Wednesday, March 10, 2010

PhRMA:Pharmaceutical Research and Manufacturers of America, transcript FDA regulation of social media: Universal symbol

Read the 8 page pdf transcript HERE.

A meeting with and for reporters and bloggers regarding concerns over social media for pharmaceutical companies and the FDA asking the FDA to approve a universal symbol (seal of approval).

Would you trust it, just because the FDA approved it? they approved Seroquel, Avandia, Saphris, Fanapt, Zyprexa, Vioxx......
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Snippets from the transcript: March 2010

"Because of the high interest in the FDA’s regulation of social media, we’d like to limit our questions to just that topic. And then finally, when the call is opened to the question-and answer period, please begin with your name and your media outlet or blog. Thank you very much. Now I’ll turn the call over to Jeffrey Francer. He is PhRMA’s assistant general counsel." --page 2

"The FDA’s leadership on this topic is essential. Today, more than half of adults first turn to the Internet to find health information. And regrettably, sometimes the information they find is unregulated and erroneous. PhRMA is proposing that the FDA issue new guidance detailing how biopharmaceutical research companies may responsibly use the Internet and social media.

I’ll briefly highlight our top three proposals before taking your questions. First, a universal symbol: The FDA should develop a single universal symbol that would in a single click take users directly to pages displaying FDA-regulated risk-and-benefit information about medicine.

The use of the FDA’s own logo or another FDA-approved symbol would shine a brighter spotlight on official Web sites of FDA-approved medical products containing regulated, comprehensive information about the benefits and risks of medicine. This symbol would also serve as a reminder that all medicines carry risk."- page 2

"MR. FRANCER: Sure. Well, right now, as you know, the FDA and the White House
and the Department of Health and Human Services all use the microblog Twitter as a way of providing newsworthy information using new media.


The FDA in particular, I think, has set a good example of the use of Twitter to broadcast I think what they believe to be newsworthy events, such as new drug approvals. And we provided an example of the FDA’s use of Twitter in our comments on page seven.

We believe that the agency should allow manufacturers to microblog about significant
scientific or regulatory events. Right now, there are no standards – no Internet-specific standards– on how manufacturers can use these media, and therefore, there’s some confusion.

There is some scientific exchange and some news exchange that is not promotion. And
the FDA should provide standards to help manufacturers differentiate between what information would be considered promotion and what information would be considered scientific exchange.

That’s the sort of standard that we’re asking for."--page 6

AND

"With respect to the FDA’s resources, PhRMA has continued to support a strong and well financed FDA. In the last PDUFA round, as you know, PhRMA supported the user fee that would have helped FDA to review direct-to-consumer television ads in a timely way. We’d have to look at any proposal for continued funding or user-fee funding for DDMAC, but we have supported – we have supported user-fee fundings to help DDMAC do its job in the past."--Francer, from Pharmaceutical Research and Manufacturers of America (PhRMA)--page 8

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Oh yes, a strong and well-financed FDA. That's what we need as a public watchdog for drug safety.

BTW, I found this pdf on TWITTER! Go HERE to vote on a universal symbol

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