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	<title>Xperience This! &#187; FDA</title>
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		<title>Message to FDA: Don&#039;t Interfere with the Experience</title>
		<link>http://www.misicompany.com/xdblog/index.php/message-to-fda-don%e2%80%99t-interfere-with-the-experience/</link>
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		<pubDate>Wed, 18 Nov 2009 20:48:58 +0000</pubDate>
		<dc:creator>Alejandra Diaz</dc:creator>
				<category><![CDATA[Experience Design]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Social Media]]></category>
		<category><![CDATA[User experience]]></category>
		<category><![CDATA[pharmaceutical industry]]></category>

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		<description><![CDATA[We wanted to demonstrate how patients', caregivers', and physicians' needs and perceptions shape the experiences they seek when they interact using social media tools. We further wanted to note how core experience design principles can help address questions being asked regarding how pharmaceutical companies should handle key information when interacting with their audiences in the social media space. 
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			<content:encoded><![CDATA[<p>Kathleen Fourte (MISI XD group EA) and I attended the Food &amp; Drug Administration’s Public Hearing on the <em><a title="FDA Public Hearing Site" href="http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm184250.htm" target="_blank">Promotion of Medical Products using the Internet and Social Media Tools</a></em>.  MISI had insights to share from countless contextual inquiries and usability tests with patients, caregivers<span style="color: #008000;">,</span> and physicians (both primary care and specialists).  We wanted to demonstrate how these people’s needs and perceptions shape the experiences they seek when they interact using social media tools. We further wanted to note how core experience design principles can help address questions being asked regarding how pharmaceutical companies should handle key information when interacting with their audiences in the social media space. <span id="more-156"></span></p>
<p>The principles we spoke to during our 14 minute testimony are familiar to anyone in the experience design, interaction design or usability industries. </p>
<p>1)     Put Your Audience in the Driver’s Seat</p>
<p>2)     Speak Your Audience’s Language</p>
<p>3)     Design to Support the Task, Not Become the Task</p>
<p>4)     Provide a Clear Navigation Structure</p>
<p>5)     Mimic the Real World</p>
<p>6)     Be Consistent and Follow Platform Standards</p>
<p>7)     Keep It Simple</p>
<p>8)     Be Flexible and Efficient</p>
<p>9)     Engage Your Audience</p>
<p>10) Support Your Audience and Give Feedback</p>
<p>These principles ensure that the Audience (the “User”) is kept at the center of design at all times.  We were able to apply these principles to a few concrete examples of how it should look when an FDA-regulated pharmaceutical industry is engaging in social media. </p>
<p><strong>The Hearing</strong></p>
<p>Throughout the hearing there was a lot of defense of Pharma’s place in the social media dialogue.  This included testimony that factual information provided by pharmaceutical companies can benefit people looking for answers in the Wild West of online information.  One point we made that seems to have resonated with people in the industry was not around <em>whether</em> companies should be able to share product information, but rather, <em>how</em> they can do it without interfering in the dialogue that is inherent to social media.  For example, we noted that product information should be kept separate from the dialogue, perhaps not even on the same page, where it can potentially disrupt the dynamic content that people want and expect when engaging with others in a social forum – <em>Design to Support the Task, Not Become the Task</em>. </p>
<p>With regards to Important Safety Information (ISI), one of the hearing’s major concerns, we used the design principles to guide options as to how ISI can be displayed when pharmaceutical companies participate on various social media platforms.  First and foremost, being <em>Flexible and Efficient</em> comes into play because different social media have different inherent qualities and limitations.  For example, ISI traditionally appears at the bottom of a standard web page where people have come to expect it (<em>Be Consistent and Follow Platform Standards</em>). However, if this placement isn’t possible, as when posting a comment on a page or board that is not sponsored by the company, ISI should be included via a link.  It’s critical when doing this to be mindful that people will not do something unless motivated; so companies must make sure the audience understands what the link is for and include appropriately descriptive text.</p>
<p>You can check out a PDF of our presentation deck here: <a href="http://www.misicompany.com/xdblog/wp-content/uploads/2009/11/MISICompany_FDAHearing_Final.pdf">MISICompany_FDAHearing_Final</a></p>
<p><strong>Some Highlights from Others</strong></p>
<p>An interesting twist on the concept of having descriptive links was the consortium of speakers who advocated for an FDA link or insignia that would indicate where to click for ISI and would serve as an indication that the source was legitimate.  This idea inspired many questions from the panel and among people in the audience – what would the FDA’s role be in the use and governance of such an insignia or link?  Would it only be regulated products or could anyone start to use that same insignia? </p>
<p>One of the best presentations was from the CEO of <a title="Heartbeat Digital's site" href="http://www.heartbeatdigital.com/" target="_blank">Heartbeat Digital</a>, Bill Drummy, as he walked the FDA panel through a hypothetical health information search online, capturing all of the places where someone interested in information on rheumatoid arthritis might be bounced around through search engines, ads and social media.  He walked them through what the experience might be like, flaws and all, which worked to provide a perspective on where the influence of pharmaceutical companies can benefit the experience, and where their influence needs to be monitored so as not to interfere.    </p>
<p>The majority of presenters did have a focus on patients and caregivers, but a few also focused on the Health Care Professional (HCP).  There was a shared understanding among many of the presenters that HCPs are looking for unbiased clinical information (not promotional language), and want to ask advice of other physicians, as long as there is transparency regarding any affiliations the physicians providing the information might have with pharma companies, and clear presentation of their credentials. The openness of authorship and audience in social media makes the physician’s choice and use of social media a delicate matter.  </p>
<p>Pfizer gave a great presentation to close out the hearing that walked the FDA panel through their journey of discovery regarding how physicians engage in social media and resist promotion in the space, giving examples from their partnership with Sermo. </p>
<p><strong>Final Thoughts</strong></p>
<p>Despite general agreement among various presenters in many areas, there were also competing thoughts that the panel will have to filter through and a lot of hard supporting data that the panel will want to analyze. And even more information will be trickling into the open docket, which will close at the end of February 2010. </p>
<p>Do we think that something will come of these hearings?  Yes.  Will it be slow to come?  Probably— but through no fault of the FDA.  It is a tricky subject!  Most importantly, we think that whatever the FDA panel decides will incorporate some of the consistent themes struck throughout the two days of hearings: pharmaceutical companies needing to clearly identify themselves when participating in social forums, the need for flexibility and clarity when dealing with ISI, and giving heed to the preconceptions that some groups have when dealing with pharmaceutical companies. </p>
<p>As for how this will affect the people using these evolving interactive tools, we anticipate that many patients and caregivers will welcome having the opportunity to hear pharmaceutical companies’ voices as part of the social dialogue. However, physicians may become even more cautious and selective when it comes to engaging in any online dialogue in a forum where pharmaceutical companies are participants.   </p>
<p><a title="FDA Public Hearing site" href="http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm184250.htm" target="_blank">Here is the link to the FDA&#8217;s site on the public hearing</a>. You can acces transcripts, the webcast and submit electronic comments through February 28, 2010</p>
<p>A PDF of our presentation deck is here: <a href="http://www.misicompany.com/xdblog/wp-content/uploads/2009/11/MISICompany_FDAHearing_Final.pdf">MISICompany_FDAHearing_Final</a></p>
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