Pharma struggling with social media
The FDA's recent warning letter to Novartis about a Facebook widgit has highlighted the challenge pharma faces in trying to
make effective use of social media tools without stepping on the toes of regulators.
The challenges posed by social media were discussed in Ernst & Young's recent Progressions: Pharma 3.0 report when analyst Ken Burbary explained that companies were already struggling to fit their consumer messages in 30second television
spots in the US. So, how could they possibly confine themselves to the limited characters of text required by Twitter and
Facebook? According to the US Code of Federal Regulations, promotional materials (other than reminder pieces) must disclose
risk and other information about the drug. "The disclosures required by the FDA on the risks and benefits of brandname drugs
can use up more than half, if not all, of the allotted space on these sites," said Burbary.
Indeed, this is where Novartis ran into trouble with Tasigna. The company had added a Facebook Share widgit to its Tasigna
website. When clicked on, the widgit generated Novartiscreated information for the drug that could be shared by being displayed
on a Facebook user's profile. Unfortunately for Novartis, the shared content didn't contain information about the risks. "The
shared content is misleading because it makes representations about the efficacy of Tasigna but fails to communicate any risk information associated with the use of this drug," said the FDA letter.
Although a blog from Pharmaceutical Executive (available at
http://www.pharmtech.com/peblog) said that this is the first known enforcement by the FDA regarding Facebook, it's not the first time that pharma has run
into trouble as it grapples with new web-based tools. In March 2009, the FDA's Division of Drug Marketing, Advertising and
Communications sent warning letters to 14 pharma companies because of sponsored links on Google. In response, paid search
advertisements for pharmaceutical brands declined quickly. According to Ernst & Young, both comScore and Advertising Age reported
the number of such advertisements had dropped by 84% by the end of June 2010.
(SCOTT DUNLAP/GETTY IMAGES)
Can it ever be regulated?
Even now, more than a year later, there are no specific regulations that address pharma's use of the internet and social media
tools, although the FDA did take the first steps towards this in November 2009 when it held a public hearing to discuss the
situation. According to the hearing, social media is more than just a trend and will play an even greater role in the lives
of consumers going forward. However, many pharma representatives explained that they were uneasy about using such tools because
of a lack of guidelines. In particular, companies were unsure about how responsible they were for monitoring the internet
for incidents such as inaccurate or off-label commentary.
A range of possible solutions were discussed, including the establishment of working groups to keep an eye on e-developments.
The FDA has said it will review all the information from the hearing, but to date there is still no word on any official guidance.
In its report, Ernst & Young also adds that one of the biggest questions will be whether regulators can establish and maintain
guidelines capable of keeping pace with the speed at which the internet is evolving.
For now, pharma's foray into social media has been understandably slow and Burbary adds that the industry's best move remains
"uncertain". He explained: "Some companies may choose to wait on the sidelines — a decision not as safe as it may seem — while
others may be willing to test the water in small pilot programmes that aim to minimise risk."
As for Novartis, the company was quick to remove the widgit in question, as well as all other social media widgits that used
to appear on the Tasigna page. However, the company hasn't been scared away from social media completely, as it still operates
and updates its YouTube channel.