Pharmaceutical Business review

Novartis to pay $390m to settle US civil fraud lawsuit

The company admitted that it gave rebates and patient referrals to specialty pharmacies for recommending both the drugs.

Exjade is used to treat excess iron in blood, while Myfortic is an anti-rejection drug for kidney transplant recipients.

Novartis is still in the process of finalizing its earlier-disclosed settlement in principle with several states which filed similar civil suits related to Exjade.

The latest deal and the expected agreements with the states resolve all federal and state civil claims, including the litigation brought by David Kester on Exjade and Myfortic, as well as TOBI, Tasigna and Gleevec.

Novartis agreed to several provisions relating to specialty pharmacies as part of an addendum to its existing corporate integrity agreement (CIA), which will be extended for five years.

The company said it will implement the agreed upon controls, which include improving policies and procedures for specialty pharmacy service arrangements and contracts, training for its associates, as well as strengthened monitoring and tracking processes.

It has also agreed to provide an annual report to the government on its continued compliance on the obligations.