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Pharma Compliance Alert
Pharma Compliance Alert is your FREE source for the latest compliance news and analysis, delivered directly to your e-mail inbox every week
Issue 52, December 31, 2008
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FDA: HUMIRA ad misleading
Abbott’s American Academy of Dermatology post meeting news ad for HUMIRA misbrands the drug... -
Court dismisses off-label suit against Amgen
Amgen will not have to face a lawsuit from seven small health benefit plans that claimed the... -
Amgen, Immunex reach pricing settlement with Wisconsin
Amgen and Immunex agreed to pay a combined $1.7 million to settle charges they defrauded...
Issue 51, December 24, 2008
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FTC accuses Ovation of price gouging
The Federal Trade Commission (FTC) filed suit in U.S. District Court in Minnesota against Ovation... -
Texas AG accuses Janssen of fraud
The Texas attorney general alleges Janssen Pharmaceutica used kickbacks and false marketing to... -
FDA warns Victory Pharma for misleading sales aid
A Victory Pharma sales aid minimizes risks, presents misleading safety information, and omits...
Issue 50, December 17, 2008
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Senator questions Wyeth about ghostwriting
Senator Charles Grassley (R-IA) believes Wyeth paid ghostwriters to create articles favorable to... -
PhRMA releases new DTC advertising guidelines
Five months after updating its Code on Interactions with Healthcare Professionals, the... -
Massachusetts council announces marketing guidelines
Massachusetts will become the most restrictive state for pharmaceutical marketing if regulations...
Issue 49, December 10, 2008
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FDA warns AstraZeneca for alleged off-label promotion
An AstraZeneca sales representative allegedly promoted the company’s antipsychotic Seroquel... -
Court documents: AstraZeneca knew about Seroquel diabetes risks in 2000
It just got tougher for AstraZeneca to defend itself in lawsuits centering on its antipsychotic... -
Cleveland Clinic, Penn Medicine to post physician ties to pharma companies
Cleveland Clinic and the University of Pennsylvania are taking steps toward transparency regarding... -
Pharmaceutical settlements help government recover $2.35B
During fiscal year (FY) 2008, government enforcement efforts led to 455 criminal actions and 337...
Issue 48, December 3, 2008
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Bayer to pay $97.5M to settle kickback claims
Bayer HealthCare agreed to pay $97.5 million to settle claims it paid diabetic suppliers to convert... -
Actelion receives FDA warning letter for flash card
A flash card for Actelion’s Tracleer tablets presents unsubstantiated superiority claims and...
Issue 47, November 26, 2008
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Nevada AG claims pharma companies marketed products deceptively
Nevada Attorney General Catherine Cortez Masto filed suit against Wyeth and Pfizer, claiming... -
Court documents allege physician asked J&J to finance research center
Documents produced as part of a class action lawsuit against Johnson & Johnson (J&J) claim... -
Abbott to pay $184M to settle anti-trust claims
Abbott Laboratories agreed to pay $184 million to settle claims it created a monopoly with its... -
NH data mining ban upheld
The First Circuit Court of Appeals in Boston upheld a New Hampshire law prohibiting the sale of... -
McKesson settles pricing suit
McKesson agreed to pay $350 million to settle all private party claims relating to First... -
Shionogi direct mailers misleading, FDA says
Shionogi USA Inc.’s Professional NDC Sheet and a Cardinal Health NDC Sheet (direct mailers...
Issue 46, November 19, 2008
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Correction
Dan Dovdavany, JD, senior corporate counsel, investigations, at sanofi-aventis, was incorrectly... -
CA court rules Wyeth liable for injuries caused by generic medication
San Francisco’s First District Court of Appeal ruled Wyeth could be held liable for injuries... -
Florida judge dismisses RICO case against AstraZeneca
AstraZeneca will not face racketing charges related to its promotion of the antipsychotic Seroquel... -
OIG reviews NJ, Wisconsin false claims acts
Wisconsin’s False Claims Act meets the requirements set forth in the Deficit Reduction Act of... -
Pharma settlements help DOJ recover $1.34B in FY 2008
The Department of Justice (DOJ) recovered $1.34 billion through fraud and false claims settlements...
