An oicial website of the United States government
`Here’s how you know
`
`JUSTICE NEWS
`
`Department of Justice
`
`Office of Public Affairs
`
`FOR IMMEDIATE RELEASE
`
`Monday, August 24, 2020
`
`DUSA Pharmaceuticals To Pay U.S. $20.75 Million To Settle False Claims Act
`Allegations Relating To Promotion Of Unsupported Drug Administration Process
`
`Massachusetts-based DUSA Pharmaceuticals, Inc. (DUSA), a subsidiary of Sun Pharmaceutical Industries, Inc. (Sun
`Pharma), has agreed to pay the United States $20.75 million to resolve allegations that DUSA caused physicians to
`submit false claims to Medicare and the Federal Employee Health Benefit Program by knowingly promoting an
`administration process for the drug Levulan Kerastick that contradicted the product instructions approved by the U.S.
`Food and Drug Administration (FDA) and was unsupported by sufficient clinical evidence.
`
`“The department is committed to protecting taxpayer-supported health care programs from fraud and abuse,” said
`Acting Assistant Attorney General Ethan P. Davis for the Justice Department’s Civil Division. “We will hold drug
`manufacturers accountable when they knowingly promote ineffective uses of their products that undermine patient care
`or waste program funds.”
`
`“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 repeatedly subjected to less effective treatments to try
`to get their skin lesions to clear,” said U.S. Attorney Brian T. Moran for the Western District of Washington. “This
`investigation seeks to restore money to taxpayers and discourage those who put profits over effective treatment.”
`
`“Drug makers that push the inappropriate use of their products undermine the health of patients and the financial
`integrity of federal health care programs, said Special Agent in Charge Steven J. Ryan of the U.S. Department of Health
`and Human Services Office of Inspector General. “Our oversight agency, working closely with our law enforcement
`partners, will continue to thoroughly investigate those who engage in such schemes.”
`
`“The OPM OIG will always seek to hold accountable those prioritizing profits over patient health and safety,” said
`Norbert E. Vint, Deputy Inspector General Performing the Duties of the Inspector General, Office of Personnel
`Management (OPM) OIG. “This settlement demonstrates the commitment of our investigative staff and partners at the
`Department of Justice to combat health care fraud against the FEHBP.”
`
`Levulan Kerastick is a prescription topical solution approved by the United States Food and Drug Administration (FDA)
`for the treatment of minimally to moderately thick actinic keratosis (AKs) of the face or scalp. At all relevant times, the
`“Dosage and Administration” section of the drug’s FDA-approved instructions described a two-stage process involving
`application of the topical solution to the target lesions and then, following an incubation period of 14 to 18 hours,
`illumination of the target lesion with blue light.
`
`The United States alleged that, by January 2014, senior management at both DUSA and Sun Pharma knew that
`administration of Levulan Kerastick employing short incubation periods ranging from one to three hours resulted in AK
`clearance rates significantly lower than those achieved in clinical trials using 14 to 18-hour incubation. Nonetheless,
`between January 2014 and December 2016, DUSA allegedly encouraged physicians to use these demonstrably less
`effective short incubation periods by using, among other things, 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
`
`1
`
`

