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Issue 52, December 31, 2008

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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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