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	<title>BU Now &#187; Kevin Outterson</title>
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		<title>FDA and outsourced drug making</title>
		<link>http://blogs.bu.edu/bunow/2010/06/15/fda-and-outsourced-drug-making/</link>
		<comments>http://blogs.bu.edu/bunow/2010/06/15/fda-and-outsourced-drug-making/#comments</comments>
		<pubDate>Tue, 15 Jun 2010 22:15:03 +0000</pubDate>
		<dc:creator>Dick Taffe</dc:creator>
				<category><![CDATA[Professor Voices]]></category>
		<category><![CDATA[Boston University]]></category>
		<category><![CDATA[BU Law School]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Food and Drug Administration]]></category>
		<category><![CDATA[Healthy Law Program]]></category>
		<category><![CDATA[Kevin Outterson]]></category>
		<category><![CDATA[Merck]]></category>
		<category><![CDATA[outsourcing]]></category>
		<category><![CDATA[Pfizer]]></category>
		<category><![CDATA[pharmaceutical manufacturing]]></category>

		<guid isPermaLink="false">http://blogs.bu.edu/bunow/?p=5951</guid>
		<description><![CDATA[The Food and Drug Administration reportedly will propose tougher regulations for pharmaceutical companies that outsource manufacturing of drugs, making them more responsible for the safety and purity of the products made by contractors.  Law Professor Kevin Outterson, an authority on food and drug law and director of the Healthy Law Program, says the changes likely [...]]]></description>
			<content:encoded><![CDATA[<p><img class="alignright size-full wp-image-5952" src="http://blogs.bu.edu/bunow/files/2010/06/pills.bmp" alt="pills" width="69" height="104" />The<a href="http://www.fda.gov/"> Food and Drug</a> Administration <a title="reportedly" href="http://online.wsj.com/article/SB10001424052748704324304575307421660792654.html?KEYWORDS=FDA" target="_blank">reportedly</a> will propose tougher regulations for pharmaceutical companies that outsource manufacturing of drugs, making them more responsible for the safety and purity of the products made by contractors.  <a href="http://www.bu.edu/law/">Law</a> Professor <a title="Kevin Outterson" href="http://www.bu.edu/law/faculty/profiles/bios/full-time/outterson_k.html" target="_blank">Kevin Outterson</a>, an authority on food and drug law and director of the <a href="http://www.bu.edu/law/prospective/jd/concentrations/healthlaw.html">Healthy Law Program</a>, says the changes likely will have little effect because branded drug manufacturers put their reputations on the line every day with their drugs already.</p>
<p><em>&#8220;I&#8217;d be surprised if the FDA requirements are a great improvement over what Pfizer and Merck already do to protect the integrity of their supply chain.”</em></p>
<p>Contact Kevin Outterson, 617-353-3103, <a href="mailto:mko@bu.edu">mko@bu.edu</a></p>
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		<title>Pfizer&#8217;s history of illegal marketing</title>
		<link>http://blogs.bu.edu/bunow/2009/11/09/pfizers-history-of-illegal-marketing/</link>
		<comments>http://blogs.bu.edu/bunow/2009/11/09/pfizers-history-of-illegal-marketing/#comments</comments>
		<pubDate>Mon, 09 Nov 2009 21:29:21 +0000</pubDate>
		<dc:creator>Dick Taffe</dc:creator>
				<category><![CDATA[Professor Voices]]></category>
		<category><![CDATA[Health Law Program]]></category>
		<category><![CDATA[Kevin Outterson]]></category>
		<category><![CDATA[Pfizer]]></category>
		<category><![CDATA[School of Law]]></category>

