<?xml version="1.0" encoding="UTF-8"?>
<rss version="2.0"
	xmlns:content="http://purl.org/rss/1.0/modules/content/"
	xmlns:wfw="http://wellformedweb.org/CommentAPI/"
	xmlns:dc="http://purl.org/dc/elements/1.1/"
	xmlns:atom="http://www.w3.org/2005/Atom"
	xmlns:sy="http://purl.org/rss/1.0/modules/syndication/"
	xmlns:slash="http://purl.org/rss/1.0/modules/slash/"
	>

<channel>
	<title>PRforPharma &#187; FDA Hearing</title>
	<atom:link href="http://prforpharma.com/tag/fda-hearing/feed/" rel="self" type="application/rss+xml" />
	<link>http://prforpharma.com</link>
	<description>Discussions about social media, PR and marketing for pharmaceutical companies</description>
	<lastBuildDate>Wed, 27 Apr 2011 16:28:52 +0000</lastBuildDate>
	<language>en</language>
	<sy:updatePeriod>hourly</sy:updatePeriod>
	<sy:updateFrequency>1</sy:updateFrequency>
	<generator>http://wordpress.org/?v=3.3.1</generator>
		<item>
		<title>Why Guidance Will Not be the Most Important Thing to Come Out of the FDA Social Media Hearings</title>
		<link>http://prforpharma.com/2009/11/16/why-guidance-will-not-be-the-most-important-thing-to-come-out-of-the-fda-social-media-hearings/#utm_source=feed&#038;utm_medium=feed&#038;utm_campaign=feed</link>
		<comments>http://prforpharma.com/2009/11/16/why-guidance-will-not-be-the-most-important-thing-to-come-out-of-the-fda-social-media-hearings/#comments</comments>
		<pubDate>Mon, 16 Nov 2009 21:45:45 +0000</pubDate>
		<dc:creator>Chris Iafolla</dc:creator>
				<category><![CDATA[Uncategorized]]></category>
		<category><![CDATA[FDA Hearing]]></category>
		<category><![CDATA[Pharmaceutical marketing]]></category>
		<category><![CDATA[Social media for pharma]]></category>

		<guid isPermaLink="false">http://prforpharma.com/?p=68</guid>
		<description><![CDATA[The FDA public hearings on social media have come and gone.  Every phrase uttered from the podium and every word that appeared in a presentation has been examined ad nauseam (for a list of recaps on the event, take a look at Shwen Gwee’s post).  For two days last week, social media took center stage [...]]]></description>
			<content:encoded><![CDATA[
<div class="topsy_widget_data topsy_theme_blue" style="float: right;margin-left: 0.75em; background: url(data:,%7B%20%22url%22%3A%20%22http%253A%252F%252Fprforpharma.com%252F2009%252F11%252F16%252Fwhy-guidance-will-not-be-the-most-important-thing-to-come-out-of-the-fda-social-media-hearings%252F%22%2C%20%22style%22%3A%20%22big%22%2C%20%22title%22%3A%20%22Why%20Guidance%20Will%20Not%20be%20the%20Most%20Important%20Thing%20to%20Come%20Out%20of%20the%20FDA%20Social%20Media%20Hearings%22%20%7D);"></div>
<p><img class="alignleft" src="http://www.mediabistro.com/fishbowlny/original/bull-horn.jpg" alt="" width="200" height="281" />The FDA public hearings on social media have come and gone.  Every phrase uttered from the podium and every word that appeared in a presentation has been examined ad nauseam (for a list of recaps on the event, take a look at <a href="http://www.med20.com/blog/2009/11/fda_open_forum_on_ineternet_and_social_media/">Shwen Gwee’s post</a>).  For two days last week, social media took center stage in the pharmaceutical marketing mix.  The FDA hearings created a spotlight on social media and forced marketers to at least consider how it fits into their overall strategy—something many were unwilling to do in the past.</p>
<p>But now we enter an abyss.  Social media no longer sits at the top of the agenda of policy makers, pharmaceutical marketers and agency people alike.  A conversation that escalated to a full-blown debate last week could slip into anonymity.</p>
<p>Many people are focusing on the official guidance that will eventually be issued by the FDA on how to use social media in pharmaceutical marketing.  But whatever guidance is forthcoming from the FDA is not the most important deliverable that will come out of the hearings.  While it will help to ease tensions around engaging in social media and hopefully remove some of the regulatory barriers, it still does little to educate an industry that is just now starting to grasp the potential of social media.</p>
<p>The most important part of the FDA social media hearings is already in process—the discussion it sparked.</p>
<p>My belief has always been that regulatory concerns are just one of the many challenges that face pharmaceutical marketers.  It is a barrier but if it were suddenly removed, there would not be a flood of pharma companies jumping into social media.  Why?  Because another major hurdle is changing a culture that is not comfortable with relinquishing brand control and does not fully believe in the value of social media.  Last week was a monumental step forward in that education and advocacy process.</p>
<p>For two days last week, the FDA handed social media pundits a bull horn.  And while the conversation spiked to a deafening level—it is essential that we continue that momentum.  Bloggers, trade press and mainstream media are covering the issues of social media for the pharmaceutical industry in droves. The FDA handed us a stage: will we continue to occupy the center or will we exit stage left?</p>

