Fresenius in Hot Water with FDA for Poor Communication
Source Consider this scenario: A company runs the largest chain of dialysis centers in the US and is also the leading supplier of products that are used not only by its own clinics, but my many rivals. In 2010, the company discovers a potentially lethal risk is associated with one widely used product. Last fall, […]
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British Pharma Association Admonishes Two Firms for Christmas Party
source So when is an educational symposium in fact a Christmas party? And the answer to the riddle is… when the meeting is held in a restaurant 10 days before Christmas, the invitation mentions ‘Xmas meal,’ the program lasts approximately one hour and the open-ended gathering is initiated by a physician who regularly meets with […]
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Supreme Court Rules: Pharma Reps Not Entitled to Overtime
Source In a widely anticipated ruling, the US Supreme Court decided in a 5-to-4 vote that pharmaceutical sales reps are not entitled to overtime pay, an issue that plagued drugmakers as they attempt to cut costs and redefine the role played by sales teams. And in finding in favor of the industry, the court also […]
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Is FDA The Cause of Recent Drug Shortages?
Source As the cliche goes – damned if you do, damned if you don’t. As the ongoing crisis over shortages of prescription drugs persists, a new report from the US House Committee on Oversight and Government Reform finds that a key culprit all along has been… the FDA. Instead of ensuring that the nation has […]
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Dialysis Company’s Failure to Warn of Product Risk Draws Inquiry
The Food and Drug Administration is investigating whether the nation’s largest operator of dialysis centers violated federal regulations by failing to inform customers of a potentially lethal risk connected to one of its products, an F.D.A. official said. The company, Fresenius Medical Care, treats more than a third of the estimated 400,000 Americans receiving dialysis. […]
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FDA rebukes Advocate Health Care
The U.S. Food and Drug Administration has sharply criticized Advocate Health Care, the state’s largest health system, for enrolling emergency room patients in a clinical trial without their permission. In a warning letter made public this week, the FDA questioned a study designed to evaluate the effectiveness of a sedative called etomidate. The subjects were […]
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IRB Fails to Get Informed Consent
source One of the largest health systems in the US may have a little trouble connecting the dots. Specifically, the Advocate Health Care institutional review board was conducting a clinical trial of an intravenous anesthetic, but failed to ensure that informed consent was sought from participants. Why? Initially, the IRB was running a chart review […]
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Congress Mulls Fining Drug Firms for Not Reporting Shortages
source As the US Senate and House prepare to reconcile their differing versions of the Food and Drug Administration Safety and Innovation Act, which most people still refer to as PDUFA, a coalition of 20 organizations representing physicians, hospitals, and patient advocacy groups appears to have given up on the possibility that drugmakers will be […]
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Lundbeck to cut 600 jobs in Europe to contain costs
Danish drugmaker Lundbeck said on Thursday it would cut around 600 jobs in its commercial organisation in Europe to reduce costs and would book restructuring charges of up to 500 million Danish crowns ($84.60 million) as a consequence. Lundbeck said in a statement the action would be taken to mitigate increased pressure from healthcare reforms, […]
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Allergan Board Facing Lawsuit by Shareholders
Two years after Allergan agreed to pay $600 million to settle charges that Botox was marketed for various unapproved uses, a federal judge has given a green light to a lawsuit claiming the Allergan board should be held responsible instead of relying on the corporate treasury. The off-label marketing involved promoting Botox to treat headaches, […]
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