After several years of anticipation, the FDA has finally proposed a pair of guidelines for how drug and device makers should cope with some of the challenges and pitfalls posed by social media.
One of the so-called draft guidances offers instructions on how companies should attempt to correct product information on websites that are run by others, such as chat rooms. The otheraddresses how products – including risk and benefit information – can be discussed in venues such as Twitter, as well as paid search links on Google and Yahoo, all of which have limited space. This will involve using links to product web sites, for instances, that can be clicked.
“These are intended to have a beneficial impact on public health,” Tom Abrams, who heads the FDA Office of Prescription Drug Promotion, tells us. “But these were not developed in a vacuum. They were developed with careful consideration and with input from industry and many other stakeholders. There was a lot of important consideration given to the issues.”
For third-party websites, such as Wikipedia, the draft guidance suggests that companies should feel free to correct misinformation, but that any correction must include balanced information and the source of the revision or update must be noted, Abrams explains. This means a company or company employee or contractor should be credited with any additions.
“The information should not be promotional and should be factually correct. This is not an opportunity for a company to tout its drugs,” he says. “The information [being added or revised] should be consistent with the FDA-approved [product] labeling and for it to be effective, you want it posted right by the misinformation.”
The guidance also says that companies should contact writers, such as bloggers, to make changes when they learn of misinformation. Abrams notes companies will not be held responsible for those who do not make changes. If none of this is possible, he says companies should contact web site operators and suggest they delete the misinformation or open the site to comments so that corrections can be made.
The guidelines are being released nearly five years after the FDA held a well-attended public hearing to sift through Internet issues confronting drug and device makers. But the guidelines never materialized, despite repeated signals they may be forthcoming. Now, FDA officials must act before a July deadline set by a 2012 law requiring them to release guidance on product promotion on the Internet.
In the interim, the lack of guidance has vexed companies. Some have cautiously embraced social media, but others have largely shied away over concerns the FDA may scold them for violating promotional rules. In fact, among the 50 largest drug makers, half are still not using social media to engage consumers or patients, according to a recent survey by IMS Institute for Health Informatics.
“Since that 2009 meeting, there has only been partial insight,” says Mark Senak, a senior vice president and partner at the FleishmanHillard public relations firm that works closely with drug makers, and who also writes a blog called Eye On FDA. “And we’ve needed clarity because pharma is unsure of the parameters. People need to know the guideposts.”
For instance, some drug makers have instructed their employees not to communicate on third-party web sites, where opinions are frequently offered and information is swapped. The reasoning is fairly simple – there is concern that any interaction or changes introduced could later prompt the FDA to accuse the company of inappropriately promoting a product.
The guidances, however, are unlikely to be the last word. For one, the FDA will allow for a comment period in which still more input can be gathered before finalized versions are released. Moreover, FDA officials will use the guidances as trial-and-error blueprints themselves as they run across questions that were not answered or situations that may not have been anticipated.
“For the FDA,” says Senak, “it’s a process, not an event.”
Source : http://blogs.wsj.com/pharmalot/2014/06/17/tweet-this-fda-finally-proposes-social-media-guidelines/
