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Pharma Compliance Alert

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2009 | 2008 | 2007 | 2006

Issue 38, December 20, 2006

• NY Times reports Lilly promoted off-label; Lilly denies claims

  Eli Lilly promoted off-label uses for the schizophrenia and bipolar disorder drug Zyprexa, The New...

Issue 37, December 6, 2006

• NIH official faces criminal charges for deal with Pfizer

  A senior NIH scientist is facing up to a year in prison and a fine of $100,000 if convicted of...

• Swift generic biologics approval unlikely

  There’s little probability of action next year in the 110th Congress that would support...

• Merck affiliate settles Ohio pricing litigation for $952,925

  Dey, L.P, an affiliate of Merck KGaA, will pay $952,925 to settle a pricing suit brought by the...

Issue 36, October 29, 2006

• Gainsharing arrangement: improper inducement, but wouldn’t draw OIG sanctions

  A proposed gainsharing arrangement between a hospital and cardiac surgeons would constitute an...

Issue 35, November 22, 2006

• Omnicare pays $49.5 million to settle Medicaid fraud

  Omnicare, the nation’s largest provider of pharmacy services to long-term care facilities...

• States benefiting little from DRA, Part D, survey says

  Medicare Part D has not significantly reduced state Medicaid pharmacy costs, according to a recent...

Issue 34, November 15, 2006

• Pfizer breaks AHA pre-conference rules on data disclosure

  The American Heart Association cancelled a presentation of new data on Pfizer’s cholesterol...

Issue 33, November 8, 2006

• Court denies argument that "average wholesale price" shouldn’t be read literally

  A U.S. District Court in Boston has rejected an argument, made by several drug manufacturers, that...

• Mallinckrodt cited for omitting risk information from exhibit booth panels

  Mallinckrodt must change exhibit booth panels promoting MD-Gastroview and OptiMARK, because the...

Issue 32, November 1, 2006

• InterMune settles off-label charges for $37 million

  InterMune will pay $36.9 million and enter a corporate integrity agreement with the government to...

• AstraZeneca subpoenaed on Seroquel

  Alaska and California subpoenaed AstraZeneca last month for information related to the marketing of...

Issue 31, October 25, 2006

• NIH doctors accuse Lilly of manipulating medical guidelines

  Eli Lilly may have improperly influenced the development of professional guidelines for the...

• PBM Medco to pay $155 million false claims settlement

  Medco Health Solutions, the second largest pharmacy benefit manager in the US, will pay the...

Issue 30, October 18, 2006

• BioMarin receives warning letter for downplaying Orapred risks on website

  FDA says the website for BioMarin’s asthma drug Orapred down plays the drugs risks and...

• CMS improves drug benefit oversight with new MEDICS

  CMS has added four Medicare Drug Integrity Contractors (MEDICs) to help combat fraud related to the...

Issue 29, October 11, 2006

• UC Davis considers banning industry gifts, changing free sample system

  The University of California at Davis Medical Center may become the next major academic medical...

• Appeals court reinstates product liability suit against Warner-Lambert

  A federal appeals court last week reinstated a lawsuit against Warner-Lambert from a group of...

Issue 28, October 4, 2006

• Former rep blew whistle on Merck Sharp & Dohme resulting in ABPI suspension

  Offering special services only to high-prescribing physicians has resulted in Merck Sharp...

• Bayer safety study not disclosed to FDA

  Bayer did not inform the FDA about a potentially damaging retrospective study of its drug Trasylol...

• Schering settlement brings new scrutiny to off-label

  The recent Schering settlement and CIA are going to bring new scrutiny to pharmaceutical off-label...

Issue 27, September 27, 2006

• OIG 2007 work plan restates charge to follow fraud and abuse and false claims cl

  The Office of the Inspector General (OIG) released its 2007 Work Plan yesterday, which contains a...

• OIG advisory opinion: Little chance of anti-kickback violation from pharma donat

  Pharmaceutical companies and other healthcare stakeholders can provide funding to a charitable...

• OIG advisory opinion: PAP operating outside Part D benefit poses minimal fraud a

  An OIG advisory opinion posted yesterday outlines safeguards that minimize fraud and abuse in...

• FDA warning letter: DAVA sample request letter contains no risk information

  A sample request letter from DAVA Pharmaceuticals fails to include any risk information for the...

Issue 26, September 20, 2006

• DDMAC: Reliant Pharmaceuticals promotion doesn’t include any risk information

  Reliant Pharmaceuticals failed to communicate any risk information in promotions for its drug...

• Court dismisses class-action suit against Wyeth

  An Illinois court has affirmed a previous ruling to dismiss a plaintiff’s claim against Wyeth...

Issue 25, September 13, 2006

• DOJ joins whistleblower suit against Dey; Pfizer wins whistleblower suit of its

  The U.S. Department of Justice has intervened in a whistleblower suit against the drugmaker Dey...

• Stanford Medical Center joins others in pharma gift, sample ban

  Stanford Medical Center is the latest academic medical center to enact a policy prohibiting...

• Judge rejects P&G, Sanofi arguments against Boniva marketing

  A federal judge last week rejected an argument from Procter&Gamble and Sanofi Aventis claiming that...