		<guid isPermaLink="false">http://blogs.bu.edu/bunow/?p=3704</guid>
		<description><![CDATA[Bloomberg News reports on the history of Pfizer, the world&#8217;s largest drug company, illegally promoting drugs for uses not approved by the FDA &#8211; even after being heavily fined for doing so.  Law Professor Kevin Outterson, an expert on drug marketing and director of the BU School of Law&#8217;s Health Law Program, says big pharma can [...]]]></description>
			<content:encoded><![CDATA[<p><img class="alignleft size-thumbnail wp-image-3706" src="http://blogs.bu.edu/bunow/files/2009/11/pills-150x150.jpg" alt="pills" width="150" height="150" />Bloomberg News <a title="reports" href="http://www.bloomberg.com/apps/news?pid=20601109&amp;sid=a4yV1nYxCGoA&amp;pos=10#" target="_blank">reports</a> on the history of Pfizer, the world&#8217;s largest drug company, illegally promoting drugs for uses not approved by the FDA &#8211; even after being heavily fined for doing so.  Law Professor <a title="Kevin Outterson" href="http://www.bu.edu/law/faculty/profiles/bios/full-time/outterson_k.html" target="_blank">Kevin Outterson</a>, an expert on drug marketing and director of the BU School of Law&#8217;s <a title="Health Law Program" href="http://www.bu.edu/law/prospective/jd/concentrations/healthlaw.html" target="_blank">Health Law Program</a>, says big pharma can afford to pay the fines for such transgressions.</p>
<p><em>&#8220;Drug companies are paying these fines so frequently that they begin to look like speeding tickets when you’re earning billions in profits.&#8221;</em></p>
<p><em> </em></p>
<p>Contact Kevin Outterson, 617-353-3103, <a href="mailto:mko@bu.edu">mko@bu.edu</a></p>
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		<title>Glaxo bets on pandemics</title>
		<link>http://blogs.bu.edu/bunow/2009/10/09/glaxo-bets-on-pandemics/</link>
		<comments>http://blogs.bu.edu/bunow/2009/10/09/glaxo-bets-on-pandemics/#comments</comments>
		<pubDate>Fri, 09 Oct 2009 18:57:21 +0000</pubDate>
		<dc:creator>Dick Taffe</dc:creator>
				<category><![CDATA[Uncategorized]]></category>
		<category><![CDATA[Flu pandemic]]></category>
		<category><![CDATA[Glaxo]]></category>
		<category><![CDATA[H1N1 swine flu virus]]></category>
		<category><![CDATA[Kevin Outterson]]></category>

		<guid isPermaLink="false">http://blogs.bu.edu/bunow/?p=3397</guid>
		<description><![CDATA[British pharmaceutical giant GlaxoSmithKline PLC has spent more than $3.2 billion over the past five years on research and acquisitions specifically related to an anticipated flu pandemic.  Now comes the payoff as the swine flu sweeps the world.  Law Professor Kevin Outterson, head of the Health Law Program and an authority on drug marketing, said Glaxo [...]]]></description>
			<content:encoded><![CDATA[<p><img class="alignleft size-full wp-image-3600" src="http://blogs.bu.edu/bunow/files/2009/10/swine.bmp" alt="swine" width="281" height="244" />British pharmaceutical giant GlaxoSmithKline PLC has spent more than $3.2 billion over the past five years on research and acquisitions <a title="specifically related" href="http://online.wsj.com/article/SB125503764592374389.html" target="_blank">specifically related </a>to an anticipated flu pandemic.  Now comes the payoff as the swine flu sweeps the world.  Law Professor <a title="Kevin Outterson" href="http://www.bu.edu/law/faculty/profiles/bios/full-time/outterson_k.html" target="_blank">Kevin Outterson</a>, head of the Health Law Program and an authority on drug marketing, said Glaxo deserves what it now can reap.</p>
<p><em>&#8220;It is very important for governments to reward Glaxo for these efforts. We should stop insisting on bargain prices for valuable vaccines produced to address pandemics.&#8221;</em></p>
<p>Contact Kevin Outterson, 617-353-3103, <a href="mailto:mko@bu.edu">mko@bu.edu</a></p>
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