Social Media Guidance and the Art of Patience

The FDA recently gave Novartis a slap on the hand for "misusing" the Facebook Share widget on its website for the drug Tasigna. The violation? Failing to communicate risks associated with the drug.

The Facebook Share widget gives Facebook users the opportunity to share content by generating a link on their profiles to the information alongside a thumbnail image and brief description of the content. In the case of Tasigna, the drug's brief description made no mention of the drug's risks.

Should Novartis be blamed for this oversight? Maybe so - the FDA does make the communication of risk information associated with a company's drugs a requirement in all other facets of media - but this could have been avoided had the FDA provided the industry with clear, no-nonsense instructions on what rules apply to social media.

Some in the industry are asking for increased guidance in an attempt to use their social media channels responsibly according to regulators. Back in March, AstraZeneca issued a proposal to the FDA outlining key principles and a draft regulatory framework for the use of social media. The company remarked that "without guidance, our activities are limited in a manner that we believe is not in the best interests of informed health care decision making." This proposal came as a response to the FDA's November 2009 hearing on social media, after which it was understood that the regulatory body would release new guidelines the following year.

Others, however, are proposing a different tactic: First Amendment rights. Pfizer and the Washington Legal Foundation filed a brief with a U.S. District Court in March to uphold First Amendment rights by limiting the FDA's authority on barring free speech of drug manufacturers on social media sites. Acting as an injunction against FDA enforcement action, this move is sure to delay further short-term progress in the form of FDA guidelines this year.

I can't say which tactic is smarter at this point - what I can say is that I don't believe guidelines should be issued as quickly as possible. Given enough time, the FDA will be able to formulate fair guidance over social media based on historical analysis and increased insights into the chain of online information. If this process is rushed, the industry will continue to chastised over individual cases that were not covered clearly under issued guidance.

In the meantime, learning from others' mistakes by closely monitoring warnings from the FDA directed at peers is a worthwhile short-term strategy.

References:
(1) Krigman, Eliza. FDA Tightens Reign on Social Media Practices. 9 Aug 2010.
(2) Fierce Biotech. AstraZeneca Outlines Principles for Product-Related Online Communications. 2 Mar 2010.
(3) WLF Press Release. 31 Mar 2010.