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	<title>BU Now &#187; Healthy Law Program</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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