Issue 45, November 12, 2008
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Panel provides tips for responding to potential violations
Compliance officers need to get out of their offices and interact with employees, Liz Lewis, JD... -
Calls for industry transparency likely to increase
Transparency will be a huge frontier for pharmaceutical companies over the next three to four years... -
Senate investigating J&J payments to psychiatric associations
The Senate Committee on Finance is looking into Johnson & Johnson’s payments or benefits... -
Scrutiny of Vytorin marketing continues
The Department of Justice (DOJ) and 35 state attorneys general are investigating how Merck and...
Issue 44, November 5, 2008
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Amgen brochure misleading, FDA warns
Amgen’s direct-to-consumer patient brochure for Senispar tablets improperly omits and... -
Schering-Plough settles pricing case in Missouri
Schering-Plough agreed to pay $31 million to resolve allegations of pricing fraud in Missouri... -
Compliance not a one-person job
Pharmaceutical companies need to think about the big picture in order to integrate compliance... -
DOJ investigates hundreds of drugs in whistleblower cases
The Department of Justice (DOJ) is currently deciding whether to intervene in more than 150... -
Supreme Court hears arguments in preemption case
The Supreme Court will determine whether consumers can sue pharmaceutical companies for injuries...
Issue 43, October 29, 2008
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University of Minnesota considers gift ban
The University of Minnesota is considering one of the strictest bans on gifts from the... -
Lilly nears federal Zyprexa settlement
Eli Lilly’s total legal expenses for suits relating to its antipsychotic medication Zyprexa... -
GSK joins disclosure parade
The list of pharmaceutical companies that will disclose payments to physicians is getting longer...
Issue 42, October 22, 2008
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Wyeth releases its side of story for upcoming preemption case
The Supreme Court is set to begin hearing arguments in Wyeth v. Levine November 3, and Wyeth issued... -
Congress investigating Bayer advertising claims
Representatives John Dingell (D-MI) and Bart Stupak (D-MI) continue to examine pharmaceutical... -
Wisconsin medical society bans gifts from pharma companies
To avoid unnecessary conflicts of interest, Wisconsin physicians will no longer accept gifts from... -
Pfizer to settle Bextra, Celebrex claims for $894M
Pfizer has agreed in principle to pay $894 million to settle all lawsuits related to its...
Issue 41, October 15, 2008
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FDA warns Bayer about YAZ ads
Two 60-second direct-to-consumer advertisements for Bayer’s birth control pill YAZ overstate... -
DOJ withdraws motion against Ranbaxy
Generic drug maker Ranbaxy agreed to turn over audits to the Department of Justice (DOJ), and in... -
J&J paid $68M to settle birth-control patch lawsuits
Johnson & Johnson paid at least $68.7 million to settle hundreds of lawsuits by women who claim... -
Pfizer accused of suppressing Neurontin study
Pfizer marketing executives allegedly knew Neurontin, an epilepsy drug, did not effectively treat...
Issue 40, October 8, 2008
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GSK settles Paxil suit
GlaxoSmithKline (GSK) will pay $40 million to settle a class action lawsuit with 42,000 health... -
California appeals court rules FDA label doesn't protect manufacturer
The California Fifth District Court of Appeal in Fresno reinstated a Modesto woman’s suit... -
AstraZeneca, Bristol-Myers Squibb face additional trials for fraudulent pricing
U.S. District Judge Patti Saris certified two nationwide classes and ruled each class would have a... -
OIG to focus on drug pricing fraud
The OIG will continue to scrutinize pharmaceutical drug pricing practices as part of the 2009 OIG... -
Florida becomes ninth state to sue Merck because of Vioxx
Florida alleges Merck deceptively marketed and promoted Vioxx by failing to disclose its side... -
Eli Lilly to pay $62M for improperly marketing Zyprexa
Eli Lilly agreed to pay $62 million to 32 states and the District of Columbia to resolve...
