DUSA Pharmaceuticals allegedly encouraged physicians to use the less effective short incubation periods by using paid physician speaker programs and paid physician peer-to-peer discussions, disseminating incomplete or misleading responses to questions from prescribing doctors, among other tactics.
Additionally, the federal government alleged that DUSA Pharmaceuticals failed to disclose to physicians that the administration of Levulan Kerastick using short incubation resulted in significantly lower AK clearance rates than the FDA-approved longer incubation.
In a statement, DOJ Civil Division Acting Assistant Attorney Ethan Davis said, “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.”
On the other hand, HHS OIG Special Agent in Charge Steven Ryan commented, “Drugmakers that push the inappropriate use of their products undermine the health of patients and the financial integrity of federal health care programs. Our oversight agency, working closely with our law enforcement partners, will continue to thoroughly investigate those who engage in such schemes.”