Facebook and Pharma – an Uneasy Alliance
By Ann Neuer
September 19, 2011 | On August 15, 2011, Facebook implemented a change in policy that redefines the ground rules for the pharmaceutical industry’s use of this popular social medium. As of that date, pharma companies no longer have the privilege of disabling comment walls on their company-sponsored Facebook pages. The inability of consumers to post or view comments had been a special accommodation from Facebook to the pharmaceutical industry, but no more.
With the new policy in place, the public can comment freely on Facebook pages targeting specific diseases and patient communities, just as they would on any Facebook page*. The issue for pharma is—what are their responsibilities if consumers comment on adverse events? Will companies have to be constantly policing their sites in search of potential adverse events (AEs), and then report them to the Food and Drug Administration (FDA)? Companies also wonder if this new freedom for consumers will attract additional scrutiny from regulators looking for any hint of an AE.
Elizabeth Garrard
According to Elizabeth Garrard, Chief Safety Officer at Drug Safety Alliance, a provider of pharmacovigilance and risk management services, reaction from the pharmaceutical industry is all over the board. “It’s a mixed bag. An amazing number of pharma companies have decided to leave the comments open and just address them. They’re putting more resources on this through increased staff and they will have to put tight policies in place. Others are just folding up their camp because their risk tolerance doesn’t allow them to do this, so they are taking down their pages,” Garrard says.
Recent stories in the media support Garrard’s observations. They indicate that some company-sponsored Facebook pages have been removed or revamped to the point that they are little more than shorter versions of their Web sites. Other companies are going with the flow and are accepting the interactive nature of social media.
The key issue for companies centers on the lack of guidance from FDA as to how pharma should respond to a posting that could be an AE. If an AE is described, it would have to be reported to FDA, but first, a company would need to determine that a posting actually qualifies as an AE. As described in a 2001 FDA draft guidance, there are four criteria: there must be an identifiable patient; an identifiable reporter of the AE; a suspect drug or biological product; and a suspected adverse experience or fatal outcome.
Meeting these criteria presents quite a challenge as companies may struggle to identify who the patient is, the dose, or other medications he or she is taking. This effort is made all the more difficult in the absence of FDA guidance.
Over the past year, there had been expectations that one or more guidances describing pharma’s responsibilities related to social media might be imminent, but thus far—nothing. The Division of Drug Marketing, Advertising, and Communications (DDMAC) within FDA has put forward a statement describing the development of multiple draft guidances on social media promotional issues as one of its highest priorities. DDMAC’s own research on the subject coupled with information gathered from a widely attended public meeting held in late 2009 has led to the identification of six areas of interest, but no timeline for the release of guidances.
When eCliniqua contacted FDA to ask which might be the first guidance to be released, we were told, “We can’t answer this question.”
In the interim, there are some available tools. Glenn Byrd, Senior Director, Regulatory Affairs, MedImmune, points to existing guidances from DDMAC on how to present risk information and promotion. Although these do not deal specifically with social media, Byrd explains, “We already know what the basic rules of promotion are—truthful, non-misleading speech, a balanced presentation of risk and benefits, and the revealing of material facts so people know who a product is for. This starts to paint a boundary and it’s what guides us in the absence of social media guidance.”
Although some companies are becoming increasingly conservative in their use of interactive social media until FDA provides guidance, it is not clear how many will completely opt out. It is noteworthy that at this time, FDA has not chastised a single company for how it is handling public comments, so with millions of users of social media worldwide, it would seem unwise to ignore this major phenomenon. As Byrd points out, “The main reason why companies are interested in using social media is its reach. The idea of people engaging each other is pretty powerful. You go where your markets are and social media is part of a natural evolution of how best to communicate.”
*The new Facebook policy does not apply to pages dedicated to specific prescription products.