Issue 39, October 1, 2008
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Exec sentenced to probation in Serono fraud case
Rudolph Liedtke, president of RJL Sciences, will pay $10,000 and serve three years of probation for... -
Pharma companies to disclose payments to physicians
Transparency is coming to a pharmaceutical company near you. Eli Lilly and Merck each announced... -
First Amendment not enough to dismiss off-label prosecution
Eastern District of New York Judge Eric N. Vitaliano ruled the First Amendment’s free speech... -
FDA warns five companies for incomplete or false advertising
Shire, Johnson & Johnson, Novartis, Mallinckrodt, and Eli Lilly all received warning letters... -
Cephalon finalizes $425M false claims settlement
Cephalon agreed to pay $425 million in civil and criminal penalties and entered into a corporate...
Issue 38, September 24, 2008
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REMS represent big change for industry
Risk Evaluation and Mitigation Strategies (REMS) could represent the biggest change to drug... -
Lilly CEO warns gift ban in Massachusetts could hurt innovation
A bill recently signed into law in Massachusetts could stifle clinical research in the state and... -
FDA issues warning letters to Ranbanxy
Two of generic drug manufacturer Ranbaxy’s plants allegedly violated U.S. current Good... -
Drug manufacturer to pay Massachusetts $1.8M
Boehringer Ingelheim Roxane, Inc. (Roxane), a Columbus, OH based drug manufacturer, will pay...
Issue 37, September 17, 2008
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Grassley: No disclosure, no funding from NIH
Senator Charles Grassley (R-IA) wants the National Institutes of Health (NIH) to withdraw funding... -
Allegedly inflated drug prices cost Abbott $28M
Abbott Laboratories will pay Texas $28 million to resolve allegations the company fraudulently... -
Globalization one of FDA's emerging trends
The number of drug products manufactured overseas and the numbers of sites that manufacture drug... -
Pfizer creates Web site on medication safety
Pfizer launched a new Web site Monday to provide patients and healthcare professionals with...
Issue 36, September 10, 2008
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Psychiatric journal to disclose industry ties
The editor in chief of Psychiatric Times announced the journal will disclose potential conflicts of... -
Judge throws out McKesson pricing suit
U.S. District Judge Patti Saris dismissed one potential class-action lawsuit against McKesson Corp... -
Journal ad for Bystolic misleading
Forest Laboratories’ eight-page journal ad for Bystolic claims the drug is safer and more... -
Idaho latest to sue Lilly because of Zyprexa
Idaho became the latest state to sue Eli Lilly for the way it marketed its antipsychotic drug... -
Documents unsealed in Lilly class action suit
Eli Lilly may have a tougher time defending its marketing for its antipsychotic Zyprexa after a... -
Congressmen widen probe of Vytorin safety
Reps. John Dingell (D-MI) and Bark Stupak (D-MI) asked Merck CEO Richard T. Clark and...
Issue 35, September 3, 2008
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Stryker files suit against DOJ, OIG
Stryker Corp. is suing the Department of Justice (DOJ) and Office of Inspector General (OIG) for... -
Stanford to stop accepting industry funding for CME
Stanford became the latest academic institution to limit how much funding it will accept from... -
Sandoz receives FDA warning letter
An FDA inspection revealed significant deviations from Good Manufacturing Practice at... -
Amgen changes marketing practices for Aranesp
Amgen will no longer offer rebates to oncology clinics for their use of the...
Issue 34, August 27, 2008
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FDA issues final rule on label changes
Pharmaceutical and medical device companies are only obligated to rush out warnings when they have...
