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FDA struggles with the new world of social media
That the Internet has become a valued source of medical information for prescribers and patients is not news. That it took until mid-November for FDA to recognize this in a meaningful way is exasperating, but the good news is that now the discussion is engaged.
In truth, there have been both positive and negative actions by FDA regarding consumer health information on the ‘Net. The positive: FDA initiated a relationship with WebMD a year ago (and renewed and expanded it in October) to post FDA information on WebMD’s site. “We see partners like WebMD as critical to helping us reach the public with important health information,” says FDA Commissioner Margaret Hamburg, adding that the effort has generated 150,000 visits over the past year. (Side note: while WebMD’s competitors might be grinding their teeth at this apparent governmental favoritism, they haven’t jumped to partake of it either, maybe because 150,000 visits is actually pretty meager. Meanwhile, some bloggers are questioning the appropriateness of accepting government information unmediated. Welcome to the upside-down world of the Internet!)
The negative: last spring, FDA’s Division of Drug Marketing and Communications (DDMAC) issued a warning that “single click” banner ads on websites, or the paid-for top rankings on Web searches, violated FDA’s fair balance rules by not including risk information. Several months later, Comscore reported that pharma Web traffic had nosedived as a result of pharma companies’ pulling back from the sponsored search.
This action, combined with a host of growing concerns and disputes over how drug information is disseminated on the Web, led to DDMAC’s Nov. 12-13 hearing in Washington, where a stream of invited speakers made their pitches both on what is happening on the Web, and what should be happening. Pharmas, trade associations, Internet companies, medical education experts and consumer advocates all made a cacophony of warnings and suggestions; DDMAC is accepting online comments until the end of February, and at some point thereafter will issue new guidance. (DDMAC last visited this topic in 1996—consider for a moment how things have changed on the ‘Net since then.)
There are serious, far-reaching problems with how the pharma industry can interact with consumers on the Web. When DDMAC restricted single-click advertising from pharma companies, the net effect was that consumers have fewer opportunities to access reviewed, approved information on drugs. Further, under current regulations, drug and device companies are required to report adverse events as they become aware of them, which opens up the possibility that armies of pharma workers will have to monitor every blog, discussion forum, content posting and rant found on the Web. Finally—although it’s not polite to mention this in a context of paramount concern for patient safety—Internet advertising represents a significant business opportunity for the search engines, content publishers and consumer-health forums.
As newspaper publishers, recorded music distributors and other content developers have found, the Web destroys just about any structure meant to limit access to content. Yet FDA (and many in the biopharma industry) would like to believe that the Web has accountability and can be controlled by some type of filter. In the current dynamic between the industry and FDA, the agency can police industry commentary with its fair balance requirements, and it’s easy to predict that FDA’s initial actions will be to form rules that fall heaviest on the industry. At the meeting, heavyweight online businesses such as Google and Yahoo proposed neat workarounds for the single-click restriction (essentially by allowing a banner or search result to contain both a content section and a risks section—but even that “parallel click” workaround was objected to by some speakers). But this policing will inevitably constrict validated information from pharma companies, while the torrent of unvalidated information will continue to grow.
There’s a fascinating parallel here with how drugs are physically distributed and sold—the so-called “normal” distribution channels like retail pharmacies and hospitals, and the unregulated world of Internet pharmacies that we’ve reported on here in the past. Most consumers, most of the time, are able to know when they are in one channel versus the other. Will it be possible to say the same about drug information on the Web?