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	<title>Pharma 101 - Pharmaceutical Fraud &#187; Medicare Fraud</title>
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	<link>http://pharmaceutical-kickbacks.com</link>
	<description>Information &#38; Insight On Qui Tam Lawsuits Based Upon Unlawful Kickbacks, Marketing &#38; Pricing Conduct.</description>
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		<title>GI Drug Overhyped, Warns FDA</title>
		<link>http://pharmaceutical-kickbacks.com/gi-drug-overhyped-warns-fda/</link>
		<comments>http://pharmaceutical-kickbacks.com/gi-drug-overhyped-warns-fda/#comments</comments>
		<pubDate>Mon, 10 May 2010 19:10:41 +0000</pubDate>
		<dc:creator>Nolan and Auerbach</dc:creator>
				<category><![CDATA[Pharmaceutical]]></category>
		<category><![CDATA[Medicare Fraud]]></category>
		<category><![CDATA[off label]]></category>
		<category><![CDATA[off label drug marketing]]></category>
		<category><![CDATA[Pharmaceutical Fraud]]></category>

		<guid isPermaLink="false">http://pharmaceutical-kickbacks.com/?p=228</guid>
		<description><![CDATA[On May 5th, the FDA posted a letter sent to Shire Development, Inc. regarding the marketing of LIALDA, an oral sustained release multimatrix formulation of mesalazine approved in 2007. LIALDA is indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. The Warning Letter stated that a brochure used by [...]]]></description>
			<content:encoded><![CDATA[<p>On May 5th, the FDA posted a letter sent to Shire Development, Inc. regarding the marketing of LIALDA, an oral sustained release multimatrix formulation of mesalazine approved in 2007. LIALDA is indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. The <a href="http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM210902.pdf" onclick="pageTracker._trackPageview('/outgoing/www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM210902.pdf?referer=');">Warning Letter</a> stated that a brochure used by Shire to market LIALDA is false or misleading because it overstates the efficacy of LIALDA, contains unsubstantiated superiority claims, omits risk information associated with the drug, broadens the indication of the drug, and contains unsubstantiated claims. LIALDA has been used <a href="http://www.whistleblowerfirm.com/pharmaceutical-fraud/off-label-marketing/" onclick="pageTracker._trackPageview('/outgoing/www.whistleblowerfirm.com/pharmaceutical-fraud/off-label-marketing/?referer=');">off–label</a> for other lower GI tract conditions, such as Crohn&#8217;s disease, general bowel infection and abdominal pain.</p>
<p>For more information about <a href="http://www.whistleblowerfirm.com/about-the-law/qui-tam/" onclick="pageTracker._trackPageview('/outgoing/www.whistleblowerfirm.com/about-the-law/qui-tam/?referer=');">qui tam</a> law and <a href="http://www.whistleblowerfirm.com/pharmaceutical-fraud/overview/" onclick="pageTracker._trackPageview('/outgoing/www.whistleblowerfirm.com/pharmaceutical-fraud/overview/?referer=');">pharmaceutical fraud</a>, contact <a href="http://www.whistleblowerfirm.com/" onclick="pageTracker._trackPageview('/outgoing/www.whistleblowerfirm.com/?referer=');">Nolan and Auerbach, PA</a>.</p>
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		<title>Wyeth under Fire for Alleged Medicaid Fraud</title>
		<link>http://pharmaceutical-kickbacks.com/wyeth-under-fire-for-alleged-medicaid-fraud/</link>
		<comments>http://pharmaceutical-kickbacks.com/wyeth-under-fire-for-alleged-medicaid-fraud/#comments</comments>
		<pubDate>Thu, 21 May 2009 17:48:53 +0000</pubDate>
		<dc:creator>Nolan and Auerbach</dc:creator>
				<category><![CDATA[Medicare]]></category>
		<category><![CDATA[Medicare Fraud]]></category>
		<category><![CDATA[Pharmaceutical]]></category>
		<category><![CDATA[Health care]]></category>
		<category><![CDATA[Medicaid]]></category>
		<category><![CDATA[Medicaid Drug Rebate Program]]></category>
		<category><![CDATA[Pharmaceutical Fraud]]></category>
		<category><![CDATA[Pharmaceutical industry]]></category>
		<category><![CDATA[Pharmaceutical Kickbacks]]></category>
		<category><![CDATA[Wyeth]]></category>