Issue 33, August 20, 2008
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OIG approves four state False Claims Acts
The OIG approved the new State False Claims Acts for California, Georgia, Indiana, and Rhode... -
Pharmaceutical companies object to proposed lawsuit disclosure
A proposal by the Financial Accounting Standards Board (FASB) has drawn fire from at least six... -
Senators introduce anti-preemption bill
Senators Edward Kennedy (D-MA) and Patrick Leahy (D-VT) introduced a bill designed to overturn the... -
States, NEJM editors against preemption
Forty-seven states and the editors of the New England Journal of Medicine (NEJM) don’t want...
Issue 32, August 13, 2008
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FDA toughens conflict-of-interest rules for advisory board members
Outside specialists will be excluded from FDA advisory panels if they have a personal financial... -
FDA considers annual clinical trials safety report
New FDA draft guidance would change the way clinical trial sponsors report safety data. -
Wyeth's promotion of Protonix being investigated
The U.S. Attorney’s Office in Massachusetts is looking into how Wyeth marketed its ulcer drug... -
Massachusetts governor signs disclosure law
Massachusetts became the latest state to require disclosure of industry gifts to physicians, but...
Issue 31, August 6, 2008
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FDA to get more power?
The FDA will be able to levy fines, order drug recalls, and restrict drug-industry advertising if... -
Lilly reps allegedly trained to downplay Zyprexa risks
According to court documents, Eli Lilly knew about the connection between Zyprexa and diabetes, but...
Issue 30, July 30, 2008
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We need your help
Your feedback is the most important tool we have. Please help us meet your needs by completing a... -
Three-fourths of physicians will see sales reps any time
A recent survey represents some good news for the pharmaceutical and medical device industries... -
California appeals court throws out pricing case
Pfizer and 18 other pharmaceutical companies learned they will not face charges of pricing fraud in... -
Alabama sets hearing date for Bristol-Myers Squibb case
Alabama Attorney General Troy King successfully prosecuted AstraZeneca, GlaxoSmithKline, and... -
FDA to Wyeth: Stop using flashcard
A flashcard for Wyeth’s BeneFIX presents unsubstantiated claims that suggest the drug is... -
Congress: When did FDA know about problems with Ranbaxy drugs?
Representatives Bart Stupak (D-MI) and John Dingall (D-MI) are trying to determine when the FDA... -
GAO criticizes FDA oversight of off-label promotion
The FDA takes too long to warn a pharmaceutical company about off-label promotion, according to a...
Issue 29, July 23, 2008
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Bristol-Myers Squibb settlement divided among states
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Merck to begin Vioxx payments
Merck expects to begin distributing $4.85 billion to settle lawsuits by people who claimed they... -
Massachusetts House removes gift ban from bill
The Massachusetts House unanimously approved a healthcare reform bill, but without the gift ban... -
False Claims Act bill moves to full House
A bill to clarify and strengthen the False Claims Act (FCA) moved out of the House Judiciary... -
Life Sciences Compliance Survey
Your feedback is the most important tool we have. Please help us meet your needs by completing a...
Issue 28, July 16, 2008
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Vermont psychiatrists receive most money from pharma companies
Pharmaceutical companies increased spending on marketing in Vermont by 33 percent for fiscal year... -
Bristol-Myers Squibb to clean up facilities
Bristol-Myers Squibb (BMS) will spend $3.65 million to reduce the output of ozone-depleting... -
Amgen settles with Ortho Biotech for $200M
Amgen will pay Ortho Biotech $200 million to end a two and a half year antitrust lawsuit over the... -
Texas AG suing generic drug makers
Makers of brand-name prescription drugs aren’t the only ones being accused of defrauding the... -
FDA investigating generics manufacturer for falsifying records
Indian generics manufacturer Ranbaxy Laboratories will provide internal documents to federal... -
PhRMA Code's revised guidelines contain some surprises
The PhRMA Code’s elimination of small, practice-related gifts to healthcare professionals...
