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		<title>Feds Chase Down Faulty Skincare Promos</title>
		<link>http://blog.pharmexec.com/2009/08/26/feds-chase-down-faulty-skincare-promos/</link>
		<comments>http://blog.pharmexec.com/2009/08/26/feds-chase-down-faulty-skincare-promos/#comments</comments>
		<pubDate>Wed, 26 Aug 2009 21:13:46 +0000</pubDate>
		<dc:creator>George Koroneos</dc:creator>
				<category><![CDATA[FDA]]></category>
		<category><![CDATA[Marketing]]></category>
		<category><![CDATA[Advertising]]></category>
		<category><![CDATA[Allergan]]></category>
		<category><![CDATA[Clinical trial]]></category>
		<category><![CDATA[Johnson & Johnson]]></category>
		<category><![CDATA[U.S. Food and Drug Administration]]></category>

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		<description><![CDATA[FDA&#8217;s Division of Drug Marketing Communications, this week, posted a slew of warning and untitled letters to pharma firms for misleading skincare advertisements. Johnson &#38; Johnson, Galderma, and Allergan each received a letter documenting complaints ranging from false advertising to unsubstantial efficacy claims.
J&#38;J received a violation letter in response to a journal ad for its [...]]]></description>
			<content:encoded><![CDATA[<p><a href="http://blog.pharmexec.com/wp-content/uploads/2009/08/picture-5.png"><img class="alignright size-full wp-image-1039" title="picture-5" src="http://blog.pharmexec.com/wp-content/uploads/2009/08/picture-5.png" alt="" width="243" height="204" /></a>FDA&#8217;s Division of Drug Marketing Communications, this week, posted a slew of warning and untitled letters to pharma firms for misleading skincare advertisements. Johnson &amp; Johnson, Galderma, and Allergan each received a letter documenting complaints ranging from false advertising to unsubstantial efficacy claims.</p>
<p>J&amp;J received a violation letter in response to a journal ad for its topical anti-inflammatory cream Ertaczo, emblazoned with the words &#8220;Crush. Kill. Destroy,&#8221; in large, orange letters. FDA states that the company is way off-base in touting total annihilation of athlete&#8217;s foot, rather that a decrease and potential for cure.</p>
<p>&#8220;Although [trial] results show modest effectiveness, they clearly do not support the claims that Ertaczo &#8216;wipes out&#8217; or crushes, kills, and destroys tinea infections,&#8221; DDMAC wrote in the letter.</p>
<p>FDA also took issue with the suggested claims that Erataczo is approved for all patients. In fact, the drug is not approved for patients less than 12 years old. <span id="more-1034"></span></p>
<p>Allergen got an even harsher letter, stating that its journal advertisement for the acne gel Aczone is a complete misrepresentation of the results of a clinical study, and that the ad &#8220;grossly overstates the efficacy of the drug by presenting only the most favorable result for Aczone.&#8221;</p>
<p>The ad stated that patients could see a reduction in acne by as much as 24 percent in two weeks. The study FDA is referring to showed that at two weeks, patients showed only a 2 percent decrease in inflammatory lesions.</p>
<p>Finally, Galderma received a warning letter regarding professional visual aids for its skin discoloration cream Tri-Luma. According to DDMAC, the ads &#8220;suggest uses for Tri-Luma that have not been approved by FDA, and thus create new  &#8216;intended uses&#8217; for the drug for which the product lacks adequate directions, broaden indication for Tri-Luma, and omit and minimize important risk information for the drug.&#8221;</p>
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