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Pharma Compliance Alert

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Pharma Compliance Alert

Issue 39, December 19, 2007

• Novartis targeting insurers instead of physicians

  Novartis will start a three-state pilot program in January designed to reorganize its sales force...

• FDA rules Effexor XR journal ad misleading

  The FDA ruled a professional journal ad for Wyeth's Effexor XR misbrands the product because it...

• DC could soon license pharmaceutical sales reps

  The District of Columbia took one more step towards becoming the first jurisdiction to require...

Issue 38, December 12, 2007

• Tired? Need new tools to refresh your compliance program and your career? Tell us about it.

  HCPro Inc. wants to know what we can do to help you wake up your facility's compliance efforts.

• Judge rules Wyeth not negligent in Prempro suit

  A Philadelphia judge overturned a $3 million verdict against Wyeth because the plaintiff did not...

• Merck to set aside $670 million to settle False Claims cases

  The cost to settle False Claims Act cases for Merck-$670 million, according to a release from the...

Issue 37, December 4, 2007

• Tired? Need new tools to refresh your compliance program and your career? Tell us about it.

  HCPro Inc. wants to know what we can do to help you wake up your facility's compliance efforts.

• Medicare beneficiary sues over Part D non-coverage of off-label use

  A 66-year-old widow is suing the Department of Health and Human Services (HHS) because Medicare...

• FDA warns GlaxoSmithKline about Tykerb

  In a warning letter posted last week, the FDA warned GlaxoSmithKline that three Dear Dr. letters...

• FDA may ease restrictions on off-label information

  The FDA may soon make it easier for pharmaceutical and medical device manufacturers to distribute...

Issue 36, September 12, 2007

• Sanofi-Aventis settles drug pricing case

  Sanofi-Aventis paid federal and state governments more than $190 million to settle allegations that...

• Senators say public should know when pharmaceutical makers give money to doctors

  Federal legislation being introduced by Senators Chuck Grassley and Herb Kohl will require...

• Pharma not the only target, officials say

  Editor's note: this is the first in a two-part series reporting on the panel discussion at last...

• No preemption means more rules, more headaches for pharma companies

  The Physician Payments Sunshine Act, introduced by Senators Charles Grassley (R-Iowa) and Herb Kohl...

• Fraud identification moving to analytical contractors

  More than 20 firms are competing for a chance to slice and dice health data to look for improper...

• More light being shed on payments to physicians

  Beginning in January, orthopedic surgeons will have to tell patients about any financial...

• Off-label marketing lawsuits against Schering-Plough consolidated

  Eight putative cases pending in U.S. District Court in New Jersey against Schering-Plough were...

Issue 35, September 5, 2007

• Prescription data firms sue over confidentiality laws

  After successfully challenging a New Hampshire law that banned the sale of prescription...

• Court upholds advertising ban on Xenical in Australia

  The Australian Federal Court upheld a ban on advertising for Roche's weight-loss drug Xenical.

• OIG chief counsel offers tips to pharmaceutical companies

  Editor's note: This is the second in a two-part series on OIG Chief Counsel Lewis Morris' remarks...

• FDA warns Johnson & Johnson about Natrecor mouse pad, pen

  A mouse pad and pen used by Johnson & Johnson are not appropriate reminder labeling for...

• GlaxoSmithKline allegedly tried to intimidate Avandia critic

  GlaxoSmithKline (GSK) allegedly tried to silence Dr. John Buse, an independent scientist who...

Issue 34, August 22, 2007

• Massachusetts AG reaches settlement with drug company on price reporting litigation

  Massachusetts Attorney General Martha Coakley's office has reached a settlement with one of 13...

• FDA warns Novartis about Exelon professional file card

  In a warning letter posted online last week, DDMAC called for Novartis to stop distributing the...

• 3rd Circuit Court rules only FDA can regulate ads

  The 3rd U.S. Circuit Court of Appeals recently upheld the dismissal of a class action lawsuit...

• State advisory board members received money from pharma companies

  An Associated Press review of records in Minnesota founds that two members of the eight-member...

• Pharma companies can benefit from tracking spending

  Individual state laws that require pharmaceutical companies to track all the gifts they give...

• Pharmaceutical companies under intense scrutiny

  Editor's note: This is the first in a two-part series on OIG chief counsel Lewis Morris' remarks at...

• Merck to settle Vioxx claims for $4.85 billion

  <p>After fighting individual lawsuits over its pain reliever Vioxx for years, Merck has...

Issue 33, August 15, 2007

• OIG: New York, Nevada's false claims acts meet DRA incentive requirements

  The OIG has posted two new state false claims act review letters for New York and Nevada.

• GAO criticizes FDA's inspections of foreign drug makers

  The FDA can only identify inspection records for one-third of foreign pharmaceutical manufacturers...

• AstraZeneca and Bristol-Myers Squib to pay $13.6 million

  AstraZeneca and Bristol-Myers Squib have been ordered to pay a combined $13.6 million for allegedly...

• FDA asks Pfizer to pull misleading journal ad

  A journal ad for Pfizer's Geodon for Injection contained unsubstantiated superiority claims and...

Issue 32, August 8, 2007

• ACCME to examine current commercial support standards

  The Accreditation Council for Continuing Medical Education (ACCME) plans to examine how well it...

• Presidential candidate wants drug makers to wait two years before advertising

  Presidential hopeful John Edwards believes drug manufacturers should have to wait two years before...

• FDA warns Aventis Pharmaceuticals about clinical trial

  The FDA issued a warning letter to Aventis Pharmaceuticals regarding its role as the sponsor of a...

• DOJ alleges whistleblower part of fraud scheme

  The man who blew the whistle on Cell Therapeutics is now under investigation by the Department of...

• Grassley to propose national physician payment disclosure registry

  Senior Senate Finance Committee member Charles E. Grassley says he will propose legislation to form...

Issue 31, August 1, 2007

• Detail aid misbrands dermatology drug, says DDMAC

  A detail aid and journal ad for Doak Dermatologics' product Solaraze Gel recommends or suggests...

• Oklahoma False Claims Act goes into effect November 1

  Oklahoma will join the 18 states and the District of Columbia with their own version of the federal...

• Study finds strong ties between pharmaceutical manufacturers, medical schools

  The chairs of more than half of the medical schools and teaching hospitals in the U.S. have ties to...

• Pharma access to Rx-ing info on agenda for NCSL annual meeting

  The issue of pharmaceutical access to prescription records identifying doctors or patients for...

• Correction: Purdue Pharma

  Correction: Last week we incorrectly reported that three Purdue Pharma executives were charged with...

Issue 30, July 25, 2007

• Aussie pharmas must publicly disclose gifts to docs online

  Australian pharma companies that manufacture and market prescriptions will have to report the type...

• Other states consider copying Minnesota's limits on physician gifts

  Two years after Minnesota officials limited drug makers to giving physicians $50 or less in gifts a...

• Iowa AG suing 78 pharmaceutical companies

  Iowa Attorney General Tom Miller is suing 78 pharmaceutical companies for allegedly inflating drug...

• OIG issues report on CMS safeguards to prevent and detect fraud

  In fiscal year 2006, CMS relied mainly on complaints from beneficiaries, pharmacists, and plan...

• Purdue Pharma to pay $634M, charged with felony over OxyContin

  Purdue Pharma will pay $634 million to settle an investigation about OxyContin marketing, according...

Issue 29, July 18, 2007

• Nevada pharma marketing law may be all bark and no bite

  The state of Nevada has passed a pharma marketing law that seems to be a weaker version of...

• OIG releases report on FDA's oversight of clinical trials

  The FDA's ability to oversee clinical trial inspections is hindered by weakness in its information...

• OIG reports on ASP and AWP

  The Office of Inspector General (OIG) released its review of average sales price (ASP) and average...

• Bush signs drug safety bill

  On September 27, President Bush signed new legislation giving the FDA more power to police...