Issue 27, July 9, 2008
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DOJ swamped with whistleblower lawsuits
More than 500 cases involving potential fraud by healthcare and pharmaceutical companies are part... -
Novartis, GlaxoSmithKline to appeal Alabama verdict
Novartis and GlaxoSmithKline (GSK) both plan to appeal a jury verdict ordering them to pay $114... -
Pfizer changes its CME funding
Pfizer will no longer provide funding for physician continuing medical education provided by... -
Judge urges Eli Lilly to settle Zyprexa suit
The legal woes for Eli Lilly and its antipsychotic drug Zyprexa continue.
Issue 26, July 2, 2008
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McKesson may settle drug pricing suit
A pair of rulings in Boston may push McKesson Corp. to settle a suit centered on allegations the... -
Novartis, GlaxoSmithKline pricing case goes to the jury
After two weeks of testimony, a jury will decide whether Novartis and GlaxoSmithKline defrauded the... -
Pre-emption bill could impact Supreme Court case
A bill introduced in the House of Representatives could have a negative impact on pharmaceutical... -
Pfizer pays clean air fine
Pfizer became the first pharmaceutical company to pay a fine under the PharmaMACT, a 2000 law...
Issue 25, June 25, 2008
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Prosthetics company investigated for fraud
FBI agents raided the Georgia offices of Preferred Prosthetics & Orthotics Inc. looking for... -
OIG collects $2.2 billion in healthcare fraud
Bristol-Myers Squibb’s $499 million settlement for alleged price fraud, kickbacks, and False... -
Two-thirds of Americans want to know about payments to physicians
Senators Charles Grassley (R-IA) and Herb Kohl (D-WI) gained support from the pharmaceutical... -
Probe into GSK's Paxil expands
More questions are being raised about GlaxoSmithKline’s (GSK) antidepressant Paxil, according... -
Damages deemed too high in AstraZeneca fraud case
AstraZeneca lost its bid to have a fraud verdict in Alabama overturned, but the judge did rule the... -
Prescription information not for sale in California
Pharmaceutical companies will not be able to obtain patient prescription information from...
Issue 24, June 18, 2008
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Wright Medical under 'informal' investigation by SEC
The Securities and Exchange Commission (SEC) is informally investigating Wright Medical Technology... -
Grassley wants FDA to investigate Paxil
Senator Charles Grassley (R-IA) asked the FDA to scrutinize information GlaxoSmithKline (GSK... -
Pharmaceutical companies put temporary hold on ads
Merck, Johnson & Johnson (J&J), and Pfizer will stop marketing new drugs to consumers for... -
OIG: FDA takes too long to review generic drugs
The FDA exceeded the mandated review period for almost half of the Abbreviated New Drug... -
We need your help
Are you looking for information about a compliance topic? What would you like to receive expert...
Issue 23, June 11, 2008
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Vioxx users can't sue for medical monitoring
Merck will not have to pay for electrocardiograms and follow-up consultations with cardiologists... -
FDA sending out fewer warning letters
The number of warning letters sent by the FDA dropped by more than half in the past seven years... -
DOJ backs Wyeth in preemption case
The Department of Justice (DOJ) filed a brief with the Supreme Court supporting Wyeth in an... -
Senators to introduce anti-preemption bill
Medical device makers benefited from a Supreme Court ruling in favor of preemption, but now two... -
Device company settles alleged FCPA violation
AGA Medical Corporation will pay a $2 million criminal fine to settle allegations it violated the...
Issue 22, June 4, 2008
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Merck gets good news on Vioxx front
One week after Merck agreed to pay $58 million to settle claims it downplayed the risks of Vioxx in... -
Vermont Senate unhappy with federal disclosure bill
While members of the pharmaceutical and medical device industries throw their support behind a... -
Disclosure bill gains more industry support
Senators Charles Grassley (R-IA) and Herb Kohl (D-WI) can thank Eli Lilly for starting a trend. -
California Senate approves sale of pharmacy records
In contrast to states that have tried and failed to ban data mining, California is now embracing...
