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What’s New/Significant
DUSA Pharmaceuticals, Inc. (DUSA), a subsidiary of Sun Pharmaceutical Industries, Inc. (Sun Pharma), agreed to pay the United States $20.75 million to resolve allegations that it caused physicians to submit false claims to Medicare and the Federal Employee Health Benefit Program by knowingly promoting an off-label administration process for its Levulan Kerastick drug that contradicted the product instructions approved by the U.S. Food and Drug Administration (FDA) and was unsupported by sufficient clinical evidence.
The settlement with DUSA originated with a lawsuit filed by a former DUSA sales representative under the whistleblower provision of the False Claims Act, alleging false claims and seeking a share of the government’s recovery. As part of the resolution, the former sales representative will receive approximately $3.5 million.
Allegations
Levulan Kerastick is a prescription topical solution approved for the treatment of minimally to moderately thick actinic keratosis (AK) of the face or scalp. The “Dosage and Administration” section of the drug’s FDA-approved instructions described a two-stage process involving application of the topical solution to target lesions and then, following an incubation period of 14 to 18 hours, illumination of the target lesions with blue light.
The government alleged that between January 2014 and December 2016, DUSA encouraged physicians to use off-label, shorter incubation periods (ranging from one to three hours), rather than the FDA-approved 14- to 18-hour incubation period. DUSA also encouraged physicians to use Levulan Kerastick on nonapproved body parts. According to the government, DUSA knowingly promoted the shorter incubation period through paid physician speaker programs, paid physician peer-to-peer discussions, promotion by DUSA’s sales force, and the dissemination of incomplete or misleading responses to questions from prescribing doctors.
The government further alleged that DUSA (i) failed to inform physicians that administering the drug using short incubation periods resulted in significantly lower AK clearance rates than achieved with the longer incubation period, and (ii) in some instances, falsely stated that AK clearance rates were the same for the shorter and less effective incubation periods. DUSA’s off-label promotion of its drug resulted in the submission of false claims to government health care programs in violation of the False Claims Act.
Scope of Settlement
In addition to the settlement, DUSA and its parent company, Sun Pharma, agreed to enter into a Corporate Integrity Agreement with the U.S. Department of Helth and Human Services Office of the Inspector General (HHS-OIG) that requires the implementation of procedures and reviews to avoid and promptly detect conduct similar to that which gave rise to this matter.