Social Media Rx for Drug Safety

An industry group representing pharmaceutical companies is proposing that the Food and Drug Administration require a FDA-certified emblem -- akin to the Good Housekeeping seal -- on Web content that contains medication information.

The so-called universal safety symbol, perhaps an FDA logo that links to more comprehensive information, would assure Internet users that the page they are viewing contains accurate drug risk data. Such a symbol could easily fit into Web services that limit word length, such as search results or the blog-broadcasting tool Twitter, says the Pharmaceutical Research and Manufacturers of America (PhRMA).

PhRMA is presenting the concept to FDA at a Thursday and Friday hearing on ideas for regulating the promotion of prescription products using the Internet. Currently, there are no specific rules on prescription advertisements or descriptions that post to the Internet. But all promotional materials for FDA-regulated products, wherever they may appear, are still regulated.

"Social media tools offer an unprecedented opportunity for third parties to speak about a sponsor's products without the knowledge or control of the product sponsor," says Jeffrey K. Francer, PhRMA assistant general counsel.

The association argues that manufacturers only should be accountable for pages that it controls, not sites like Wikipedia, an online encyclopedia that anyone can edit. The site includes many entries describing marketed drugs with information on the history of the treatment, FDA-approved uses, press coverage and investigational research.

"While some of the entry's content may repeat the sponsor's own labeling or advertising, Wikipedia users can alter this content and post additional information," Francer says. "As a result, the final Wikipedia page may - through no fault of the sponsor - fail to comply with FDA advertising and labeling rules were the page attributed to the sponsor."

Jay Walsh, a spokesman for the nonprofit Wikimedia Foundation, which operates Wikipedia, said in an interview that experienced editors remove content that is not attributed to existing research. For example, Internet users will notice and delete side effects in an entry that are stated as fact without a citation.

"One of the basic principles of Wikipedia is that we don't permit introduction of original research," he said. "Most Wikipedians default to a reductive editing process rather than an additive one."