Editing GSK plc (section)

====Overview====
In July 2012, GSK pleaded guilty in the United States to criminal charges, and agreed to pay US$3{{nbsp}}billion, in what was the [[List of Largest Pharmaceutical Settlements|largest settlement]] until then between the Justice Department and a drug company. The US$3{{nbsp}}billion included a criminal fine of US$956,814,400 and forfeiture of US$43,185,600. The remaining US$2{{nbsp}}billion covered a civil settlement with the government under the [[False Claims Act]]. The investigation was launched largely on the basis of information from four whistleblowers who filed [[qui tam]] (whistleblower) lawsuits against the company under the False Claims Act.<ref name="USDOJJuly2012">[https://www.justice.gov/opa/pr/2012/July/12-civ-842.html "GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data"] {{Webarchive|url=https://web.archive.org/web/20140909141736/http://www.justice.gov/opa/pr/2012/July/12-civ-842.html |date=9 September 2014 }}, United States Department of Justice, 2 July 2012.{{pb}}
Katie Thomas and Michael S. Schmidt, [https://www.nytimes.com/2012/07/03/business/glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement.html "Glaxo Agrees to Pay $3 Billion in Fraud Settlement"] {{Webarchive|url=https://web.archive.org/web/20170302145001/http://www.nytimes.com/2012/07/03/business/glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement.html |date=2 March 2017 }}, ''[[The New York Times]]'', 2 July 2012.{{pb}}
Simon Neville, [https://www.theguardian.com/business/2012/jul/03/glaxosmithkline-fined-bribing-doctors-pharmaceuticals "GlaxoSmithKline fined $3bn after bribing doctors to increase drugs sales"], ''[[The Guardian]]'', 3 July 2012.</ref>

The charges stemmed from GSK's promotion of the anti-depressants Paxil ([[paroxetine]]) and Wellbutrin ([[bupropion]]) for unapproved uses from 1998 to 2003, specifically as suitable for patients under the age of 18, and from its failure to report safety data about Avandia ([[rosiglitazone]]), both in violation of the [[Federal Food, Drug, and Cosmetic Act]]. Other drugs promoted for unapproved uses were two inhalers, Advair ([[fluticasone/salmeterol]]) and Flovent ([[fluticasone propionate]]), as well as Zofran ([[ondansetron]]), Imitrex ([[sumatriptan]]), Lotronex ([[alosetron]]) and Valtrex ([[valaciclovir]]).<ref name=USDOJJuly2012/>

The settlement also covered reporting false best prices and underpaying rebates owed under the [[Medicaid Drug Rebate Program]], and kickbacks to physicians to prescribe GSK's drugs. There were all-expenses-paid spa treatments and hunting trips for doctors and their spouses, speakers' fees at conferences, and payment for articles [[Medical ghostwriter|ghostwritten]] by the company and placed by physicians in medical journals.<ref name=USDOJJuly2012/> The company set up a ghostwriting programme called CASPPER, initially to produce articles about Paxil but which was extended to cover Avandia.<ref>[[Max Baucus]], [[Chuck Grassley]], [http://finance.senate.gov/newsroom/chairman/download/?id=a5c07780-6351-4905-8c63-52e4a7a7a66b "Finance Committee Letter to the FDA Regarding Avandia"] {{Webarchive|url=https://web.archive.org/web/20100805051726/http://finance.senate.gov/newsroom/chairman/download/?id=a5c07780-6351-4905-8c63-52e4a7a7a66b |date=5 August 2010 }}, United States Senate Finance Committee, 12 July 2010.<br />
Jim Edwards, [http://www.cbsnews.com/news/inside-gsks-cassper-ghostwriting-program/ "Inside GSK's CASSPER Ghostwriting Program"], CBS News, 21 August 2009.</ref>

As part of the settlement GSK signed a five-year [[corporate integrity agreement]] with the [[Department of Health and Human Services]], which obliged the company to make major changes in the way it did business, including changing its compensation programmes for its sales force and executives, and to implement and maintain transparency in its research practices and publication policies.<ref name=USDOJJuly2012/> It announced in 2013, that it would no longer pay doctors to promote its drugs or attend medical conferences, and that its sales staff would no longer have prescription targets.<ref name=Reuters17Dec2013>[http://sustainability.thomsonreuters.com/2013/12/17/gsk-stop-paying-doctors-major-marketing-overhaul "GSK to stop paying doctors in major marketing overhaul"] {{Webarchive |url=https://web.archive.org/web/20141028041032/http://sustainability.thomsonreuters.com/2013/12/17/gsk-stop-paying-doctors-major-marketing-overhaul/ |date=28 October 2014 }}, Thomson/Reuters, 17 December 2013.</ref>