DUSA Pharmaceuticals fined $20.75 million for fudging dosage requirements

Society of Corporate Compliance and Ethics (SCCE)

Society of Corporate Compliance and Ethics (SCCE)

CEP Magazine (November 2020)

The U.S. Department of Justice and DUSA Pharmaceuticals Inc. (DUSA) agreed to settle False Claims Act allegations through a fine and a corporate integrity agreement that requires DUSA to implement reviews and procedures to prevent similar problems in the future.

According to a Department of Justice news release,[1] the Levulan Kerastick requires a 14- to 18-hour incubation period to be effective. DUSA allegedly paid physicians to communicate to consumers that Levulan Kerastick had a three- to eight-hour incubation period, making the drug less effective but seemingly more convenient.

According to the news release, “‘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.”

1 U.S. Department of Justice, “DUSA Pharmaceuticals To Pay U.S. $20.75 Million To Settle False Claims Act Allegations Relating To Promotion Of Unsupported Drug Administration Process,” news release, August 24, 2020, https://bit.ly/34QIKGA.

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Society of Corporate Compliance and Ethics (SCCE)

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