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Sun Pharma Resolves Incubation Rate Misinformation Allegations

— September 9, 2020

DUSA misguided patients using acne ointment, leading to a lower success rate.

Sun Pharmaceuticals’ subsidiary DUSA Pharmaceuticals, Inc., agreed to pay nearly $21 million to settle allegations of providing false instructions to physicians related to its product Levulan Kerastick, a topical acne ointment used with a blue light.  Because of this, not only were medical personnel and patients misguided, but federal health care programs overpaid for the treatment.

According to the Department of Justice (DOJ), clinical trials using Levulan Kerastick called for 14 to 18 hours of incubation.  However, DUSA, acquired by Sun in 2012, encouraged doctors use just one to three hours.  This resulted in lower success rates for the treatment.  The federal agency said the drug maker “failed to tell doctors that administering shorter incubations resulted in those lower rates and sometimes maintained that clearance rates were the same for shorter and longer incubation periods.”  While misleading physicians, the company also asked them to participate in paid speaker programs.  The scheme occurred between January 2014 and December 2016.

Photo by Tom Claes on Unsplash

“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.”

The DOJ probe commenced after a whistleblower lawsuit was filed four years ago by a former DUSA sales associate under United States of America ex rel. Chung v. DUSA Pharmaceuticals, Inc., No. 16 cv 1614-JLR.  As part of the settlement, DUSA Sun have agreed to enter into a Corporate Integrity Agreement with the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG), an agreement which will allow third-party monitoring of its operations in order to avoid similar issues moving forward.

“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.”

“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 HHS-OIG.  “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.”

A spokesperson for Sun responded, “DUSA fully cooperated with the Justice Department its investigation, and we are happy to have reached a resolution.”


Sun Pharma unit to pay $21 million for giving docs false instructions for a skin treatment

DUSA Pharmaceuticals To Pay U.S. $20.75 Million To Settle False Claims Act Allegations Relating To Promotion Of Unsupported Drug Administration Process

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