Daiichi Sankyo Agrees to Pay $39 Million to Resolve Off-Label and Kickback Allegations; Enters into Corporate Integrity Agreement with OIG

Discussion programs, known as “PODs,” from Jan. 1, 2005, through March 31, 2011, as well as other speaker programs from Jan. 1, 2004, through Feb. 4, 2011.  The company allegedly made payments to physicians “when physician participants in PODs took turns ‘speaking’ on duplicative topics over Daiichi-paid dinners, the recipient spoke only to members of his or her own staff in his or her own office, or the associated dinner was so lavish that its cost exceeded Daiichi’s own internal cost limitation of $140 per person,” according to DOJ.  The complaint alleges that "[a]bsent Defendant’s unapproved, illegal off-label marketing, which included false representations, and its gifts to physicians, the subject drugs would not have been prescribed by physicians for off-label indications.”  Importantly, Daiichi did not admit to the allegations. They settled for $39 million, and in the process avoided the risk of going to trial and losing—resulting in the "death sentence" of exclusion from Medicare, Medicaid, and other federal healthcare programs.  Warning Letter For Benicar In 2006, the Food and Drug Administration sent a Warning Letter to Sankyo (before the merger with Daiichi Pharmaceutical) due to the company’s promotion of Benicar. FDA found that Sankyo had made unsubstantiated superiority claims over other angiotension II receptor antagonists. “The studies did not generate valid data to support the product comparisons because, ...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs