A Massachusetts-based pharmaceutical firm has agreed to pay the Federal government over $20 million to settle claims by the U.S. Food and Drug Administration that it led doctors to make claims to Medicare for prescribing their drug for a non-approved usage.
Federal prosecutors say the firm’s top management began to be aware that its drug was dramatically less effective against keratosis during shorter incubation times than it was for longer ones in early 2014. Although the FDA approved the drug for use in the more effective long-incubation applications, prosecutors say the firm began to encourage doctors to prescribe it for the unapproved shorter term throughout 2014 and to the end of 2016.
Per prosecutors, the firm went to great lengths to promote the unapproved usage. They said the company paid speakers to promote the off-label usage, used paid peer-to-peer discussions among doctors, and gave misleading responses to doctors that inquired about the shorter usage times. The firm did not tell doctors of the lower effectiveness of the drug, say prosecutors, and they allegedly went so far as to say that there was no difference in outcome between the shorter and longer incubation rates.
In addition to paying the Federal government $20.75 million, the firm has agreed to enter into a corporate integrity agreement with the U.S. Department of Health and Human Services Office of Inspector General. The program is intended to aid the firm in establishing policies and procedures that would act to prevent a similar situation from occurring again in the future.