Pharmaceutical company QOL Medical and its CEO Frederick Cooper have agreed to pay $47 million to settle allegations they offered kickbacks to promote claims for a QOL drug.
QOL allegedly provided free Carbon-13 breath testing services as kickbacks to encourage claims for Sucraid, an FDA-approved treatment for congenital sucrase-isomaltase deficiency, a rare genetic condition, according to a Nov. 15 Justice Department news release.
Starting in 2018, QOL, with Mr. Cooper's approval, distributed free Carbon-13 breath test kits to healthcare providers, encouraging them to offer the kits to patients with common gastrointestinal symptoms.
The company claimed the test could "rule in or rule out" CSID, but the test cannot specifically diagnose the condition, as other factors can cause low sucrase activity. According to the release, about 30% of the Carbon-13 breath tests from QOL were positive for low sucrase activity.
Between 2018 and 2022, QOL used patient data from Carbon-13 breath tests, provided by a laboratory without patient names, to target healthcare providers whose patients tested positive for CSID.
Additionally, QOL sales representatives were instructed to promote Sucraid to these providers and track whether the tests led to prescriptions, and some made unsupported claims about the test's accuracy, according to the release.