		<guid isPermaLink="false">http://pharmaceutical-kickbacks.com/?p=143</guid>
		<description><![CDATA[The U.S. government and 16 states have joined in two whistleblower suits against pharmaceutical giant Wyeth. The drug company allegedly failed to pay hundreds of millions in rebates to the Medicaid program, according to a May 18, 2009 release by the U.S. Department of Justice. The suit alleges that Wyeth knowingly failed to give the [...]]]></description>
			<content:encoded><![CDATA[<p>The U.S. government and 16 states have joined in two whistleblower suits against pharmaceutical giant Wyeth. The drug company allegedly failed to pay hundreds of millions in rebates to the Medicaid program, according to a May 18, 2009 release by the U.S. Department of Justice.</p>
<p>The suit alleges that Wyeth knowingly failed to give the government the same discounts it provided to private purchasers, as required by Medicaid law. According to the release, between 2000 and 2006, Wyeth offered steep discounts to thousands of hospitals nationwide for the drugs Protonix Oral and Protonix IV, two proton pump inhibitors used to suppress stomach acid. This pricing arrangement required that the hospitals purchase both drugs together, under a so-called &#8220;bundled&#8221; arrangement and it offered them a steep discount for doing so. Wyeth did this in part to gain access to the far more lucrative retail outpatient market, intending that patients who used the intravenous version of Protonix in the hospital would later purchase Protonix Oral once discharged. Under the bundled arrangement, hospitals that placed both products on their formularies and attained certain market share requirements were entitled to up to a 94% discount off the list price of Protonix Oral and up to 80% off the list price of Protonix IV. Although Wyeth was required under the Medicaid Drug Rebate Program to determine the effective prices paid by hospitals under this arrangement and to pass along the benefit of the lowest prices to the state Medicaid programs, Wyeth allegedly failed to do so.</p>
<p>For more on this case, go to <a href="http://www.usdoj.gov/opa/pr/2009/May/09-civ-483.html." onclick="pageTracker._trackPageview('/outgoing/www.usdoj.gov/opa/pr/2009/May/09-civ-483.html.?referer=');">US DOJ website</a><a href="http://www.usdoj.gov/opa/pr/2009/May/09-civ-483.html" onclick="pageTracker._trackPageview('/outgoing/www.usdoj.gov/opa/pr/2009/May/09-civ-483.html?referer=');"> </a></p>
<p>For more information about Qui Tam law,  <a href="http://whistleblowerfirm.com" onclick="pageTracker._trackPageview('/outgoing/whistleblowerfirm.com?referer=');">Medicare Fraud</a> and <a href="http://whistleblowerfirm.com" onclick="pageTracker._trackPageview('/outgoing/whistleblowerfirm.com?referer=');">Health Care Fraud</a> , contact <a href="http://www.whistleblowerfirm.com/" onclick="pageTracker._trackPageview('/outgoing/www.whistleblowerfirm.com/?referer=');">Nolan and Auerbach, PA. </a></p>
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		<title>STOP Act Charged with Curbing Medicare Fraud</title>
		<link>http://pharmaceutical-kickbacks.com/stop-act-charged-with-curbing-medicare-fraud/</link>
		<comments>http://pharmaceutical-kickbacks.com/stop-act-charged-with-curbing-medicare-fraud/#comments</comments>
		<pubDate>Thu, 21 May 2009 17:38:05 +0000</pubDate>
		<dc:creator>Nolan and Auerbach</dc:creator>
				<category><![CDATA[Medicare]]></category>
		<category><![CDATA[Pharmaceutical]]></category>
		<category><![CDATA[Health care]]></category>
		<category><![CDATA[Medicare Fraud]]></category>
		<category><![CDATA[Pharmaceutical Fraud]]></category>
		<category><![CDATA[United States Department of Health and Human Services]]></category>

		<guid isPermaLink="false">http://pharmaceutical-kickbacks.com/?p=140</guid>
		<description><![CDATA[National organizations, including AARP, are endorsing the bipartisan &#8220;Seniors and Taxpayers Obligation Protection (STOP) Act,&#8221; which is awaiting senate vote. Sponsored by Senators Mel Martinez (R-FL), Bill Nelson (D-FL) and John Cornyn (R-TX), this legislation is aimed at curbing the billions of dollars spent on Medicare fraud each year. Senators backing the bill say it [...]]]></description>