• OIG releases 2008 Work Plan

  The OIG's recently-released 2008 Work Plan addresses a variety of topics related to Medicare Part D...

• Eli Lilly receives warning about Cymbalta

  In a warning letter posted last week, the FDA informed Eli Lilly that its professional mailer for...

• Jazz to pay $20M as subsidiary pleads guilty to misbranding drug

  Jazz Pharmaceuticals will pay $20 million in civil and criminal payments as part of a settlement...

Issue 28, July 11, 2007

• China executes ex-drug official for taking bribes

  China executed this week the former head of its food and drug administration after he was convicted...

• Bristol-Meyers Squibb to pay $515 million for illegal drug marketing

  Bristol-Myers Squibb Company (BMS) and its wholly owned subsidiary, Apothecon, Inc., will pay more...

• FDA warning letter calls Lilly ads, articles for dog drug misleading

  Eli Lilly's ad and other materials promoting Prozac for dogs are misleading, says an FDA warning...

Issue 27, July 4, 2007

• VT's pharma disclosure report: Psychiatrists receive most payments

  Pharmaceutical companies spent $2.25 million in marketing expenses in Vermont during fiscal year...

• Congress OKs FDA safety bill

  Congress is giving the FDA more power to police prescription drugs already on the market as part of...

• Pharma companies aren't the only targets of law enforcement

  Editor's note: This is the second in a two-part series reporting on the panel discussion at the...

• Senate hearing examines drug industry ties with doctors

  During a hearing last week, Senate Special Committee on Aging Chairman Herb Kohl said he would...

Issue 26, June 27, 2007

• Texas AG sues three pharmas, alleging Medicaid fruad

  Texas Attorney General Greg Abbott last week charged Mylan Laboratories, Sandoz, and Teva...

• N.Y. AG files suit against Merck for hiding Vioxx risks

  Attorney General Andrew M. Cuomo and New York City Mayor Michael Bloomberg filed a joint lawsuit...

• Judge rules against three pharmas in AWP case

  A judge last week ruled against AstraZeneca, Schering-Plough, and Bristol-Myers Squibb in an...

Issue 25, June 20, 2007

• House committee seeks FDA communications from J&J, Amgen

  The probes into anemia treatments continue, this time with the U.S. House Energy and Commerce...

• AARP lobbies for NY gift disclosure legislation

  AARP and other groups are lobbying for the New York State legislature to pass gift disclosure...

Issue 24, June 13, 2007

• Jazz, subsidiary discuss settlement with U.S. Attorney

  Jazz Pharmaceuticals, along with its subsidiary Orphan Medical, is discussing a possible settlement...

• Study: Positive clinical trial results often correlate with pharma funding

  A new study shows that in head-to-head clinical trials of drugs, drug-company funding appears to...

Issue 23, June 6, 2007

• J&J latest target of Grassley probe into ESA pricing, marketing

  Ranking Senate Finance Committee Member Chuck Grassley (R-IA) is continuing his probe into the...

• Doc who said GSK tried to silence him will testify during Avandia hearing

  When a congressional committee digs into the safety of GlaxoSmithKline's diabetes drug Avandia this...

Issue 22, May 30, 2007

• Amgen gets subpoena from NY AG

  Amgen received a subpoena from New York's attorney general, it said last week in a Securities and...

• Special report: Hospitals and rep credentialing programs

  Across the country, vendor access, or "credentialing," programs are restricting healthcare industry...

Issue 21, May 23, 2007

• Utah sues Lilly over Zyprexa marketing

  Utah became the latest state to sue Eli Lilly for allegedly misrepresenting the risks of the...

• USA Today: Senators with industry ties limited FDA powers

  Pharmaceutical muckraking has hit USA Today, with the paper reporting that senators who helped...

Issue 20, May 16, 2007

• NYT digs into drug makers' payments to psychiatrists in MN

  Aside from the logistical difficulties that come with state marketing laws, a recent New York Times...

