EMDC

FDASM – “Everything about the FDA, Internet, & Social Media”
It’s an aggregator of information about the FDA, it’s use of social media, and it’s regulation of social media use by the industries it oversees.

Eye on FDA: What We Didn’t Hear at the FDA Part 15 Meeting on Social Media
We heard from far too few pharma companies, and far too many bloggers.
What was missing? What anyone should be doing in the meantime, what’s the process going forward, and what (if anything) is going on in Europe.

Rich Meyer says pharma marketers don’t even know what to do with the web traffic data they already have much less how to integrate social media into the mix, which is ironic considering how much research goes into pharma industry decision-making.

Federal Register: FDA Announcement of Social Media Hearing
[Federal Register: September 21, 2009 (Volume 74, Number 181)]
[Notices]
[Page 48083-48088]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21se09-58]
———-
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0441]
Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools; Notice of Public Hearing
AGENCY: Food and [...]

Common Sense Media Group: The 5 Myths Surrounding the FDA and Social Media
Must read. He takes a pretty pessimistic view. Basically, don’t expect FDA action any time soon and don’t expect any radical changes.
(via ePharma Rx)

Eye on FDA: What Companies Should Do Between Now and The Part 15 Hearing on Social Media
A good read all the way through. He has advice for individual companies and for industry associations. And this:
At the FDLI conference held earlier this week in Washington, both Dr. Janet Woodcock and Tom Abrams affirmed that this is [...]

AdAge: FDA to Hold Public Hearings on Big Pharma’s Social-Media Use
The U.S. Food and Drug Administration will hold a two-day public hearing in November on how pharmaceutical companies use the web and social-media tools to market their products, the first step in a long overdue process that will finally establish guidelines for how drug makers [...]

“Use of internet-based social media such as Facebook and Twitter can pose compliance risks for drug companies, experts agree.” — I’ll say this: Any time anyone who is employed by a drug (or device, or biotech) company opens their mouth, it’s a compliance risk. Regulated companies can and should use social media channels to market themselves instead of their products.

I was quoted in an August 7, 2009 St. Paul Pioneer Press article on foursquare, a location-aware social game in which you check in at venues around town to earn points and badges, to let your friends know where you are and potentially meet up with them, and to alert friends to hot tips about that place.

“A group of attendees heavy on public relations and drug company employees brainstormed about the possibilities of using social networking sites like Facebook and Twitter to get the word out about their products, or maybe about a particular condition, and connect with the end users: physicians and patients. There’s a big catch for drug makers, however. The Food and Drug Administration hasn’t really determined where these communications fit into its regulatory scheme.” — Biggest problem is they’re usually thinking of social media in terms of how can they market and sell, not how can they build relationships with doctors and patients. Expecting a bunch of senior executives to come up with a policy, when I’m pretty sure they’re not the most knowledgeable folks about the medium, is asking for… maybe not disaster, but certainly something ineffective and meaningless.