QOL Medical, LLC, and its CEO Frederick E. Cooper have agreed to a $4.7 million settlement with the Department of Justice (DOJ). The settlement resolves allegations that the company provided kickbacks to healthcare providers to induce prescriptions of their drug, Sucraid. This drug is FDA-approved for Congenital Sucrase-Isomaltase Deficiency (CSID), a rare genetic condition that hampers the digestion of sugar.
The allegations against QOL Medical highlight a new practice within the pharmaceutical industry sector: offering free diagnostic tests as incentives for prescribing specific medications. According to the DOJ, QOL provided complimentary Carbon-13 (C13) breath testing kits to healthcare providers. These kits were intended for patients exhibiting common gastrointestinal symptoms, ostensibly to diagnose CSID. However, the DOJ claimed that the test was also sensitive to other conditions that could yield similar test results, suggesting that the tests were not as definitive as QOL portrayed.
QOL’s approach to marketing Sucraid was also under scrutiny. The company allegedly paid a laboratory to conduct the tests and share the results, not only with the ordering healthcare providers but also with QOL. This information included the provider’s name and details about the patient’s age, gender, symptoms, and test outcomes—data that was then reportedly used by QOL’s sales team to target their pitches effectively.
The sales tactics employed by QOL were particularly aggressive....
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