Novartis Shoulda Known the FDA Would Ban Its Facebook Widget

Managers at Novartis (NVS) will likely be fuming this morning because the FDA has demanded that the company stop using a Facebook widget that promotes its leukemia drug Tasigna. At first glance, that ire seems justified: the FDA doesn't have any rules for social media, yet it continues to randomly ding companies that try to use it.

The FDA started a long-promised regulatory review to write some rules for web 2.0 back in September but so far the agency has failed to produce anything that pharmaceutical companies can use as guidance. It seems fundamentally unfair for the government to discipline companies when those companies don't know what the government's rules are until after they break them.

Yet ... Novartis isn't the victim here. While it's certainly the case that the FDA ought to pull its socks up and publish some rules, Novartis had plenty of warning that its Tasigna promotion was wrong.

The Novartis widget allowed Facebook users to insert a link to the Tasigna web site into their profiles. One of them looked like this:

• CML (Chronic Myeloid Leukemia)Treatment â€" Find out if Tasigna is Right for You | Tasigna (nilotinib)
  www.us.tasigna.com
  Tasigna (nilotinib) 200-mg capsules from Novartis is a next-generation treatment for Ph+ Chronic Myeloid Leukemia in adult patients in chronic or accelerated phase who are resistant to Gleevec.

Facebook is a new territory that the drug business would very much like to explore. Facebook would be perfect for gathering groups of patients and doctors together so they can share information and advice, especially for chronic conditions. But just because it's new doesn't mean there are no rules. The FDA has repeatedly made it clear that if a company is going to make a medical claim for a drug -- and all Novartis' Facebook widgets indicated Tasigna was a leukemia treatment -- then you have to balance that with a warning about the drug's risks and side effects.

It's a really simple rule to follow and yet somehow Novartis couldn't manage it.

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