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Pharma Compliance Alert

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Pharma Compliance Alert

Issue 19, May 13, 2009

• Editor's Note: Final Issue of Pharma Compliance Alert

  This will be the final issue of Pharma Compliance Alert. We thank you for being a loyal subscriber.

• Vermont strengthens gift ban

  The Vermont legislature is getting tougher on the pharmaceutical industry by passing a bill that...

• No class action status in CA Vioxx lawsuit

  Los Angeles Superior Court Judge Victoria G. Chaney denied class action status to plaintiffs...

Issue 18, May 6, 2009

• Editor's Note: Publication of Pharma Compliance Alert to end May 13

  Next week’s issue will be the final issue of Pharma Compliance Alert. We thank you for being...

• Ranbaxy recalls Nitrofurantoin

  Ranbaxy Laboratories issued a voluntary recall for all 100 mg Nitrofurantoin Capsules currently on...

• Michigan False Claims Act qualifies for additional recoveries

  Michigan’s Medicaid False Claims Act meets the requirements of the Deficit Reduction Act of...

• IOM calls for end to industry support

  The Institute of Medicine (IOM) became the latest organization to call for an end to pharmaceutical...

Issue 17, April 29, 2009

• Court upholds Vermont ban on data mining

  Pharmaceutical companies may soon be unable to collect prescriber data in Vermont.

• PhRMA revises guidelines for clinical trials

  Pharmaceutical companies should provide results summaries for all interventional clinical trials...

Issue 16, April 22, 2009

• Pharma companies spent almost $3M on marketing in Vermont for FY 2008

  Pharmaceutical manufacturers paid almost $3 million to 2,280 doctors, hospitals, universities, and...

• Genentech withdraws Raptiva

  Genentech is voluntarily withdrawing its psoriasis drug Raptiva from the U.S. market because of the...

• AndroGel manufacturers accussed of delaying generics

  Unimed Pharmaceuticals, Solvay Pharmaceuticals, Watson Pharmaceuticals, Par Pharmaceuticals, and...

• Business associates: HIPAA survey

  We want to hear from business associates about their need for HIPAA training. Business associates...

Issue 15, April 15, 2009

• Pharma companies barred from manufacturing unapproved drugs

  The FDA barred Neilgen Pharmaceuticals and its parent company, Advent Pharmaceuticals from...

• Healthcare institutions limit access by pharmaceutical companies

  Johns Hopkins Medicine (JHM) and Partners HealthCare are enacting new conflict-of-interest policies...

Issue 14, April 8, 2009

• FDA warns pharma companies for online ads

  Fourteen pharmaceutical companies received warning letters from the FDA for...

• Former BMS exec pleads guilty to false FTC certification

  Andrew Bodnar, a former senior executive with Bristol-Myers Squibb (BMS), pleaded guilty April 6...

• Caraco recalls Digoxin tablets

  Caraco Laboratories issued a recall for its Digoxin tablets because they may differ in size and...

• Start preparing now for disclosures in Massachusetts

  Beginning July 1, every pharmaceutical company must annually disclose to the Massachusetts...

Issue 13, April 1, 2009

• BMS settles Plavix investigation

  Bristol-Myers Squibb (BMS) will pay $2.1 million to resolve allegations it made false statements to...

• Former Pfizer sales manager pleads guilty to misbranding

  Mary Holloway, 47, of Branchburg, NJ, pleaded guilty to violating the Food, Drug, and Cosmetic Act...

• Complying with Massachusetts disclosure regulation will be a challenge

  Massachusetts’ new disclosure regulation, which goes into effect July 1, presents some unique...

• GSK announces plans to increase transparency of clinical research

  GlaxoSmithKline (GSK) will disclose payments to U.S. healthcare professionals and their...

• Psychiatric association to stop accepting industry support for symposia

  An increased focus on transparency means an end to pharmaceutical industry support for American...

Issue 12, March 25, 2009

• Merck updates grand jury investigation

  A grand jury is investigating Merck’s research, marketing, and selling activities for its...

• Iowa Senate passes gift ban

  The Iowa Senate is following Massachusetts’ example by passing strict legislation regulating...

• Antitrust suit against GSK, Bioval to continue

  GlaxoSmithKline (GSK) will have to defend itself against a lawsuit claiming the company prevented...

• Watson recalls Propafenone HCL tablets

  Watson Pharmaceuticals is voluntarily recalling one lot of Propafenone HCL 225 mg tablets sold in...

Issue 11, March 18, 2009

• Massachusetts disclosure regulations most strict in the country

  Massachusetts set a new bar for pharmaceutical and medical device manufacturers disclosure...

• Antidepressant lawsuits against GSK, Pfizer back on

  Pharmaceutical companies are already seeing the fallout from the Supreme Court’s decision...

• FDA warns Genzyme for GMP violations

  Genzyme’s Allston, MA, facility significantly deviated from current Good Manufacturing...

• FDA: Gilead rep made misleading statements

  A Gilead Sciences representative made false or misleading statements about the company’s...

Issue 10, March 5, 2009

• Supreme Court rules against Wyeth in preemption case

  The US Supreme Court ruled 6-3 that FDA approval does not shield pharmaceutical companies from...

• Former sales rep alleges J&J, Janssen pushed off-label promotion

  Johnson & Johnson and its subsidiary Janssen Pharmaceutica directed sales representatives to...