			<content:encoded><![CDATA[<p>National organizations, including AARP, are endorsing the bipartisan &#8220;Seniors and Taxpayers Obligation Protection (STOP) Act,&#8221; which is awaiting senate vote. Sponsored by Senators Mel Martinez (R-FL), Bill Nelson (D-FL) and John Cornyn (R-TX), this legislation is aimed at curbing the billions of dollars spent on Medicare fraud each year.</p>
<p>Senators backing the bill say it would help to improve Health and Human Services&#8217;s (HHS&#8217;s) detection methods and place billing statements under increased scrutiny.</p>
<p>If it becomes law, HHS would identify the 50 counties most vulnerable to fraud and take a watch dog approach to carefully monitoring these designated &#8220;high-risk&#8221; fraud areas.</p>
<p>Among the many things it would do, the legislation would require that HHS establish a tracking system for certain durable medical equipment, and change the current system of using social security numbers as the Medicare Beneficiary Identifier used on Medicare cards.</p>
<p>To learn more about the bill, go to <a href="http://www.govtrack.us/congress/bill.xpd?bill=s110-3164&amp;tab=summary" onclick="pageTracker._trackPageview('/outgoing/www.govtrack.us/congress/bill.xpd?bill=s110-3164_amp_tab=summary&amp;referer=');">http://www.govtrack.us/congress/bill.xpd?bill=s110-3164&amp;tab=summary</a> or <a href="http://www.opencongress.org/bill/110-s3164/show" onclick="pageTracker._trackPageview('/outgoing/www.opencongress.org/bill/110-s3164/show?referer=');">http://www.opencongress.org/bill/110-s3164/show</a>.</p>
<p>For more information about <a href="http://whistleblowerfirm.com" onclick="pageTracker._trackPageview('/outgoing/whistleblowerfirm.com?referer=');">qui tam law </a>and <a href="http://whistleblowerfirm.com" onclick="pageTracker._trackPageview('/outgoing/whistleblowerfirm.com?referer=');">health care fraud</a>, contact <a href="http://whistleblowerfirm.com" onclick="pageTracker._trackPageview('/outgoing/whistleblowerfirm.com?referer=');">Nolan and Auerbach, PA.</a> .</p>
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		<title>Allegations of Pharmaceutical Fraud Lands Forest Labs in Hot Water</title>
		<link>http://pharmaceutical-kickbacks.com/allegations-of-pharmaceutical-fraud-lands-forest-labs-in-hot-water/</link>
		<comments>http://pharmaceutical-kickbacks.com/allegations-of-pharmaceutical-fraud-lands-forest-labs-in-hot-water/#comments</comments>
		<pubDate>Tue, 03 Mar 2009 16:16:20 +0000</pubDate>
		<dc:creator>Nolan and Auerbach</dc:creator>
				<category><![CDATA[Legal]]></category>
		<category><![CDATA[Pharmaceutical]]></category>
		<category><![CDATA[Clinical trial]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Medicare Fraud]]></category>
		<category><![CDATA[Pharmaceutical Fraud]]></category>
		<category><![CDATA[Pharmaceutical Kickbacks]]></category>
		<category><![CDATA[Whistleblower Lawsuit]]></category>

		<guid isPermaLink="false">http://pharmaceutical-kickbacks.com/?p=3</guid>
		<description><![CDATA[The Department of Justice has filed a civil complaint against Forest Laboratories alleging that the pharmaceutical company intentionally concealed a clinical study containing negative results involving the drugs Celexa and Lexapro.  According to the complaint, several top executives at the company did not disclose the results of the study that showed that the drugs were [...]]]></description>
			<content:encoded><![CDATA[<p><span style="font-size: 10pt;"> </span></p>
<p><span style="font-size: 10pt;">The Department of Justice has filed a civil complaint against Forest Laboratories alleging that the pharmaceutical company intentionally concealed a clinical study containing negative results involving the drugs Celexa and Lexapro.  According to the complaint, several top executives at the company did not disclose the results of the study that showed that the drugs were not effective and could even pose risks to children.  In spite of this information, from 2001-2004 the company promoted clinical trials showing the effectiveness of the drugs while concealing the existence of the negative study to anyone including its own medical advisors or sales reps.  Further, the complaint alleges that Forest Laboratories paid <a href="http://www.whistleblowerfirm.com/pharmaceutical-fraud/" onclick="pageTracker._trackPageview('/outgoing/www.whistleblowerfirm.com/pharmaceutical-fraud/?referer=');"><span style="color: blue;">pharmaceutical kickbacks</span></a> including paying for vacations and other benefits to physicians to promote the drugs’ use by physicians.</span></p>
