I tweeted about this a few times over the past few days, but if you don't follow Twitter you may not have seen it. And since I've highlighted a lot of FDA social media and DDMAC enforcement topics on this blog in the past, I felt it was pretty important to link to the story here as well. The below link has the story laid out in a nice color PDF "report":
I recommend you read the report, since its full of insights about DDMAC's approach and activity in regulatory enforcement, gleaned from an apparent interview with DDMAC Director Tom Abrams. But if you're short on time, here are a few of my key takeaways:
- FDA is reporting it is still on track to issue guidance on the Internet and social media in 2010.
- According to DDMAC Director Tom Abrams, FDA will develop "separate guidance that are issue-specific and can apply to the various mediums used on the Internet."
- Reuters explained that FDA will advise companies how to respond when consumers make an unprompted request for information on a drug.
- FDA is behind in a number of ways: keeping guidance and processes on par with advances in technology, as well as being short on resources. As the article and FiercePharma point out, FDA has only 57 staff to review 75,000 promotional pieces. They can't get to them all, so they have to prioritize.
- Considering, according to the article, FDA has "insufficient staff and antiquated technology systems," their existing reviewers and letter-writers have still found the time to stay very busy. For more background on their 2010 letter-writing campaign, see Mark Senak's analysis here.
- Stories like this remind me of one of the reasons I became disillusioned with public relations: media bias. The story really focuses on the notion that "... consumer advocates, some lawmakers and others see the barrage of [DTC] ads as a way to push medicines that people may not need as well as raise the nation's overall healthcare costs." The story goes on to highlight all the shenanigans the pharma industry has apparently been trying to pull over on consumers, citing blogger outreach, celebrity endorsements, and social gatherings as examples.
- One-sided stories like this one, combined with the onslaught of FDA letters, are definitely not helping Big Pharma's reputation. More on that later.
- Since the report was published Friday, many have weighed in with comments. Read them for a harsh reality check on how people view the pharma industry and DTC marketing. You might even consider posting a comment with your perspective.
- DDMAC Director Tom Abrams uses Facebook. I wonder if he'd be my friend?
1 comments:
Thanks for this review, Wendy - your bullet points are a helpful summary of the Reuters piece. I agree the report is worth a read - if only to be reminded of the media 'angle'. It's a shame that important points about the FDA's processes are tucked away behind a rant about pharma marketing.
I also agree that the comments are interesting - the general tone of comments on this piece are about pharma's DTC marketing model in the US. Of course that's what the discussion should really be about, not about social media as a channel per se. The important thing to discuss is how pharma engages consumers. Regulatory and pharma guidelines about engagement are the key issue. Social media just happens to be a current channel where engagement takes place in a faster and more personal, targeted way than before. I'm sure the FDA also understand this.
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