<p><a class="a2a_dd a2a_target addtoany_share_save" href="http://www.addtoany.com/share_save#url=http%3A%2F%2Fprforpharma.com%2F2009%2F11%2F16%2Fwhy-guidance-will-not-be-the-most-important-thing-to-come-out-of-the-fda-social-media-hearings%2F&amp;title=Why%20Guidance%20Will%20Not%20be%20the%20Most%20Important%20Thing%20to%20Come%20Out%20of%20the%20FDA%20Social%20Media%20Hearings" id="wpa2a_2"><img src="http://prforpharma.com/wp-content/plugins/add-to-any/share_save_171_16.png" width="171" height="16" alt="Share"/></a></p>]]></content:encoded>
			<wfw:commentRss>http://prforpharma.com/2009/11/16/why-guidance-will-not-be-the-most-important-thing-to-come-out-of-the-fda-social-media-hearings/feed/</wfw:commentRss>
		<slash:comments>4</slash:comments>
		</item>
		<item>
		<title>Pharmaceutical Social Media: Focus on the Patient and Return on Health</title>
		<link>http://prforpharma.com/2009/11/13/pharmaceutical-social-media-focus-on-the-patient-and-return-on-health/#utm_source=feed&#038;utm_medium=feed&#038;utm_campaign=feed</link>
		<comments>http://prforpharma.com/2009/11/13/pharmaceutical-social-media-focus-on-the-patient-and-return-on-health/#comments</comments>
		<pubDate>Fri, 13 Nov 2009 15:30:01 +0000</pubDate>
		<dc:creator>Chris Iafolla</dc:creator>
				<category><![CDATA[Uncategorized]]></category>
		<category><![CDATA[FDA Hearing]]></category>
		<category><![CDATA[Return on Health]]></category>

