EMDC

Late Friday Afternoon: FDA, Politics, and Scientific Integrity Steve Grossman starts: When my Smartphone delivered an e-mail at 5:12 p.m. on Friday: “FDA approv…,” I knew that FDA had just announced something controversial. All public relations people (including those at FDA) have been taught that late Friday is the time to release stories you don’t [...]

S. 510 – FDA Food Safety Modernization Act – The Small Farms and Businesses Assistance Act Bill Marler summarizes S.510, food safety legislation that passed the House last year and is making its way through the Senate now. The summary of the summary: USDA and FDA jurisdiction over foods remains unchanged Protections for farmers markets, [...]

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.

Government Health IT magazine talks about the first steps in FDA’s move towards greater transparency.

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.

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 [...]

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 [...]

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 [...]

“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.