Life Sciences Articles by Topic: Off-Label Promotion
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Pharma Compliance Alert, Issue 19, May 13, 2009
Los Angeles Superior Court Judge Victoria G. Chaney denied class action status to plaintiffs...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 14, April 27, 2009
The Department of Justice subpoenaed documents relating to Smith & Nephew’s ultrasound...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 14, April 27, 2009
Shane Doyle, 32, of Winchester, MA, pleaded guilty to felony misbranding, according to the...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 14, April 27, 2009
Government investigators are examining allegations that Biomet improperly sold, promoted, and...
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Pharma Compliance Alert, Issue 13, April 1, 2009
Mary Holloway, 47, of Branchburg, NJ, pleaded guilty to violating the Food, Drug, and Cosmetic Act...
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Pharma Compliance Alert, Issue 12, March 25, 2009
A grand jury is investigating Merck’s research, marketing, and selling activities for its...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 11, March 16, 2009
A Massachusetts grand jury is investigating a Stryker subsidiary’s promotion of its human...
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Pharma Compliance Alert, Issue 10, March 11, 2009
Johnson & Johnson and its subsidiary Janssen Pharmaceutica directed sales representatives to...
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Pharma Compliance Alert, Issue 10, March 11, 2009
Johnson & Johnson and its Janssen Pharmaceuticals unit must pay West Virginia roughly $4.5...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 10, March 9, 2009
The Department of Justice (DOJ) is investigating Medtronic’s promotion of its cardiac...
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Pharma Compliance Alert, Issue 9, March 4, 2009
A whistleblower lawsuit partially unsealed in Massachusetts accuses Amgen of engaging in illegally...
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Pharma Compliance Alert, Issue 9, March 4, 2009
Forest Laboratories allegedly improperly marketed its antidepressants Celexa and Lexapro for...
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Pharma Compliance Alert, Issue 8, February 25, 2009
The Department of Justice (DOJ) joined two whistleblower lawsuits filed against Johnson &...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 7, February 16, 2009
Justin Demming, of Wadsworth, OH, pleaded guilty to felony misbranding of a medical device...
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Pharma Compliance Alert, Issue 6, February 11, 2009
Bayer entered into a settlement with 27 states to resolve allegations it deceptively marketed its...
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Pharma Compliance Alert, Issue 6, February 11, 2009
In January, the FDA provided some much needed guidance for the pharmaceutical industry about when...
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Pharma Compliance Alert, Issue 6, February 11, 2009
Pharmaceutical manufacturers must make sure compliance and ethics are fully integrated into their...
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Pharma Compliance Alert, Issue 5, February 4, 2009
A $2.3 billion estimated settlement could eclipse Eli Lilly?s $1.4 billion payment to resolve...
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Pharma Compliance Alert, Issue 5, February 4, 2009
GlaxoSmithKline (GSK) is preparing to settle an ongoing investigation into the company’s...
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Pharma Compliance Alert, Issue 3, January 21, 2009
Eli Lilly’s tab for allegedly promoting its antipsychotic Zyprexa for off-label uses topped...
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Pharma Compliance Alert, Issue 2, January 14, 2009
Pharmaceutical and medical device manufacturers will find it easier to distribute journal articles...
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Pharma Compliance Alert, Issue 52, December 31, 2008
Amgen will not have to face a lawsuit from seven small health benefit plans that claimed the...
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Pharma Compliance Alert, Issue 50, December 17, 2008
Five months after updating its Code on Interactions with Healthcare Professionals, the...
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Pharma Compliance Alert, Issue 49, December 10, 2008
It just got tougher for AstraZeneca to defend itself in lawsuits centering on its antipsychotic...
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Pharma Compliance Alert, Issue 49, December 10, 2008
An AstraZeneca sales representative allegedly promoted the company’s antipsychotic Seroquel...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 49, December 8, 2008
The Prescription Project, a non-profit watchdog group, petitioned the FDA to require Abbott...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 48, December 1, 2008
Darnell Martin, 35, of Chicago, pleaded guilty to one count of making a false statement and one...
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Pharma Compliance Alert, Issue 47, November 26, 2008
Nevada Attorney General Catherine Cortez Masto filed suit against Wyeth and Pfizer, claiming...
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Pharma Compliance Alert, Issue 47, November 26, 2008
Documents produced as part of a class action lawsuit against Johnson & Johnson (J&J) claim...
