget for Tasigna, a leukemia drug, violated federal regulations because it made representations about the drug’s efficacy and failed to communicate any risk information. Tasigna’s Web site offered Novartis-created information about the drug that Facebook users could “share” with their friends by posting it on their wall or sending it as a separate message. For example, one item read, “In addition to taking Tasigna (nilotinib) 200-mg capsules, talking to your doctor and receiving health tips can help you treat your CML [chronic myeloid leukemia].” For promotional materials to be truthful and non-misleading, they must contain risk information in each part as necessary to qualify any claims made about the drug,” the FDA said.
Why it matters: Because drug advertising faces stricter regulation than other industries, companies have expressed concern about meeting their requirements in the world of social media. In April, pharmaceutical companies filed written statements with the FDA, urging it to adopt guidelines specific to Web marketing and the use of social media, arguing that it is impossible to convey the risk information required in other forms of advertising in a 140-character Tweet or an Internet banner ad. While the FDA has set no timetable for issuing such guidelines, its letter to Novartis – the first sent directly addressing marketing efforts on Facebook – highlights the fact that the agency is monitoring the use of social media.
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