`

`An oicial website of the United States government
`Here’s how you know
`
`JUSTICE NEWS
`
`Department of Justice
`
`Office of Public Affairs
`
`FOR IMMEDIATE RELEASE
`
`Monday, August 24, 2020
`
`DUSA Pharmaceuticals To Pay U.S. $20.75 Million To Settle False Claims Act
`Allegations Relating To Promotion Of Unsupported Drug Administration Process
`
`Massachusetts-based DUSA Pharmaceuticals, Inc. (DUSA), a subsidiary of Sun Pharmaceutical Industries, Inc. (Sun
`Pharma), has agreed to pay the United States $20.75 million to resolve allegations that DUSA caused physicians to
`submit false claims to Medicare and the Federal Employee Health Benefit Program by knowingly promoting an
`administration process for the drug Levulan Kerastick that contradicted the product instructions approved by the U.S.
`Food and Drug Administration (FDA) and was unsupported by sufficient clinical evidence.
`
`“The department is committed to protecting taxpayer-supported health care programs from fraud and abuse,” said
`Acting Assistant Attorney General Ethan P. Davis for the Justice Department’s Civil Division. “We will hold drug
`manufacturers accountable when they knowingly promote ineffective uses of their products that undermine patient care
`or waste program funds.”
`
`“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 repeatedly subjected to less effective treatments to try
`to get their skin lesions to clear,” said U.S. Attorney Brian T. Moran for the Western District of Washington. “This
`investigation seeks to restore money to taxpayers and discourage those who put profits over effective treatment.”
`
`“Drug makers that push the inappropriate use of their products undermine the health of patients and the financial
`integrity of federal health care programs, said Special Agent in Charge Steven J. Ryan of the U.S. Department of Health
`and Human Services Office of Inspector General. “Our oversight agency, working closely with our law enforcement
`partners, will continue to thoroughly investigate those who engage in such schemes.”
`
`“The OPM OIG will always seek to hold accountable those prioritizing profits over patient health and safety,” said
`Norbert E. Vint, Deputy Inspector General Performing the Duties of the Inspector General, Office of Personnel
`Management (OPM) OIG. “This settlement demonstrates the commitment of our investigative staff and partners at the
`Department of Justice to combat health care fraud against the FEHBP.”
`
`Levulan Kerastick is a prescription topical solution approved by the United States Food and Drug Administration (FDA)
`for the treatment of minimally to moderately thick actinic keratosis (AKs) of the face or scalp. At all relevant times, the
`“Dosage and Administration” section of the drug’s FDA-approved instructions described a two-stage process involving
`application of the topical solution to the target lesions and then, following an incubation period of 14 to 18 hours,
`illumination of the target lesion with blue light.
`
`The United States alleged that, by January 2014, senior management at both DUSA and Sun Pharma knew that
`administration of Levulan Kerastick employing short incubation periods ranging from one to three hours resulted in AK
`clearance rates significantly lower than those achieved in clinical trials using 14 to 18-hour incubation. Nonetheless,
`between January 2014 and December 2016, DUSA allegedly encouraged physicians to use these demonstrably less
`effective short incubation periods by using, among other things, 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
`
`2
`
`

`

`questions from prescribing doctors. The department further alleged that DUSA 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 described in the FDA-approved instructions, and, in some instances, the company
`falsely stated that AK clearance rates were the same for the shorter and less effective incubation periods.
`
` As part of the settlement, DUSA and its parent company, Sun Pharma, have agreed to enter into a Corporate Integrity
`Agreement with HHS-OIG. That agreement provides for procedures and reviews to be put in place to avoid and
`promptly detect conduct similar to that which gave rise to this matter.
`
`The settlement with DUSA resolves a lawsuit filed under the whistleblower provision of the False Claims Act, which
`permits private parties to file suit on behalf of the United States for false claims and share in a portion of the
`government’s recovery. The civil lawsuit was filed by Aaron Chung, who formerly worked for DUSA as a sales
`representative. As part of today’s resolution, Chung will receive approximately $3.5 million.
`
`The settlement with DUSA was the result of a coordinated effort among the U.S. Attorney’s Office for the Western
`District of Washington and the Commercial Litigation Branch (Fraud Section) of the Justice Department’s Civil Division,
`with assistance from HHS’ Office of Counsel to the Inspector General, FDA’s Office of Chief Counsel, and HHS’ Office
`of General Counsel.
`
`The claims resolved by this settlement are allegations only, and there has been no determination of liability. The lawsuit
`is captioned United States of America ex rel. Chung v. DUSA Pharmaceuticals, Inc., No. 16 cv 1614-JLR.
`
`Component(s):
`Civil Division
`
`Press Release Number:
`20-815
`
`Updated August 24, 2020
`
`3
`
`