WASHINGTON – Massachusetts-based DUSA Pharmaceuticals Inc. (DUSA), a subsidiary of Sun Pharmaceutical Industries Inc. (Sun Pharma), is shelling out $20.75 million to settle allegations of a brazen scheme to bilk Medicare and the Federal Employee Health Benefit Program (FEHBP). The feds say DUSA knowingly pushed a faulty administration process for their drug, Levulan Kerastick, ignoring FDA guidelines and clinical evidence – all to pad their profits.
The Justice Department isn’t playing around. Acting Assistant Attorney General Ethan P. Davis for the Civil Division stated plainly, “The department is committed to protecting taxpayer-supported health care programs from fraud and abuse. We will hold drug manufacturers accountable when they knowingly promote ineffective uses of their products that undermine patient care or waste program funds.” This isn’t just about money; it’s about a company prioritizing the bottom line over patient well-being.
U.S. Attorney Brian T. Moran for the Western District of Washington laid it even more bare: “This scheme to provide false instructions on the use of its product may have resulted in more sales and bigger profits, it also meant customers endured the frustration of being repeatedly subjected to less effective treatments to try to get their skin lesions to clear.” Investigators allege that between January 2014 and December 2016, DUSA actively encouraged doctors to use a significantly less effective, short-incubation method for Levulan Kerastick, despite knowing it drastically lowered success rates.
Levulan Kerastick is approved for treating actinic keratosis (AKs), pre-cancerous skin lesions. The FDA-approved method requires a 14-18 hour incubation period followed by blue light treatment. But DUSA allegedly pushed for 1-3 hour incubations, utilizing paid physician speaker programs, peer-to-peer discussions, and their sales force to spread the word. Worse, the department claims DUSA either failed to disclose the lower success rates of the shorter method or, in some cases, *falsely* claimed the results were the same. “Drug makers that push the inappropriate use of their products undermine the health of patients and the financial integrity of federal health care programs,” stated Steven J. Ryan, Special Agent in Charge of the U.S. Department of Health and Human Services Office of Inspector General.
The Office of Personnel Management (OPM) is also weighing in, with Deputy Inspector General Norbert E. Vint emphasizing, “The OPM OIG will always seek to hold accountable those prioritizing profits over patient health and safety.” The feds say senior management at both DUSA and Sun Pharma were aware of the issue as early as January 2014. This wasn’t a rogue employee; it was a calculated decision at the highest levels of the company.
As part of the settlement, DUSA and its parent company, Sun Pharma, have agreed to abide by strict measures to ensure future compliance. But the $20.75 million payout is a clear message: cutting corners with patient health and defrauding federal programs comes with a hefty price. Grimy Times will continue to follow this case and expose those who put profits before people.
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Key Facts
- State: Washington
- Agency: DOJ USAO
- Category: White Collar Crime
- Source: Official Source ↗
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