Issue 21, May 28, 2008
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McKisson faces suit over drug prices
McKisson, the biggest U.S. drug distributor, is accused of manipulating its average wholesale price... -
Biovail agrees to $24.6M settlement for kickbacks
Illegal kickbacks used to induce physicians to prescribe Cardizem LA will cost Biovail... -
Arkansas sues AstraZeneca for misleading marketing
Arkansas Attorney General Dustin McDaniel filed suit against AstraZeneca for allegedly illegal... -
Medtronic settles false claim allegations
Medtronic Spine LLC, formerly known as Kyphon Inc., will pay $75 million to settle a lawsuit... -
Merck to pay additional $58M for Vioxx
Merck’s costs for the withdrawn painkiller Vioxx continue to mount.
Issue 20, May 21, 2008
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DOJ files statement of interest in suit against Pfizer
The Department of Justice (DOJ) filed a statement of interest in a whistleblower lawsuits brought... -
Pfizer discloses grants online
Saying it is “committed to the principle of transparency,” Pfizer is following Eli... -
NY governor wants physicians to disclose gifts
New York Governor David Paterson isn’t waiting for the federal government to limit gifts from... -
Eli Lilly supports revised gift reporting bill
Eli Lilly is breaking ranks with other pharmaceutical companies—again.
Issue 19, May 7, 2008
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Merck extends signup deadline for Vioxx settlement
Patients who claim they were harmed by Merck’s now withdrawn pain reliever Vioxx have until... -
Merck warned about manufacturing plant
FDA investigators documented “significant deviations from current good manufacturing... -
We need your help
Are you looking for information about a compliance topic? What would you like to receive expert... -
FDA: Novartis promotional magnet violates rules
A Partial Seizure Lenticular Magnet for Novartis’ Trileptal misbrands the drug because it... -
Facts missing from ZymoGenetics press release
The FDA wants ZymoGenetics to revise a press release for the company’s first product... -
Delay in generic Wellbutrin release leads to possible class-action suit
Senior U.S. District Judge Bruce W. Kauffman granted class action status to an antitrust lawsuit... -
Complaint over gift-ban bill could backfire on pharma company
A letter from a GlaxoSmithKline (GSK) executive to Massachusetts Governor Deval Patrick and...
Issue 18, April 30, 2008
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GlaxoSmithKline, Novartis heading to court together
Pharmaceutical companies took another hit in the ongoing litigation in Alabama over drug pricing... -
Missing information leads to warning for Viagra ad
The FDA issued a warning letter to Pfizer for an online Viagra ad because the ad on CNN.com failed... -
Former Bristol-Myers Squibb executive indicted
Andrew G. Bodnar, MD, a former senior executive vice president for Bristol-Myers Squibb, faces... -
Group wants to ban gifts to medical school students, faculty
Academic medical centers should not allow students, faculty, and staff members to accept gifts from...
Issue 17, April 23, 2008
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Washington says 'no' to anti-data mining law
Another attempt to ban data mining ended unsuccessfully when a bill in Washington state failed to... -
Merck accused of misrepresenting Vioxx data
New allegations against Merck and its arthritis medication Vioxx could keep the FDA from relaxing...
Issue 16, April 16, 2008
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Louisiana AG drops suit against Amgen
Louisiana’s new attorney general (AG) decided not to follow through on his... -
FDA warns GlaxoSmithKline about missing information
GlaxoSmithKline (GSK) failed to report all of the post-marketing data it collected on its diabetes... -
Court rules in favor of Pfizer, GlaxoSmithKline
Another case, another preemption win for the pharmaceutical and medical device industries. -
Pharmaceutical companies agree to reveal funding
Senator Charles Grassley (R-IA) will get the grant information he wants from some of the biggest...
