US gov demands more information from Novartis on purported kickbacks
- The Manhattan U.S. Attorney is asking Novartis to provide documents on 80,000 events in which the government alleges doctors were taken out to expensive dinners in return for prescribing Novartis cardiovascular drugs, according to Bloomberg.
- Novartis and the government are battling in an ongoing whistle-blower lawsuit in the U.S. District Court in Manhattan. Novartis is accused of providing illegal kickbacks to physicians via fabricated educational programs which were used as a cover for treating physicians.
- In response, Novartis has accused the government of “exploding” the case and recently requested a hearing.
Efforts by the U.S. government to combat physician kickbacks—rampant in the 1990's and early 2000's—have been somewhat successful, but not entirely. Last year, Novartis paid $390 million to settle a kickback case involving tactics to increase sales of Myfortic, Exjade, Tasigna, Gleevec and TOBI.
The new charges allege physicians were treated to expensive dinners and given honoraria under the guise of educational events designed to provide continuing medical education. Government lawyers are seeking evidence of whether the events actually included educational discussions and even if the events actually occurred at all.
In 2003, the Office of the Inspector General (OIG) released guidance to ensure compliance with the federal Anti-Kickback Statute, which prohibits any form of payment intended to induce or reward referral of patients covered by federal health insurance.
Under these rules, cocktail service is forbidden and beer/wine should only be consumed during dinner. Total spending per physician cannot exceed $125.
The case is U.S. v. Novartis Pharmaceutical Corp. in the U.S. District Court, Southern District of New York (Manhattan).