Drugmakers must allow visitor comments on Facebook pages
■ Some companies deleted their sites after the policy change, citing no FDA guidance on whether adverse drug events posted on social media must be reported.
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Some pharmaceutical companies shut down Facebook pages, while others monitored and deleted visitor comments, after the social media site on Aug. 15 stopped giving drug companies the option of preventing public comments on their pages.
Facebook had allowed pharmaceutical companies to request that their commenting features be turned off, which many took advantage of because of confusion about whether the Food and Drug Administration would require companies to report adverse drug events disclosed on social media. Physician and hospital Facebook pages have not been allowed to disable comments.
In April, however, Facebook sent letters to pharmaceutical companies indicating that beginning Aug. 15 they no longer would allow the companies to disable the comment features on pages associated with the drugmakers, with the exception of pages for individually branded drugs.
As a result, some companies, including Johnson & Johnson and AstraZeneca, which have multiple Facebook pages, shut down some of their pages. Novartis removed all of the content from its Facebook wall and posted a note saying the page is being redesigned "to align with new Facebook policies." Others, such as Pfizer and GlaxoSmithKline, now open their sites with a splash page detailing its policy on comments, including why it would delete them.
AstraZeneca U.S. spokesman Tony Jewell said the company will maintain its corporate Facebook page, AstraZeneca US Community Connections. "We strongly believe in using social media to engage with stakeholders. We regularly evaluate the most effective channels available for our use, in keeping with our regulatory responsibilities."
Johnson & Johnson posted a message on its website that said the majority of its more than 60 Facebook pages were not affected by the change because they already allowed comments. But it decided to shut down several unbranded pharmaceutical pages because "the new policy altered functionality in ways that changed the ability to sponsor some pages due to regulatory, legal and other considerations."
Legal gray area
Social media experts say that with no specific guidance from the FDA on how to handle social media comments about individual drugs, keeping a Facebook presence might be a legally troublesome activity.
Drug companies that continue their presence on Facebook "may be at future risk until the FDA gives an official ruling on whether customer comments on corporate social media pages can be interpreted as 'medical advice' or other types of positive or negative medical endorsement," said William J. Ward, PhD, professor of social media at the S.I. Newhouse School of Public Communications at Syracuse University in New York state.
Scott Kiekbusch, director of user experience at Digital Influence Group, a digital marketing agency that specializes in social media, agrees that pharmaceutical companies have reason to be cautious. But he thinks if they are on social media, they should be involved in an open dialogue that has set parameters of what is appropriate.
"If an organization is unwilling to have a dialogue with patients, caregivers and health care providers, they should seek alternative marketing channels," Kiekbusch said.
Shelly Burgess, spokeswoman for the FDA, said developing guidance and policy regarding the promotion of FDA-regulated medical products over the Internet and social media is "among our highest priorities." But she said providing a time frame on when the FDA will release them is difficult due to the extensive work and review process involved. The agency began meeting with stakeholders on the issue more than two years ago.
FDA guidance from 1997 on disclosing adverse drug events states that for companies to cite an adverse event, the reporter must have an identifiable patient, an identifiable reporter, a specific drug or biologic involved in the event, and an adverse event or fatal outcome.
The FDA guidelines say that an event does not need to be reported if one or more of these elements is still missing "after being actively sought by the applicant, manufacturer or licensed manufacturer."
Little identifying information
A 2008 report by the Nielsen Co. looked at 500 health care-related messages posted online. Only one contained all four of the reporting requirements, but 56 messages (11%) contained enough identifying information that the companies could have reached out to collect more data for an adverse event report, Nielsen said.
Mark Rogers, founder of Market Sentinel, a British-based online monitoring and analytics firm that has analysts in the United States, said he interprets the guidance to mean pharmaceutical companies are under a legal obligation to report adverse events to the best of their ability, including using Facebook profiles to identify the person making the claim.
He noted that pharmaceutical companies have a broader -- but nonlegal -- obligation to maintain a reasonable dialogue with stakeholders, including physicians, patients and disease advocacy groups, which is why many created Facebook pages in the first place.
Many pharmaceutical companies on Facebook that allow public comments have disclosures warning users that inappropriate remarks will be deleted. Included in the inappropriate category are reports of adverse effects and events as well as medical advice. Rogers said the company has the right to delete any comments it wants, but after it has met its reporting obligations.
Faith Busch, spokeswoman for Boehringer Ingelheim, which kept all of its Facebook pages active after the new policy went into effect, said the company had its guidelines for Facebook postings established well before the changes were made. She said all online comments found by Boehringer employees that meet the adverse event reporting criteria are reported. This includes those found on other channels.
"The fear of being penalized for consumer comments on social networks goes beyond Facebook," said Syracuse's Ward. "Comments on other social networks like LinkedIn and Twitter have similar potential risk for pharma until the FDA provides a definitive ruling on this issue."
At the least, monitoring and deleting comments can create ill feelings for companies that keep a Facebook presence, including a series of comments on GlaxoSmithKline's page demanding to know why previous comments were erased.