A ray of hope out of Tasigna DDMAC letter

August 6, 2010 – 10:07 am by Chris

At first glance, the letter from FDA’s DDMAC about Novartis’ Facebook Share widget for the cancer drug Tasigna seems to be a case of the regulatory agency being digitally backward.

But not so, says Bruce Grant, senior VP of business strategy at Digitas Health. He argues that FDA wasn’t making a statement about social media, but on the information Novartis crafted to share with the Facebook Share widget.

“Our own take on this is not as gloomy as the initial response has gone. There’s actually a few things to be pretty encouraged about, for those looking for a real view from FDA, vis a vis social media,” he says.

If the regulatory agency was intent on doing what a lot of people in the industry had feared – that is, making pharma manufacturers responsible for other people’s online comments about their products – this was the opportunity for FDA to do. “And they pointedly declined to so that,” Mr. Grant points out. “We take this to be a reasonably strong statement, as far as signals we’re going to get in advance to issuance of the guidance., that FDA is going to focus on what the statute says its responsibility is, which is to regulate what industry says and does,” he says.

The action did send a strong statement about FDA’s stance on one thing, Mr. Grant says, “For those who continue to cherish the hope that FDA might be persuaded to adopt a one-click rule, to reverse itself from the position it took a year last March in the famous 14 letters, I think this gives a pretty strong signal that the one-click rule is as dead a Generalissimo Franco – and not unreasonably so,” he says. “Their point, and it’s a pretty straightforward and reasonable point, is that the content that is generated on the user’s page, when they use the share functionality, is content whose form is close to 100% under the control of the pharma manufacturer, and therefore, it should be considered by the same standards that any other communication is. If it mentions the product, it has to mention both the brand name and the generic name as well as the complete indication as well as the material with information – the important safety information. It’s not an unreasonable position to take.”

Mr. Grant believes that Novartis “made it harder on itself” by omitting the material risk information and the important limitations on the indication. “If I had been there behind the curtain whispering in this particular client’s ear as to what their initial foray ought to be, in terms of incorporating Facebook Share functionality, I think I might have suggested to them that less complicated product, one that had a less complicated indication, with fewer significant limitations attached to it, and perhaps one with less risk information attached to it, might have been a better choice to test the waters in terms of doing that,” he says.

“There’s no new regulatory ground in principle being charted here, this is significant merely in that it is the first action take directly related to a social media vehicle,” he adds.

The lesson for all of pharma, in short? Make sure that even within the space limitations of a Google search result, a Tweet, or a Facebook Share Widget, that the information complies with present FDA statutes, and don’t expect the regulatory agency to create special rules just so the industry can work more easily within the limitations of Internet tools.