FDA Fraud
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Is The FDA Ready For Kim Kardashian And Mutant Head Lice?
Posted 08/31/15
(published on the Huffington Post blog)
A pharmaceutical company was recently reprimanded by the FDA for its misleading marketing tactics on an unexpected forum—Kim Kardashian's Instagram feed. The new mother's failure to address the full safety profile of morning sickness drug, Diclegis, prompted the FDA to issue a warning letter to the drug's manufacturer. This sort of enforcement is representative of the...
Is the FDA Ready for Kim Kardashian and Mutant Head Lice?
Posted 08/28/15
Huffington Post (August 28, 2015). Click here to read the article.
Does the FDA Hide Evidence of Clinical Fraud?
Posted 02/13/15
By Marlene Koury
The FDA protects the public health and assures all drugs are proven safe and effective by reputable scientific trials before they are licensed for sale. Or do they? An investigative reporting class at NYU found evidence showing when the FDA finds scientific fraud or misconduct, it does not notify the public, doctors, or the scientific community. Rather, the FDA "has shown a pattern of burying...
DOJ Catch of the Week – Vascular Solutions
Posted 08/1/14
By the C|C Whistleblower Lawyer Team
This week's Department of Justice "catch of the week" goes to Vascular Solutions Inc (VSI). On Monday, the Minneapolis-based medical device maker agreed to pay $520,000 to resolve allegations that it violated the False Claims Act by marketing a product for sealing veins without FDA approval. Specifically, the government charged that VSI marketed and sold its "Vari-Lase...
July 28, 2014
Vascular Solutions Inc (VSI), a Minneapolis-based medical device maker, agreed to pay $520,000 to resolve allegations that it violated the False Claims Act by marketing a product for sealing veins without FDA approval. Specifically, the government charged that VSI marketed and sold its "Vari-Lase Short Kit" for treating perforator veins (which run deep in the leg muscle) even though the FDA approved the device only for treating surface (or superficial) veins. DeSalle Bui, a former sales representative of VSI, will receive a whistleblower award in an undisclosed amount. DOJAnother Bad Report Card for the Beleaguered FDA
Posted 11/29/12
By Gordon Schnell
The Food and Drug Administration (FDA) admittedly has a lot on its plate. Tasked with regulating the country’s food and medicine supply, not to mention the ever-evolving array of medical devices and procedures, the FDA is the federal agency perhaps most responsible for ensuring our health and well-being. If the agency does not perform up to task, a lot of people are affected. So it is no...
FDAGate -- The Latest Lapse in Government Enforcement
Posted 07/20/12
By Gordon Schnell
In what quickly has become the most recent "gate" scandal in Washington, the evidence continues to mount that the FDA acted to stifle whistleblowers within its own ranks. It all began several years ago when a half-dozen FDA scientists and doctors objected to certain imaging devices for mammograms and colonoscopies because of the high levels of radiation they believed the equipment emitted. The...