Issue 15, April 9, 2008
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CT AG sues FDA over OxyContin
Connecticut Attorney General Richard Blumenthal is suing the FDA to force the agency to put tougher... -
Senator Grassley questions Amgen rebates
Amgen, already answering questions posed by members of the House of Representatives about bundling... -
Congress investigating marketing, advertising of anemia drugs
Did Johnson & Johnson and Amgen improperly market their erythropoiesis-stimulating agents... -
False Claims Act Corrections Act moves out of committee
The Senate could soon be taking up the question of whether the courts have misinterpreted the...
Issue 14, April 2, 2008
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Otsuka to pay $4M for off-label promotion
Off-label promotion of Abilify will cost Otsuka American Pharmaceutical Inc. more than $4 million... -
Lilly settles lawsuit in Alaska
A jury in Alaska will not get to decide if Eli Lilly lied about the side effects of its... -
File card for Avinza misleading
Ligand Pharmaceuticals' file card for Avinza "minimizes and fails to communicate important risk...
Issue 12, March 26, 2008
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Abbott accused of blocking generic
Eighteen states and the District of Columbia are so sure Abbott Laboratories and Solvay's Fournier... -
Former InterMune CEO charged in off-label marketing scheme
Scott Harkonen, the former CEO of InterMune, was indicted last week for alleged fraudulent...
Issue 11, March 19, 2008
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HCPro, Inc. launches new logo and tagline as part of its new corporate branding initiative
HCPro, Inc. launches new logo and tagline as part of its new corporate branding initiative -
Representatives introduce version of Physician Payment Sunshine Act
Congress took one step closer to requiring pharmaceutical and medical device companies to disclose... -
Massachusetts Senate bans gifts to physicians
The Massachusetts Senate approved the first state ban on gifts to physicians last week, but the... -
Connecticut suing Lilly over Zyprexa
Eli Lilly, currently defending itself against a lawsuit in Alaska over Zyprexa marketing, faces yet... -
Some scientists turn down money from pharma industry
A group of academic scientists decided not to accept money from the pharmaceutical and medical... -
E-mail allegedly promoting off-label uses could hurt Lilly settlement talks
An e-mail in which Lilly's incoming CEO allegedly encouraged off label promotions was not admitted... -
Senator wants information on Schering-Plough marketing plan
Schering-Plough is facing questions from Congress about its plans to boost sales of its cholesterol...
Issue 10, March 12, 2008
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Pharmaceutical companies settle AWP litigation
All but two pharmaceutical companies have agreed to pay $125 million to settle allegations they... -
DOJ subpoenas Allergan's Botox marketing records
The Department of Justice (DOJ) is looking into how Allergan marketed Botox, according to a company... -
Washington tries to ban data mining
Legislators in Washington state are the latest to try to curb data mining, according to an article...
Issue 9, March 5, 2008
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Supreme Court deadlocks on Pfizer case
Pfizer and its Warner-Lambert division won't get any help from the Supreme Court when it comes to... -
Massachusetts considering ban on industry gifts to physicians
A new bill introduced in the Massachusetts senate would ban all gifts from pharmaceutical companies... -
OIG, Congress still concerned with physician-industry relationships
OIG Assistant Inspector General for Legal Affairs, Gregory E. Demske, detailed the risks associated... -
Keep compliance concerns on sales staff's radar
Keep your compliance training up-to-date with HCPro's elearning courses. Our solutions are designed... -
Keep compliance concerns on sales staff's radar
Keep your compliance training up-to-date with HCPro's elearning courses. Our solutions are designed... -
Lilly heads to Alaska court
FDA approval will be the lynchpin in Eli Lilly's defense of its antipsychotic drug Zyprexa in an...
