Pharma and social media and FDA: what the agencies are saying

November 5, 2009 – 11:04 am by Chris

It’s one week until the FDA hearings on pharmaceutical promotion and social media, and the chatter on the Tweet stream has turned into a frenzied roar. During the hearings themselves, the Tweet stream may actually be quieter, since it’s been reported that the hearing room itself is in a building without WiFi and even a good cell phone connection will be spotty. But individuals who are presenting at the hearing, such as John Mack at the Pharma Marketing Blog and Jon Richman at Dose of Digital are sharing at least parts of their presentations before the big day.

Some of the largest healthcare advertising agencies and networks – including McCann Healthcare Worldwide, Sudler & Hennessey, Ogilvy Healthworld, Grey Healthcare, CommonHealth, Euro RSCG Life, and Cline Davis Mann – have collaborated with the American Association of Advertising Agencies and the Coalition for Healthcare Communication to put together a presentation. You can read it here.

The presentation will actually be given by John Kamp, an attorney at Wiley Rein and the executive director of the Coalition for Healthcare Communication. Reading it, I see they’ve come up with a new acronym for us: FRI, or “FDA regulated information.” The pharmaceutical industry and the agencies want to fight “widespread Web healthcare inaccuracy and fraud” and work with FDA to set standards for FDA regulated information. The idea is that, “robust FRI would support legitimate sites, easier browsing by professionals and consumers and better information supporting public health.”

Establishing a standard for FDA regulated information and being able to designate sites as having FDA regulated information would help “professionals and consumers … recognize sites, networks designed to offer authoritative, accurate information”; “visitors would know industry promotion is overseen by FDA”; and “would create ’safe street’ alternatives to sometimes ‘unknown street’ environment.”

The coalition also says FDA, CDC, CMS, and the FTC need to coordinate efforts to combat “false, dangerous information” and provide “quick, visible enforcement.” I know the industry is frustrated about the information distributed by the quack shillers of dubious herbal and other medicaments, but so much of this information is passed on from person to person in places such Tribe.net, where there are more than 2,000 forums devoted to health and wellness. There are vendors of alternative medical services and goods, but most of it is well-meaning people giving advice such as this (how to “naturally” combat MRSA with something called usnea). And the participants are not just the United States, but around the world. How an interagency effort can even begin to touch stuff like this, I have no idea.

The main point made by the industry in the coalition’s presentation, however, is that FDA must consider site control, not content, in its regulation of industry information. This seems to point the FDA away from clubbing pharma companies for Sidewiki-contained information, since these companies cannot control who puts up a Sidewiki on their sites.

In the end, the FDA will take all of the information presented and come up with guidelines the industry can live with. Or it won’t. But seeing the runup to the hearing continues to be interesting.

Tags: FDA, hearing, Social media