<p><span style="font-size: 10pt;"> </span></p>
<p><span style="font-size: 10pt;">Celexa and Lexapro are popular antidepressants approved by the FDA only for adults.  They are two versions of the same drug, Citalopram. Lexapro is Forest Labs’ blockbuster drug with sales of $2.8 billion in 2008.The company however actively improperly marketed these drugs for children even though in 2008 they sought approval from the FDA to use the drug to treat depression in adolescents.  While antidepressants approved for adults are used by physicians to treat children, Celexa and Lexapro now carry a prominent “black box” warning that these drugs could cause suicidal thinking or behavior in some children.</span></p>
<p><span style="font-size: 10pt;"> </span></p>
<p><span style="font-size: 10pt;">It appears that the Government has joined a <a href="http://whistleblowerfirm.com" onclick="pageTracker._trackPageview('/outgoing/whistleblowerfirm.com?referer=');"><span style="color: blue;">whistleblower lawsuit</span></a> filed by two former Forest Labs employees.  This follows what has clearly been a long-running federal investigation triggered by the filing of a <a href="http://whistleblowerfirm.com" onclick="pageTracker._trackPageview('/outgoing/whistleblowerfirm.com?referer=');"><span style="color: blue;">qui tam </span></a>lawsuit.</span></p>
<p><span style="font-size: 10pt;"> </span></p>
<p>To read more click on <span style="font-size: 10pt; color: black;"><a title="blocked::http://www.nytimes.com/2009/02/26/business/26drug.html?emc=eta1" href="http://www.nytimes.com/2009/02/26/business/26drug.html?emc=eta1" target="_blank" onclick="pageTracker._trackPageview('/outgoing/www.nytimes.com/2009/02/26/business/26drug.html?emc=eta1&amp;referer=');">http://www.nytimes.com/2009/02/26/business/26drug.html?emc=eta1</a> </span></p>
<p>or if you think that you have a Medicare Fraud case click on <a title="blocked::http://www.whistleblowerfirm.com/medicare-fraud/" href="http://www.whistleblowerfirm.com/medicare-fraud/" target="_blank" onclick="pageTracker._trackPageview('/outgoing/www.whistleblowerfirm.com/medicare-fraud/?referer=');">http://www.whistleblowerfirm.com/medicare-fraud/</a></p>
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		<title>Clinical investigator indicted for fraud in pharmaceutical trials of blockbuster drug</title>
		<link>http://pharmaceutical-kickbacks.com/clinical-investigator-indicted-for-fraud-in-pharmaceutical-trials-of-blockbuster-drug/</link>
		<comments>http://pharmaceutical-kickbacks.com/clinical-investigator-indicted-for-fraud-in-pharmaceutical-trials-of-blockbuster-drug/#comments</comments>
		<pubDate>Fri, 15 Jun 2007 14:51:06 +0000</pubDate>
		<dc:creator>Nolan and Auerbach</dc:creator>
				<category><![CDATA[Legal]]></category>
		<category><![CDATA[Pharmaceutical]]></category>
		<category><![CDATA[Clinical trial]]></category>
		<category><![CDATA[Clinical Trial Fraud]]></category>
		<category><![CDATA[Drug Safety]]></category>
		<category><![CDATA[fraud]]></category>
		<category><![CDATA[GlaxoSmithKline]]></category>
		<category><![CDATA[Health care]]></category>
		<category><![CDATA[Medicare]]></category>
		<category><![CDATA[Medicare Fraud]]></category>
		<category><![CDATA[Partial Hospitalization Program]]></category>
		<category><![CDATA[U.S. Food and Drug Administration]]></category>

		<guid isPermaLink="false">http://pharmaceutical-kickbacks.com/?p=37</guid>
		<description><![CDATA[NEW ORLEANS — Dr. Maria Carmen Palazzo was indicted by a federal grand jury on 55 counts of health care fraud and false documentation in connection with a clinical trial of Paxil in children and adolescents, U.S. Attorney Jim Letten said on Thursday. One area of charges involves clinical trial fraud. According to the indictment, [...]]]></description>