• Judge rules J&J and Janssen misled physicians

  Johnson & Johnson and its Janssen Pharmaceuticals unit must pay West Virginia roughly $4.5...

• Grassley asks for details of Pfizer payments to physicians

  Senator Charles Grassley (R-IA) continues to investigate financial ties between pharmaceutical...

• GSK warned about misleading TV ad

  A direct-to-consumer television ad misbrands GlaxoSmithKline’s prostate drug Advodart...

Issue 9, March 4, 2009

• Amgen, Wyeth sued for alleged illegal marketing

  A whistleblower lawsuit partially unsealed in Massachusetts accuses Amgen of engaging in illegally...

• DOJ sues Forest for False Claims Act violations

  Forest Laboratories allegedly improperly marketed its antidepressants Celexa and Lexapro for...

• KV Pharmaceutical enters into consent decree with FDA

  KV Pharmaceutical may soon resume manufacturing and marketing products after entering into a...

• FDA levels new allegations against Ranbaxy plant

  Ranbaxy Laboratories’ Paonta Sahib, India, facility falsified data and test results in...

• No disclosure bill in NM

  The New Mexico Senate rejected a bill requiring pharmaceutical manufacturers to report gifts to...

• Alabama jury convicts Sandoz of pricing fraud

  Alabama Attorney General Troy King is now 3-for-3 in jury trials against pharmaceutical companies...

Issue 8, February 25, 2009

• Justice Department joins suits against J&J

  The Department of Justice (DOJ) joined two whistleblower lawsuits filed against Johnson &...

• Colorado Senate kills ethics bill

  Colorado’s Prescription Drug Ethics Act died after a 6-1 vote against it by a state senate...

• Pfizer fined $9M for alleged fraud in Wisconsin

  A jury found Pfizer’s Pharmacia unit guilty of fraud for overcharging Wisconsin’s state...

• Physicians approve of pharma-sponsored CME

  Physicians overwhelmingly support pharmaceutical industry sponsorship of continuing medical...

Issue 7, February 18, 2009

• Taro plant doesn't meet GMP requirements, FDA says

  FDA inspectors found significant deviations from current Good Manufacturing Practices (cGMP) at...

• California Supreme Court declines to hear Wyeth case

  A California appeals court decision stays since the state’s Supreme Court declined to review...

• Government to continue fraud crackdown

  Pharmaceutical companies can expect to see more state resources aimed at healthcare fraud...

• Survey: PhRMA Code changes showing mixed results

  Updates to the PhRMA Code on Interactions with Healthcare Professional are not significantly...

Issue 6, February 11, 2009

• Pfizer to disclose payments to physicians

  Pfizer will become the first pharmaceutical company to disclose payments to physicians for clinical...

• Compliance 'critically important to industry'

  Pharmaceutical manufacturers must make sure compliance and ethics are fully integrated into their...

• States, Bayer settle case alleging deceptive advertising

  Bayer entered into a settlement with 27 states to resolve allegations it deceptively marketed its...

• FDA's final guidance clarifies reprint guidelines

  In January, the FDA provided some much needed guidance for the pharmaceutical industry about when...

• Groups push for gift ban in New York

  A coalition of consumer groups, including the AARP, Consumers Union, and Center for Medical...

Issue 5, January 28, 2009

• New federal disclosure law reduces reporting threshold

  Senators Charles Grassley (R-IA) and Herb Kohl (D-WI) continue to push for national legislation...

• Pharmaceutical companies should make grant process transparent

  In theory, creating a grant strategy is easy, but not in practice, said Belinda Hunt, PhD...

• Minnesota health system to disclosure industry ties to physicians

  Another health system will publicly disclose payments made to its physicians by the pharmaceutical...

• Pfizer Bextra settlement could top $2B

  A $2.3 billion estimated settlement could eclipse Eli Lilly?s $1.4 billion payment to resolve...

• Free White Paper available: Current guidelines for CME funding

  Pharmaceutical, biotech, and medical device industry support for continuing medical education (CME...

• GSK sets aside $400M for possible settlement

  GlaxoSmithKline (GSK) is preparing to settle an ongoing investigation into the company’s...

• FDA warns Abbott for misleading promotion

  Abbott Laboratories’ flashcard for Depakote and Depakote ER misbrands the drugs, according to...

• Sanctura journal ad misleading, FDA says

  A professional journal advertisement for Sanctura, co-promoted by Allergan and Indevus...

Issue 3, January 21, 2009

• E-mails allegedly show GSK concerns about Avandia

  E-mails between GlaxoSmithKline (GSK) researchers allegedly show they were concerned about the...

• Lilly to pay $1.4B for alleged off-label promotion

  Eli Lilly’s tab for allegedly promoting its antipsychotic Zyprexa for off-label uses topped...

Issue 2, January 14, 2009

• FDA finalizes guidance on reprints

  Pharmaceutical and medical device manufacturers will find it easier to distribute journal articles...

• Texas considers disclosure law

  Texas may join a handful of states that require pharmaceutical companies to disclose payments to...

Issue 1, January 7, 2009

• Teva settles false claims allegations in Massachusetts

  Teva Pharmaceuticals paid $7 million to settle allegations it defrauded the Massachusetts Medicaid...

• Industry ties to physicians remain under scrutiny

  Prominent child psychologist Joseph Biederman, MD, will stop participating in industry-sponsored...