• Purdue, execs plead guilty to misbranding OxyContin, agree to $634.5M fine

  Purdue Pharma and its president, chief legal officer, and former chief medical officer pleaded...

Issue 19, May 9, 2007

• OIG: States concerned about validity of AMP data

  Although CMS has been sending states monthly average manufacturer price (AMP) data since July, most...

• NH ban on sale of prescribing data shot down in federal court

  States considering legislation to bar the sale of prescribing information may hit some...

• Serono execs acquitted

  A federal jury in Boston acquitted four former Serono executives of charges that they offered...

Issue 18, May 2, 2007

• Delaware AG probes pharma-hospital pricing contracts

  Delaware Attorney General Beau Biden is quietly investigating several pharmaceutical...

• Georgia and New York latest states with False Claims Acts

  Georgia and New York have each passed state-specific versions of the False Claims Act, bringing the...

Issue 17, April 25, 2007

• Republicans stand up to drug-safety bill requirement for prohibiting DTC ads

  The Senate Health, Education, Labor and Pensions panel passed legislation Wednesday that...

• Dey pays $2.9M to settle price-reporting litigation

  California-based Dey, Inc., has paid $2.9 million to Massachusetts to settle alleged inflated...

Issue 16, April 18, 2007

• Judge in NH Rx datamining case asks for factual review

  A federal judge asked lawyers from both sides of the New Hampshire prescription data mining case to...

• OIG: Proposed PAP carries little fraud risk

  A pharmaceutical company's proposed patient assistance program (PAP) will have little potential for...

• AZ opens investigation into

  Enter the words "Group of 7" and AstraZeneca into a search engine and the search will yield a host...

Issue 15, April 11, 2007

• Grassley requests Zypreza marketing docs from Lilly

  Eli Lilly has only two weeks to deliver Zyprexa marketing documents to the Senate Finance Committee.

• Former Chinese drug regulator faces charges of taking kickbacks for approvals

  A former Chinese drug regulator is about to go on trial on charges that he took kickbacks from drug...

Issue 14, April 4, 2007

• Pfizer to pay $34 million settle charges of improper marketing

  Pfizer will pay $34.7 million to settle separate allegations of off-label marketing and improper...

• At least 27 proposed state laws to regulate Rx marketing, ads

  So far this year, at least 27 states have proposed legislation requiring marketing disclosures...

Issue 13, March 28, 2007

• Drug, device ties capped at $50K for docs on FDA ad boards

  The FDA has proposed stricter conflict of interest rules that set a grant or fee cap of $50,000 for...

• PhRMA: JAMA article on payments to docs mixes apples and oranges

  Last week's article in the Journal of the American Medical Association (JAMA) examining the process...

• In brief: Possible DTC ban: House bill says three years, Senate says two

  Last week, the House introduced a bill that would implement a three-year ban on DTC ads for new...

Issue 12, March 21, 2007

• Montana complaint against Lilly alleges off-label Zyprexa marketing

  Last week, Montana became the seventh state to sue Eli Lilly over its alleged off-label marketing...

• Pfizer gets reprimanded by UK agency for journal ad

  Pfizer got a slap on the wrist earlier this month when the United Kingdom's Medicines and...

Issue 11, March 14, 2007

• OIG to combine "Red" and "Orange" books

  The OIG is in the process of combining its "Red Book" and "Orange Book" into one publication...

• Takeda gets FDA warning for

  A 10-second TV ad for Rozerem is "concerning" because it suggests that the sleep aid is safe for...

• J&J receives three subpoenas regarding subsidiary oversight

  Johnson & Johnson (J&J) has received three separate subpoenas from three U.S. Attorney’s...

Issue 10, March 7, 2007

• Waxman requests marketing info from Lilly, AstraZeneca, others

  Safety concerns and allegations of inappropriate marketing are the focus of letters that...

• PA sues Lilly, AZ, Janssen claiming deceptive marketing

  The Commonwealth of Pennsylvania has sued Eli Lilly, AstraZeneca, and Janssen, alleging deceptive...