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Pharma Compliance Alert, Issue 47, November 26, 2008
Protherics Inc.’s Web page and fact sheet for its investigational new drug Voraxaze misbrand...
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Pharma Compliance Alert, Issue 47, November 26, 2008
Shionogi USA Inc.’s Professional NDC Sheet and a Cardinal Health NDC Sheet (direct mailers...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 47, November 24, 2008
The Department of Justice (DOJ) is looking into the off-label use of Medtronic’s Infuse Bone...
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Pharma Compliance Alert, Issue 46, November 19, 2008
The Department of Justice (DOJ) recovered $1.34 billion through fraud and false claims settlements...
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Pharma Compliance Alert, Issue 46, November 19, 2008
AstraZeneca will not face racketing charges related to its promotion of the antipsychotic Seroquel...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 46, November 17, 2008
The Department of Justice (DOJ) recovered $1.34 billion through fraud and false claims settlements...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 46, November 17, 2008
The Department of Justice (DOJ) is investigating allegations that AtriCure, Inc., improperly...
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Pharma Compliance Alert, Issue 45, November 12, 2008
The Department of Justice (DOJ) and 35 state attorneys general are investigating how Merck and...
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Pharma Compliance Alert, Issue 44, November 5, 2008
Amgen’s direct-to-consumer patient brochure for Senispar tablets improperly omits and...
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Pharma Compliance Alert, Issue 43, October 29, 2008
Eli Lilly’s total legal expenses for suits relating to its antipsychotic medication Zyprexa...
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Pharma Compliance Alert, Issue 42, October 22, 2008
Pfizer has agreed in principle to pay $894 million to settle all lawsuits related to its...
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Pharma Compliance Alert, Issue 42, October 22, 2008
Representatives John Dingell (D-MI) and Bart Stupak (D-MI) continue to examine pharmaceutical...
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Pharma Compliance Alert, Issue 41, October 15, 2008
Pfizer marketing executives allegedly knew Neurontin, an epilepsy drug, did not effectively treat...
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Pharma Compliance Alert, Issue 41, October 15, 2008
Two 60-second direct-to-consumer advertisements for Bayer’s birth control pill YAZ overstate...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 1, October 13, 2008
Laboratory Corporation of America (LabCorp) is illegally marketing a blood test to detect ovarian...
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Pharma Compliance Alert, Issue 40, October 8, 2008
Eli Lilly agreed to pay $62 million to 32 states and the District of Columbia to resolve...
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Pharma Compliance Alert, Issue 40, October 8, 2008
Florida alleges Merck deceptively marketed and promoted Vioxx by failing to disclose its side...
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Pharma Compliance Alert, Issue 40, October 8, 2008
GlaxoSmithKline (GSK) will pay $40 million to settle a class action lawsuit with 42,000 health...
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Pharma Compliance Alert, Issue 39, October 1, 2008
Cephalon agreed to pay $425 million in civil and criminal penalties and entered into a corporate...
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Pharma Compliance Alert, Issue 39, October 1, 2008
Shire, Johnson & Johnson, Novartis, Mallinckrodt, and Eli Lilly all received warning letters...
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Pharma Compliance Alert, Issue 39, October 1, 2008
Eastern District of New York Judge Eric N. Vitaliano ruled the First Amendment’s free speech...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 39, September 29, 2008
Physicians and patients obtain most of their information about products online, said James M. Wood...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 38, September 22, 2008
Clinical or medical personnel should be on hand at trade shows to provide information about...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 37, September 15, 2008
The FDA and Immigration and Customs Enforcement executed a search warrant at Spectranetics...
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Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 37, September 15, 2008
Medtronic became the fourth major manufacturer investigated for improperly marketing its bile duct...
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Pharma Compliance Alert, Issue 36, September 10, 2008
Eli Lilly may have a tougher time defending its marketing for its antipsychotic Zyprexa after a...
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Pharma Compliance Alert, Issue 36, September 10, 2008
Idaho became the latest state to sue Eli Lilly for the way it marketed its antipsychotic drug...
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Pharma Compliance Alert, Issue 36, September 10, 2008
Forest Laboratories’ eight-page journal ad for Bystolic claims the drug is safer and more...
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Pharma Compliance Alert, Issue 35, September 3, 2008
Amgen will no longer offer rebates to oncology clinics for their use of the...
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Pharma Compliance Alert, Issue 35, September 3, 2008
Stryker Corp. is suing the Department of Justice (DOJ) and Office of Inspector General (OIG) for...
