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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 19, May 13, 2009
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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...