tag:blogger.com,1999:blog-8550428.post8437303464424109789..comments2024-03-27T01:34:23.434-04:00Comments on Pharma Marketing Blog: Communicating Risk in Online Drug Ads: Reading the Tea Leaves in Recent FDA Draft GuidanceVladhttp://www.blogger.com/profile/04114063498108633047noreply@blogger.comBlogger5125tag:blogger.com,1999:blog-8550428.post-40479604729941563672009-06-01T12:55:35.292-04:002009-06-01T12:55:35.292-04:00Before people spend more time chasing the "re...Before people spend more time chasing the "reasonable man" ball, let's get clear about this. FDA is not talking about just any "reasonable man"; they specifically reference the "reasonable consumer" as described in the 1983 FTC Policy Statement on Deception. Please note:<br /><br />1) This is not a casual label that anybody can staple their own definition on.<br /><br />2) It does not require the MOST reasonable projection of what the "reasonable consumer" may say or do. Indeed, an interpretation that is held by merely a significant minority may still be considered "reasonable."<br /><br />3) When possible, the basis for that "reasonable consumer" should indeed be evidence based. And, the FDA Draft Guidance does cite its evidence basis. Apart from the usual assortment of usability studies, the base for consumer and HCP projections of "reasonable" is their own set of surveys, summarized in Aikin, Swasy & Braman: "Patient and physician attitudes and behaviors associated with DTC promotion of prescription drugs."<br /><br />You want to argue with DDMAC? Fine, they need arguing with. But first, do your homework, eh?Mario Cavallinihttp://www.rosetta.comnoreply@blogger.comtag:blogger.com,1999:blog-8550428.post-59667583659684640302009-05-29T20:03:09.249-04:002009-05-29T20:03:09.249-04:00Somebody should send the FDA a telegram and explai...Somebody should send the FDA a telegram and explain to them that times have changed. DDMAC's lack of guidance on the use of social media, and their knee-jerk reaction in sending warning letters to companies regarding Internet drug ads, smacks of a bureaucracy that is woefully overwhelmed. Perhaps a shift back toward a more collaborative realtionship with industry might serve them better. In the past, FDA worked more closely with industry, and more seemed to get done. Funny that.David Avitabilehttp://www.jfkhealth.comnoreply@blogger.comtag:blogger.com,1999:blog-8550428.post-2704104794146076642009-05-29T11:13:24.219-04:002009-05-29T11:13:24.219-04:00John,
I like this. Good analysis! I think you a...John,<br /><br />I like this. Good analysis! I think you are right on with respect to the reality of FDA's thinking and a "reasonable" and practical intepretation of the guidance. I believe, indeed, you're on target with how FDA (at least DDMAC) is thinking about this.<br /><br />I think Arnie's thinking and approach is also "right on" however. In spite of your realistic perspective on how FDA will interpret the "reasonable man" standard, FDA (contrary to certain public opinion and perhaps to opinions of certain FDA officials themselves) FDA is not omnipotent and is not sole and ultimate arbiter of truth, reasonableness, or of correct interpretation of the law. There are many degrees of reasonableness, and many variations of form on what an advertisement or labeling can be, particularly on the internet, and Arnie is "dead on" in his critique. While FDA may use social science and market research to support its policies or general perspectives on enforcement issues, in the end a single enforcement case presents unique circumstances. In any case, in an individual enforcement situation the "reasonable man" (or woman) is a sample of one or perhaps a few people in DDMAC (who often themselves disagree). FDA's enforcment actions are not (and will not be) substantiated by research into the reasonable men and women who are actually the target audience of the ad (or any research sample at all). <br /><br />Are you a "reasonable man"? Do you disagree with people now and then? Do you disagree with DDMAC now and then? <br /><br />Arnie's, and others', pursuit of this issue (among others) is very important in spite of the current realities that you articulate. I think, by the way, that there are lots of other issues with this guidance that also need to be pursued in dialogue with the FDA. For instance, this guidance leaves little room for any innovation to actually improve risk communication in advertising or promotion. Ironically, it simply solidifies the current communication model with more restrictions, a model that so many stakeholders are dissatisfied with. At best, we can expect improvement in compliance, but likely not improvement in risk communication (these are, in many ways, independent).<br /><br />By the way, this is what you get when you ask for guidance from FDA, and for perspective, this guidance (even though sorely needed perhaps more than any other topic, including internet and social media) has been in the works for years and years and years and years. Hopefully, the new administration will fix the timeliness of guidance and rulemaking (which it has said it intends to work on).<br /><br /><br />John MurrayJohn Murrayhttp://www.goodreprintpractices.comnoreply@blogger.comtag:blogger.com,1999:blog-8550428.post-89264097484763243262009-05-29T10:12:59.930-04:002009-05-29T10:12:59.930-04:00Don,
Can't agree with you more. Maybe Arnie Fired...Don,<br /><br />Can't agree with you more. Maybe Arnie Firede's coalition will work on "Guidance for FDA on Regulating the Internet" that they can comment upon in a public forum!PharmaGuyhttps://www.blogger.com/profile/10211557578124130640noreply@blogger.comtag:blogger.com,1999:blog-8550428.post-3027870740954932732009-05-29T09:55:45.902-04:002009-05-29T09:55:45.902-04:00The one thing I can't understand about all of this...The one thing I can't understand about all of this is why the FDA won't address the internet.<br /><br />Is it because of lack of understanding or lack of resources or maybe something more sinister that someone may be holding them back because they don't want this can of worms opened up.<br /><br />The pharma industry has so much money and so much distrust from the public but yet they can't converse (notice that this is different than shouting at us on TV) with the public that really needs to speak with them. They need the transparency that the internet offers.<br /><br />The funny thing is a lot of internet marketers are probably upset over this new "draft" info and how they can't effectively use Google Adwords or banner ads. <br /><br />Big deal.<br /><br />If you want something that really works, you need to be using social media and speaking directly to your customers. Maybe you can use some of the wasted funds that you were dumping into Adwords and start hiring smart, sympathetic people that can represent your brand in an authentic way online and help people (not just paying them to praise you!!!!)<br /><br />It's a whole new world out here in marketing and consumers are more in control than ever. And that is the way it should be.<br /><br />Pharma and FDA need a task force to address this right now and if the FDA doesn't have the manpower, pharma should form a coalition on their own and come up with fair regulations for online engagement. This is too important to wait any longer.Don Schindlerhttp://www.mediasauce.comnoreply@blogger.com