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Novartis: Difference between revisions
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In September 2008, the US [[Food and Drug Administration]] (FDA) sent a notice to Novartis Pharmaceuticals regarding its advertising of [[Focalin]] XR, an [[ADHD]] drug, in which the company overstated its efficacy while marketing to the public and medical professionals.<ref>{{Cite web |date=2008-09-25 |title=Focalin XR (dexmethylphenidate hydrochloride) extended-release capsules CII |url=https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048118.htm |url-status=live |archive-url=https://web.archive.org/web/20120210144438/https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048118.htm |archive-date=10 February 2012 |access-date=2009-08-05 |website=Warning Letters |publisher=[[Food and Drug Administration|US Food and Drug Administration]] |df=dmy}}</ref> | In September 2008, the US [[Food and Drug Administration]] (FDA) sent a notice to Novartis Pharmaceuticals regarding its advertising of [[Focalin]] XR, an [[ADHD]] drug, in which the company overstated its efficacy while marketing to the public and medical professionals.<ref>{{Cite web |date=2008-09-25 |title=Focalin XR (dexmethylphenidate hydrochloride) extended-release capsules CII |url=https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048118.htm |url-status=live |archive-url=https://web.archive.org/web/20120210144438/https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048118.htm |archive-date=10 February 2012 |access-date=2009-08-05 |website=Warning Letters |publisher=[[Food and Drug Administration|US Food and Drug Administration]] |df=dmy}}</ref> | ||
In 2005, federal prosecutors opened an investigation into Novartis' marketing of several drugs: [[Trileptal]], an antiseizure drug; three drugs for heart conditions—[[Diovan]] (the company's top-selling product), [[Exforge]], and [[Tekturna]]; [[Sandostatin]], a drug to treat a growth hormone disorder; and [[Zelnorm]], a drug for irritable bowel syndrome.<ref name=NYTtrileptal/> In September 2010, Novartis agreed to pay US$422.5 million in criminal and civil claims and to enter into a [[corporate integrity agreement]] with the US Office of the Inspector General.<ref>{{Cite web |date=2010-09-30 |title=Novartis Pharmaceuticals Corporation, a US subsidiary of Novartis AG, reaches settlement agreement with US Attorney's Office |url=http://www.novartis.com/newsroom/media-releases/en/2010/1448151.shtml |url-status=dead |archive-url=https://web.archive.org/web/20131017111251/http://www.novartis.com/newsroom/media-releases/en/2010/1448151.shtml |archive-date=17 October 2013 |access-date=2012-01-16 |publisher=Novartis |at=Media Releases |type=press release |df=dmy-all}}</ref> According to ''The New York Times'', "Federal prosecutors accused Novartis of paying illegal kickbacks to health care professionals through speaker programs, advisory boards, entertainment, travel and meals. But aside from pleading guilty to one misdemeanor charge of mislabeling in an agreement that Novartis announced in February, the company denied wrongdoing."<ref name="NYTtrileptal">{{Cite news |last=Wilson |first=Duff |date=2010-09-30 |title=Novartis Settles Off-Label Marketing Case |work= | In 2005, federal prosecutors opened an investigation into Novartis' marketing of several drugs: [[Trileptal]], an antiseizure drug; three drugs for heart conditions—[[Diovan]] (the company's top-selling product), [[Exforge]], and [[Tekturna]]; [[Sandostatin]], a drug to treat a growth hormone disorder; and [[Zelnorm]], a drug for irritable bowel syndrome.<ref name=NYTtrileptal/> In September 2010, Novartis agreed to pay US$422.5 million in criminal and civil claims and to enter into a [[corporate integrity agreement]] with the US Office of the Inspector General.<ref>{{Cite web |date=2010-09-30 |title=Novartis Pharmaceuticals Corporation, a US subsidiary of Novartis AG, reaches settlement agreement with US Attorney's Office |url=http://www.novartis.com/newsroom/media-releases/en/2010/1448151.shtml |url-status=dead |archive-url=https://web.archive.org/web/20131017111251/http://www.novartis.com/newsroom/media-releases/en/2010/1448151.shtml |archive-date=17 October 2013 |access-date=2012-01-16 |publisher=Novartis |at=Media Releases |type=press release |df=dmy-all}}</ref> According to ''The New York Times'', "Federal prosecutors accused Novartis of paying illegal kickbacks to health care professionals through speaker programs, advisory boards, entertainment, travel and meals. But aside from pleading guilty to one misdemeanor charge of mislabeling in an agreement that Novartis announced in February, the company denied wrongdoing."