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# Dusa Paying $20.75 Million on FCA Allegations
- URL: https://www.fdaweb.com/dusa-paying-20-75-million-on-fca-allegations/
- Published: 2020-08-25T12:00:00.000Z
- Updated: 2026-09-14T16:26:26.000Z
- Author: David McFarland
- Tags: Drugs, FDA Policy/General, #legacy-id-D5147511

Dusa Pharmaceuticals, a Sun Pharmaceutical subsidiary, has agreed to pay $20.75 million to the U.S. to resolve allegations raised in a whistleblower lawsuit that it caused doctors 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 FDA and was unsupported by sufficient clinical evidence. A Justice Department [statement](https://www.justice.gov/opa/pr/dusa-pharmaceuticals-pay-us-2075-million-settle-false-claims-act-allegations-relating?ref=fdaweb.com) says that Levulan Kerastick is a prescription topical solution approved by FDA to treat minimally- to moderately-thick actinic keratosis of the face or scalp.

The department says that between 1/2014 and 12/2015, Dusa encouraged doctors to use demonstrably less effective short incubation periods by using paid physician speaker programs, paid physician peer-to-peer discussions, promotion by the company sales force, and the dissemination of incomplete or misleading responses to questions from prescribing doctors. The statement also says Dusa failed to tell doctors that administering the drug using short incubation periods resulted in significantly lower actinic keratosis clearance rates than achieved with the longer incubation period in the FDA-approved instructions.

As part of the settlement, Dusa and Sun will enter into a corporate integrity agreement with the HHS inspector general.

The whistleblower, who formerly was a Dusa sales representative, will receive about $3.5 million from the settlement.