By Barbara Ficarra, RN, BSN, MPA with David Harlow, Esq.
This is the second part of a three part post addressing the legal concerns of social networking in the health care arena.
Legal expert, David Harlow, Esq., Health Care Attorney and Consultant at The Harlow Group, LLC in Boston, address the issues.
What Steps can Pharma Take to Engage in Social Media?
Q: Barbara: After speaking at a recent pharmaceutical conference, the pharma industry is concerned with the legal implications of social media; and it appears that pharma is waiting for guidelines from the FDA. David, what steps can pharma utilize to engage in social networking without specific guidelines from the FDA?
A: David: Pharma companies are, for the most part, extraordinarily risk-averse, and reasonably so. They live in a heavily regulated environment, and a misstep can have potentially disastrous consequences in the form of sanctions imposed by the FDA and the attendant negative publicity. Pharma is concerned about being able to provide “fair balance” in social media, about the possibility of having users post information about adverse events that would be reportable to the FDA (though research has shown that only about 1 in 500 AEs posted via social media are in fact reportable AEs, and the leaders in this arena all say that they would rather learn about AEs sooner rather than later in general – the challenge is finding the resources needed to monitor adequately). That said, there are some pharma companies that have decided they can structure an approach to social media that is compliant with FDA requirements. There are guideposts that must be observed in all communications by pharma companies, and while social media tools are different in kind from the channels that have come before, we should be able to take a commonsense approach to extrapolating from past rules and regulations, and warning letters, and the like, in order to plan for appropriate efforts to engage the public via social media. In particular, pharma companies that are successful in this sphere have brought together communications, legal, regulatory and compliance folks, and have come up with guidelines for different sorts of interactions. Thus, for example, a blog post does not require a six-week review before it is posted if it is within the in-house guidelines’ “green zone.” For now, most pharma social media is limited to unbranded communications, though there are a number of companies using Facebook and Twitter to put across their messages in a controlled manner that remains compliant with the law.
About David Harlow, Esq.
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As always, thank you for your valuable time.