Issue 8, February 27, 2008
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Supreme Court rules in favor of device makers
The Supreme Court handed down some good news for medical device makers last Wednesday when it ruled... -
Judge refuses to dismiss whistleblower suit against J&J
US District Court Judge Patti Saris said a whistleblower suit against Johnson &Johnson's... -
Montana AG sues Janssen, AstraZeneca
Montana Attorney General Mike McGrath became the latest to file suit against Janssen and... -
Replidyne receives warning letter for data submitted for NDA
A biopharmaceutical company in Louisville, CO., learned the hard way that using another company's...
Issue 7, February 20, 2008
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FDA may ease restrictions on off-label information
Pharmaceutical companies may get more leeway in how they distribute off-label information based on... -
Lawsuit claims Cephalon "bought off" generic makers
Cephalon may have been so eager to protect its top selling drug, Provigil, that it illegally...
Issue 6, February 13, 2008
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Merck to pay $650M to settle fraud allegations
Allegedly failing to pay rebates and improperly marketing Vioxx, Zocor, and Pepcid will cost Merck... -
Pharmaceutical marketing must be complaint
Pharmaceutical companies need to find ways that are above reproach to communicate about their...
Issue 5, January 30, 2008
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Almost one fifth of physicians won't see sales reps
Nineteen percent of office-based physicians refuse to see pharmaceutical and medical device sales... -
Federal grand jury to examine Vioxx marketing
A federal grand jury is investigating whether Merck promoted its painkiller Vioxx for off-label... -
Democrats oppose plan on drug label changes
Eight congressional Democrats want the FDA to reconsider its plan to allow pharmaceutical and... -
Lilly fine could reach $1B
Eli Lilly could set a new record for the largest fine ever paid by a pharmaceutical company... -
More Vytorin fallout for Merck, Schering-Plough
Merck and Schering-Plough are facing a lawsuit over their cholesterol drug Vytorin, according to... -
Sepracor says it owes Medicare $80M to $100M
During an internal audit, Sepracor found potential errors in its best price reporting between 2002... -
Create a code of conduct to establish a culture of compliance
Pharmaceutical companies should stress why compliance is the right thing to do when trying to...
Issue 4, January 23, 2008
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EU officials looking into pharmaceutical antitrust
European Union (EU) antitrust officials are raiding pharmaceutical companies to find out why so few... -
New Jersey AG investigating Amgen
New Jersey Attorney General (AG) Anne Milgram is investigating whether Amgen violated patient... -
Minnesota health system bans pharma logos
Pharmaceutical sales representatives won't have to worry about tracking gifts provided to...
Issue 3, January 16, 2008
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Former sales reps file suits against Amgen
Two former Amgen sales representatives are seeking damages against the company in arbitration and... -
Dey, Takeda to pay Alabama $6.75M to settle Medicaid fraud charges
Dey LP and Takeda Pharmaceuticals North America Inc. have agreed to pay the state of Alabama $6.75... -
D.C. passes bill to license pharmaceutical representatives
The D.C. Council passed the SafeRx Act of 2007 last week by a 7 to 6 vote, becoming the first...
Issue 2, January 9, 2008
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Solicitor General argues for preemption
In an opinion posted on the Department of Justice Web site, U.S. Solicitor General Paul Clement... -
Maine data mining law struck down
A federal judge in Maine struck down a law that would have allowed physicians to keep their...
Issue 1, January 2, 2008
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OIG releases audit of AMPs and ASPs
The OIG identified 22 drug codes with average sales prices (ASP) that exceeded the average... -
FDA announces user fee rates for DTC voluntary review program
Pharmaceutical companies that want the FDA to review direct-to-consumer (DTC) advertising will pay... -
Pfizer sued over Lipitor marketing
Pfizer's former director of outcomes management strategies claimed Pfizer promoted sales of Lipitor...
Issue 47, November 26, 2008
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FDA warns Protherics for Web page, fact sheet
Protherics Inc.’s Web page and fact sheet for its investigational new drug Voraxaze misbrand...
Issue 34, August 27, 2008
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More questions raised about Vioxx
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States consider ban on data mining
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GSK to post grant information quarterly
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