<ref name="NYTtrileptal">{{Cite news |last=Wilson |first=Duff |date=2010-09-30 |title=Novartis Settles Off-Label Marketing Case |work=The New York Times |url=https://www.nytimes.com/2010/10/01/health/policy/01novartis.html |access-date=2012-01-16 |archive-date=16 November 2018 |archive-url=https://web.archive.org/web/20181116215913/https://www.nytimes.com/2010/10/01/health/policy/01novartis.html |url-status=live }}</ref> In the same New York Times article, Frank Lichtenberg, a Columbia professor who receives pharmaceutical financing for research on innovation in the industry, said off-label prescribing was encouraged by the American Medical Association and paid for by insurers, but [[off-label use|off-label marketing]] was clearly illegal. "So it's not surprising that they would settle because they don't have a legal leg to stand on." | ||
In April 2013, federal prosecutors filed two lawsuits against Novartis under the [[False Claims Act]] for off-label marketing and kickbacks; in both suits, prosecutors are seeking [[treble damages]].<ref name="NYTapril2013">{{Cite news |date=2013-04-26 |title=U.S. Sues Novartis Again, Accusing It of Kickbacks |work=The New York Times |url=https://www.nytimes.com/2013/04/27/business/us-files-2nd-suit-accusing-novartis-of-kickbacks-to-doctors.html?_r=0 |access-date=2013-04-27 |archive-date=5 October 2019 |archive-url=https://web.archive.org/web/20191005140435/https://www.nytimes.com/2013/04/27/business/us-files-2nd-suit-accusing-novartis-of-kickbacks-to-doctors.html?_r=0 |url-status=live }}</ref><ref name="DOJ2013">{{Cite web |date=2013-04-26 |title=United States Files Complaint Against Novartis Pharmaceuticals Corp. for Allegedly Paying Kickbacks to Doctors in Exchange for Prescribing Its Drugs |url=https://www.justice.gov/opa/pr/2013/April/13-civ-481.html |url-status=live |archive-url=https://web.archive.org/web/20140413062711/http://www.justice.gov/opa/pr/2013/April/13-civ-481.html |archive-date=2014-04-13 |access-date=2013-04-26 |publisher=The United States Department of Justice}}</ref> The first suit "accused Novartis of inducing pharmacies to switch thousands of kidney transplant patients to its immunosuppressant drug Myfortic in exchange for kickbacks disguised as rebates and discounts".<ref name=NYTapril2013/> In the second, the Justice Department joined a ''[[qui tam]]'', or whistleblower, lawsuit brought by a former sales rep over off-label marketing of three drugs: [[Lotrel]] and [[Valturna]] (both [[hypertension]] drugs), and the diabetes drug, [[Starlix]].<ref name=DOJ2013/> Twenty-seven states, the District of Columbia and Chicago and New York also joined.<ref name=NYTapril2013/> | In April 2013, federal prosecutors filed two lawsuits against Novartis under the [[False Claims Act]] for off-label marketing and kickbacks; in both suits, prosecutors are seeking [[treble damages]].<ref name="NYTapril2013">{{Cite news |date=2013-04-26 |title=U.S. Sues Novartis Again, Accusing It of Kickbacks |work=The New York Times |url=https://www.nytimes.com/2013/04/27/business/us-files-2nd-suit-accusing-novartis-of-kickbacks-to-doctors.html?_r=0 |access-date=2013-04-27 |archive-date=5 October 2019 |archive-url=https://web.archive.org/web/20191005140435/https://www.nytimes.com/2013/04/27/business/us-files-2nd-suit-accusing-novartis-of-kickbacks-to-doctors.html?_r=0 |url-status=live }}</ref><ref name="DOJ2013">{{Cite web |date=2013-04-26 |title=United States Files Complaint Against Novartis Pharmaceuticals Corp. for Allegedly Paying Kickbacks to Doctors in Exchange for Prescribing Its Drugs |url=https://www.justice.gov/opa/pr/2013/April/13-civ-481.html |url-status=live |archive-url=https://web.archive.org/web/20140413062711/http://www.justice.gov/opa/pr/2013/April/13-civ-481.html |archive-date=2014-04-13 |access-date=2013-04-26 |publisher=The United States Department of Justice}}</ref> The first suit "accused Novartis of inducing pharmacies to switch thousands of kidney transplant patients to its immunosuppressant drug Myfortic in exchange for kickbacks disguised as rebates and discounts".<ref name=NYTapril2013/> In the second, the Justice Department joined a ''[[qui tam]]'', or whistleblower, lawsuit brought by a former sales rep over off-label marketing of three drugs: [[Lotrel]] and [[Valturna]] (both [[hypertension]] drugs), and the diabetes drug, [[Starlix]].<ref name=DOJ2013/> Twenty-seven states, the District of Columbia and Chicago and New York also joined.<ref name=NYTapril2013/> | ||