Sun Pharma unit reaches $21M settlement over acne drug false treatment claims

A Sun Pharma unit on Aug. 24 agreed to pay $20.75 million to settle allegations of giving physicians misleading treatment instructions for its acne treatment Levulan Kerastick, causing insurers and federal healthcare programs to overpay for the drug, according to the U.S. Department of Justice.

Dusa Pharmaceuticals, which was acquired by Sun Pharma in 2012, allegedly told physicians Levulan Kerastick, an acne ointment applied along with an illuminated blue light, needed a one- to three-hour incubation period to be effective. However, clinical trials identified an effective incubation period to be within the 14- to 18-hour range.

The DOJ alleged Dusa did not inform physicians that shorter incubation periods would mean lower acne clearance rates and sometimes stated the rates were the same regardless of incubation period length. These instances of misinformation happened between January 2014 and December 2016, according to the DOJ.

"While 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 reportedly subjected to less effective treatments to try get their skin lesions to clear," U.S. Attorney Brian Moran said in a statement.

A spokesperson for Sun Pharma told STAT Dusa "fully cooperated with the Justice Department [in] its investigation, and we are happy to have reached a resolution."

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