		<guid isPermaLink="false">http://prforpharma.com/?p=63</guid>
		<description><![CDATA[You may have heard; the FDA is holding a public hearing on social media and how it impacts pharmaceutical companies.  There have been a number of excellent presentations so far that have moved this conversation forward and closer to a solution. But one thing has been noticeably absent: the patient. The entire conversation around social [...]]]></description>
			<content:encoded><![CDATA[
<div class="topsy_widget_data topsy_theme_blue" style="float: right;margin-left: 0.75em; background: url(data:,%7B%20%22url%22%3A%20%22http%253A%252F%252Fprforpharma.com%252F2009%252F11%252F13%252Fpharmaceutical-social-media-focus-on-the-patient-and-return-on-health%252F%22%2C%20%22style%22%3A%20%22big%22%2C%20%22title%22%3A%20%22Pharmaceutical%20Social%20Media%3A%20Focus%20on%20the%20Patient%20and%20Return%20on%20Health%22%20%7D);"></div>
<p><img class="alignleft" src="http://www.cheaplifeinsurance.ca/Images/medical-evacuation-insurance.jpg" alt="" width="180" height="302" />You may have heard; the <a href="http://www.clickz.com/3635647">FDA is holding</a> <a href="http://blog.medadnews.com/index.php/2009/11/12/day-1-of-pharma-social-media-hearings-after-the-morning/">a public hearing</a> on <a href="http://pharmamkting.blogspot.com/2009/11/fda-social-media-hearing-day-1-my-key.html">social media</a> and how it impacts <a href="http://www.fdasm.com/">pharmaceutical companies</a>.  There have been a number of excellent presentations so far that have moved this conversation forward and closer to a solution.</p>
<p>But one thing has been noticeably absent: the patient.</p>
<p>The entire conversation around social media in pharma has centered on how it can help the marketer.  It’s been positioned as yet another tool in a marketer’s bag of tricks. The overwhelming concern before engaging in social media tends to be around how to drive product and brand awareness; and ultimately, revenue.  I don’t absolve myself from this dynamic.  I certainly have spent my fair share of time discussing how social media can help improve the marketing of a pharmaceutical company and enhance brand loyalty.  Hey, we are marketers; our job is to generate leads.</p>
<p>But there has been something missing from the conversation to date that should be the central part of every social media effort in the pharmaceutical industry.  Before embarking on a social media journey, every marketer, and every executive should ask one simple question.  I know what you are thinking: every executive wants to know the ROI of social media.  That’s not it.  Some people have started discussing more progressive measures like Return on Reputation (ROR). While that gets closer to the right question it doesn’t get to the heart of <em>why </em>to engage in social media.  The question every marketer should ask is: what’s the <strong>Return on Health (ROH). </strong>If the answer to the question is zero then stop immediately and walk away.  Go no further because your involvement in social media will fail and damage the community in the process.  Ultimately, the patient has to be at the center of every social media program.  If you can’t identify any <strong>Return on Health </strong>you shouldn’t move forward.</p>
<p>This doesn’t mean you throw out other measures like ROI.  I’m a capitalist and like to make money as much as the next guy.  But when we are talking about marketing pharmaceutical products, there has to be a higher purpose.  Starting from “How do we make money?” and working to how it will impact the patient is a quick route to failure.  I promise, if you flip that model and start with the patient—the money will come.</p>
<p>Does this mean that social media efforts can’t focus on building the corporate brand?  Of course not.  If the patient is at the center of these efforts then those efforts are more likely to achieve success, which has been clearly defined.  Take a hypothetical, but common example of a biotech company that is in the midst of an early-stage clinical trial.  It’s no secret that it takes enormous amounts of cash to get a drug from discovery to general availability.  It’s reasonable to assume then that a biotech’s goal at this stage is to raise money.  Without a heaping pile of liquid assets a biotech is doomed.  That’s the harsh reality no matter how good the drug in question might be.  But raising money doesn’t seem to line up nicely with the needs of the patient in this case.</p>
<p>It should.</p>
<p>Suppose that biotech has developed a small molecule drug that shows promise in treating late-stage cancers.  With the patient at the center, this company might seek to engage in social media efforts geared toward educating patients and caregivers on living with late-stage cancer.  It might also seek to energize communities on fund raising for cancer research while clearly outlining the staggering impact cancer has on the world.  This same company might even share some of its research in scientific communities to advance other research efforts in similar areas.  Imagine that.  All of these efforts would have a high <strong>Return on Health </strong>in the long-term if the drug proves to be effective.  In the short term, it would help the company by creating mindshare and goodwill with future patients.  A biotech that has established that type of awareness before it ever brings a drug to market is a company that will undoubtedly raise more money in financing rounds and have a much more attractive liquidation event.  First the patient, then the money.  The point?  You can make money and generate a <strong>Return on Health (ROH), </strong>if and only if, the patient is at the center.</p>
<p>It’s simple really: if the patient is the focus of your social media engagement then your interactions will reflect that.  Conversely, if profit motivation is your driving force then you are likely to be tempted into making poor decisions such as paying people to post Wikiepedia entries or covertly pushing products on a health chat page.  Using <strong>Return on Health </strong>as the primary measure of a social media program establishes a decision-making framework that won’t lead you astray.</p>
<p>The goal of social media should always be to add more value than you extract.  Does measuring ROI tell you if you have accomplished that goal?  If you are truly focused on the patient then you will engage transparently, communicate honestly and seek to educate and not exploit.</p>
<p><strong>What’s the Return on Health (ROH) of your social media efforts? </strong></p>

<p><a class="a2a_dd a2a_target addtoany_share_save" href="http://www.addtoany.com/share_save#url=http%3A%2F%2Fprforpharma.com%2F2009%2F11%2F13%2Fpharmaceutical-social-media-focus-on-the-patient-and-return-on-health%2F&amp;title=Pharmaceutical%20Social%20Media%3A%20Focus%20on%20the%20Patient%20and%20Return%20on%20Health" id="wpa2a_4"><img src="http://prforpharma.com/wp-content/plugins/add-to-any/share_save_171_16.png" width="171" height="16" alt="Share"/></a></p>]]></content:encoded>
			<wfw:commentRss>http://prforpharma.com/2009/11/13/pharmaceutical-social-media-focus-on-the-patient-and-return-on-health/feed/</wfw:commentRss>
		<slash:comments>17</slash:comments>
		</item>
		<item>
		<title>The Implications of an FDA-Approved Symbol for Branded Social Media</title>
		<link>http://prforpharma.com/2009/11/10/the-implications-of-an-fda-approved-symbol-for-branded-social-media/#utm_source=feed&#038;utm_medium=feed&#038;utm_campaign=feed</link>
		<comments>http://prforpharma.com/2009/11/10/the-implications-of-an-fda-approved-symbol-for-branded-social-media/#comments</comments>
		<pubDate>Tue, 10 Nov 2009 16:15:30 +0000</pubDate>
		<dc:creator>Chris Iafolla</dc:creator>
				<category><![CDATA[Uncategorized]]></category>
		<category><![CDATA[FDA Hearing]]></category>