• Pharmaceutical Compliance Forum accepting nominations for Compliance Best Practi

  The Pharmaceutical Compliance Forum is accepting nominations for first annual Compliance Best...

Issue 24, September 6, 2006

• OIG advisory opinion: Pharma, other donations to cancer charity pose little kick

  Pharmaceutical companies and other healthcare stakeholders can provide funding to a charitable...

• TAP, Abbott, Takeda reach $1.86 million settlement with Illinois AG

  TAP, Abbott, and Takeda have reached a $1.86 million deal with Illinois Attorney General Lisa...

Issue 23, August 30, 2006

• Schering-Plough pleads guilty to conspiracy, will sign CIA addendum

  Schering-Plough says its Schering Sales Corporation subsidiary will plead guilty to one count of...

• Compliance officer: Managing KOLs across departments is ’critical’

  Keeping track of your company’s relationships with KOLs is critical, not only within...

Issue 22, August 23, 2006

• OIG publishes guidelines for evaluating state false claims acts

  A new OIG publication out this week provides guidelines for evaluating whether or not state false...

• OIG: FDA’s Rx database flawed, pharmas largely at fault

  The FDA’s prescription drug database is inaccurate, largely due to insufficient reporting by...

Issue 21, August 16, 2006

• GSK reaches civil settlements for average wholesale price litigation

  GlaxoSmithKline reached civil settlements last week to resolve class-action claims alleging that...

• Congressional leaders probe NIH scientist’s pharmaceutical ties

  Members of the House Energy and Commerce Committee sent a letter to the National Institutes of...

Issue 20, August 9, 2006

• Pharma companies win significant drug pricing case in California

  AstraZeneca and several other pharmaceutical companies won a significant victory in a California...

• South Carolina AG files suit against five drug companies

  South Carolina Attorney General Henry McMaster has filed a lawsuit against five pharmaceutical...

• FDA warns Lilly about misleading information in ad

  An FDA warning letter says a brochure for Eli Lilly’s cancer drug Alimta failed to say what...

Issue 19, July 26, 2006

• New York law will help state crack down on Medicaid fraud

  New York will have increased power to investigate and prosecute Medicaid fraud under new...

• Pharma ties to FDA committee members to get greater scrutiny

  The FDA is taking a closer look at its process for letting people with drug industry ties serve on...

• MN governor proposes to make FDA DTC rules state law

  Minnesota Governor Tim Pawlenty introduced two new pieces of legislation last week in an effort to...

Issue 18, July 19, 2006

• Manage all physician interactions to ensure state-specific compliance

  Complying with state-by-state regulations means more than merely keeping track of the various...

• Undisclosed drug industry ties prompt tighter JAMA policies

  Authors of a recent study failed to disclose their financial ties to pharmaceutical companies and...

Issue 17, July 12, 2006

• NH Gov. signs Rx data restriction bill, AMA opt-out program goes into effect

  Within the last two weeks, pharmaceutical companies’ access to prescribing data has become...

• FDA developing new guidance for adaptive clinical trials

  The FDA is working on a series of guidance documents for developing adaptive approaches to clinical...

• OIG study highlights pharma, FDA post-market study failures

  Pharmas may see increased scrutiny as the result of a study that finds they often fail to fulfill...

• What you can do if confined by compassionate use study rules

  Managed markets teams cannot use the compassionate use program/regulatory regime for commercial...

Issue 15, June 28, 2006

• Use caution when defining "gifts," say compliance officers

  Pharmaceutical companies that are trying to keep up with the various state reporting laws should...

• Gift disclosure bill dies in New York Senate

  A New York state bill that would have required pharmaceutical companies to disclose their gifts to...

• House committee report shows decline in FDA warning letters

  The number of warning letters from the FDA has dropped more than 50% over the last five years...

• FDA: GSK makes misleading claims on Web site, other materials

  GlaxoSmithKline makes promotional claims about its treatment for initial genital herpes that...

Issue 14, June 21, 2006

• Louisiana bills lighten sample requirement, tighten lobbying

  New legislation in Louisiana may allow sales reps to give drug samples without violating the state...

• Baxter Healthcare Corp. agrees to pay $8.5 million to settle Medicaid fraud suit

  Texas State Attorney General Greg Abbott won an $8.5 million settlement last week from Baxter...

Issue 13, June 14, 2006

• Solvay, TAP to extend patient assistance to Part D eligibles

  Solvay Pharmaceuticals said last week that it would extend eligibility for its patient assistance...

Issue 12, June 7, 2006

• Massachusetts Senate passes drug rep licensing proposal

  The Massachusetts State Senate passed a proposal last week that would require drug reps to be...

• DDMAC: Boehringer Ingelheim promotion misbrands drug

  DDMAC is calling on Boehringer Ingelheim to immediately stop disseminating a four-page promotional...

• OIG: Requirements for determining AMPs unclear

  The OIG recently studied the requirements for how manufacturers determine average manufacturer...

Issue 1, November 29, 2006

• Fiscal 2006 was a record year for fraud and false claims recovery, DOJ reports

  The United States government recovered over $3.1 billion in fraud settlements and judgments in...