			<content:encoded><![CDATA[<p>NEW ORLEANS — Dr. Maria Carmen Palazzo was indicted by a federal grand jury on 55 counts of health care fraud and false documentation in connection with a clinical trial of Paxil in children and adolescents, U.S. Attorney Jim Letten said on Thursday.</p>
<p>One area of charges involves clinical trial fraud. According to the indictment, Palazzo, as a clinical investigator for SmithKline Beecham doing business as GlaxoSmithKline, fraudulently failed to maintain and prepare records required by the FDA for evaluation the drug’s safety and effectiveness in children and adolescents.</p>
<p>During approximately a five-year period, Palazzo also defrauded Medicare in connection with services she claimed to have rendered to patients in a Psychiatric Partial Hospitalization Program at Touro Infirmary , according to the indictment.</p>
<p>The indictment also charges that Palazzo defrauded Medicare by submitting fraudulent invoices to Touro for consulting and medical director services. The indictment says because of that Medicare paid Palazzo over $653,000 she was not entitled to receive. (Consulting and Medical director costs of hospitals are passed on to Medicare in part, under the cost report system).</p>
<p>See the full story <a href="http://www.katc.com/Global/story.asp?S=6660700" target="_blank" onclick="pageTracker._trackPageview('/outgoing/www.katc.com/Global/story.asp?S=6660700&amp;referer=');">here.</a></p>
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		<item>
		<title>Congress now has the power to shake up the FDA</title>
		<link>http://pharmaceutical-kickbacks.com/congress-now-has-the-power-to-shake-up-the-fda/</link>
		<comments>http://pharmaceutical-kickbacks.com/congress-now-has-the-power-to-shake-up-the-fda/#comments</comments>
		<pubDate>Fri, 26 Jan 2007 17:28:57 +0000</pubDate>
		<dc:creator>Nolan and Auerbach</dc:creator>
				<category><![CDATA[Legal]]></category>
		<category><![CDATA[Medicare]]></category>
		<category><![CDATA[Congress]]></category>
		<category><![CDATA[False Claims Act]]></category>
		<category><![CDATA[Medicare Fraud]]></category>
		<category><![CDATA[Pharmaceutical Fraud]]></category>
		<category><![CDATA[Pharmaceutical industry]]></category>
		<category><![CDATA[U.S. Food and Drug Administration]]></category>
		<category><![CDATA[United States]]></category>

		<guid isPermaLink="false">http://pharmaceutical-kickbacks.com/?p=92</guid>
		<description><![CDATA[With the new Democratic-controlled Congress, how the FDA accomplishes enforcement will likely change, which may in turn effect the level of resources devoted to the investigation of qui tam complaint allegations. In June 2006, a government report was issued entitled “Prescription for Harm: The Decline in FDA Enforcement Activity”, as a result of the House [...]]]></description>
			<content:encoded><![CDATA[<p>With the new Democratic-controlled Congress, how the FDA accomplishes enforcement will likely change, which may in turn effect the level of resources devoted to the investigation of qui tam complaint allegations. In June 2006, a government report was issued entitled “Prescription for Harm: The Decline in FDA Enforcement Activity”, as a result of the House Committee on Government Reform having commissioned an investigation to evaluate the FDA enforcement activities related to the pharmaceutical industry under the Bush administration. The Report did not present a well-oiled enforcement machine.</p>
<p>To see the full report, <a href="http://oversight.house.gov/story.asp?ID=1074" target="_blank" onclick="pageTracker._trackPageview('/outgoing/oversight.house.gov/story.asp?ID=1074&amp;referer=');">click here.<br />
</a><br />
To read more about Pharmaceutical Fraud,<a href="http://www.whistleblowerfirm.com/pharmaceutical-fraud/" target="_blank" onclick="pageTracker._trackPageview('/outgoing/www.whistleblowerfirm.com/pharmaceutical-fraud/?referer=');"> click here.</a></p>
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