		<guid isPermaLink="false">http://prforpharma.com/?p=59</guid>
		<description><![CDATA[With the long-awaited FDA public hearings on social media in pharmaceutical marketing set to kick off this week, the PhRMA has fired a warning shot.  Yesterday, the PhRMA released a statement suggesting the idea of an “FDA-approved Use of Universal Safety Symbol,” for branded/sponsored health information online. For example, this symbol could be used if [...]]]></description>
			<content:encoded><![CDATA[
<div class="topsy_widget_data topsy_theme_blue" style="float: right;margin-left: 0.75em; background: url(data:,%7B%20%22url%22%3A%20%22http%253A%252F%252Fprforpharma.com%252F2009%252F11%252F10%252Fthe-implications-of-an-fda-approved-symbol-for-branded-social-media%252F%22%2C%20%22style%22%3A%20%22big%22%2C%20%22title%22%3A%20%22The%20Implications%20of%20an%20FDA-Approved%20Symbol%20for%20Branded%20Social%20Media%22%20%7D);"></div>
<p><img class="alignleft" src="http://rlv.zcache.com/fda_approved_magnet-p147725793948621812qjy4_400.jpg" alt="" width="240" height="240" />With the long-awaited FDA public hearings on social media in pharmaceutical marketing set to kick off this week, the PhRMA has fired a warning shot.  Yesterday, the <a href="http://www.phrma.org/news_room/press_releases/phrma_statement_about_accessing_online_health_information/">PhRMA released a statement</a> suggesting the idea of an “FDA-approved Use of Universal Safety Symbol,” for branded/sponsored health information online.</p>
<p>For example, this symbol could be used if a pharma company was linking to branded content via a Tweet or through a paid search ad.  <a href="http://www.pharmalot.com/2009/11/a-universal-safety-symbol-for-drug-web-sites/">The intent is to distinguish legitimate, authorized content</a> online from the content that is not sanctioned by the FDA.  This symbol would be used in much the same way as the safe-harbor for DTC advertising on television—as long as it points to a regulated site with all of the risk information presented than it would be in bounds.</p>
<p>Even as I write this post, I am not sure where I come down on the usefulness of this kind of symbol.  On the one hand, the intent is clearly in the right place.  By offering a solution (where few people have) the PhRMA is acknowledging that it recognizes the value in social media tools.  The PhRMA is attempting to present a solution that eases the trepidation most pharmaceutical marketers currently feel when approaching any type of online marketing effort.  Clearly, patients are congregating online and there needs to be a plan in place that allows pharmaceutical companies the ability, and freedom, to reach those patients.</p>
<p>On the flip side, an FDA-approved symbol seems to send the wrong message to pharmaceutical marketers about the way they should be communicating online.  In going this route, the FDA would essentially be treating social media tools just as they have handled TV and radio ads in the past.  In the case of social media, we are dealing with a very different platform with a new set of rules that govern the community.  Applying old methods of regulating the industry to this community could fall on its face.  When we discuss social media strategies with our clients, we always implore them to stay away from blatant product promotion.  Because social media is about adding as much value as you extract, it does not lend itself to overt product promotion.  The FDA-approved symbol may help with advertising models, but it doesn’t really address social media because it circumvents the community dynamic.  With this symbol, pharmaceutical marketers might be tempted to simply push branded content out through social media channels.  That’s not community engagement, that’s advertising.</p>
<p>Ultimately, if pharmaceutical marketers are to get engaged with social media it should not be as a means to only push advertising and branded Websites.  So while this proposal by the PhRMA does get the conversation started, I am not sure it sends the right message on proper community engagement.</p>

<p><a class="a2a_dd a2a_target addtoany_share_save" href="http://www.addtoany.com/share_save#url=http%3A%2F%2Fprforpharma.com%2F2009%2F11%2F10%2Fthe-implications-of-an-fda-approved-symbol-for-branded-social-media%2F&amp;title=The%20Implications%20of%20an%20FDA-Approved%20Symbol%20for%20Branded%20Social%20Media" id="wpa2a_6"><img src="http://prforpharma.com/wp-content/plugins/add-to-any/share_save_171_16.png" width="171" height="16" alt="Share"/></a></p>]]></content:encoded>
			<wfw:commentRss>http://prforpharma.com/2009/11/10/the-implications-of-an-fda-approved-symbol-for-branded-social-media/feed/</wfw:commentRss>
		<slash:comments>2</slash:comments>
		</item>
	</channel>
</rss>

