Friday, June 29, 2007
- In what sounds like an approvable letter for Symbyax (which is a fixed dose combination of Zyprexa and Prozac), the FDA (via Pharmalot) expressed concern about the safety data disclosed in the proposed label. I'm not particularly convinced that it will materially increase the number of cases (as suggested in the Bloomberg story) -- is there a Zyprexa user in the universe who doesn't know about the fact that litigation exists? -- but if it tolls the statute of limitations (again I'm doubtful), I suppose the marketing could continue to find new patients.
- Via Bloomberg (and also noted at Point of Law; related post at Drug & Device Law), Judge Weinstein denied summary judgment in a class action brought by third-party payors alleging overpromotion, in particular of off-label uses. Perhaps this will quiet those who, during the document leak fiasco, contended that Weinstein was in the pocket of Lilly.
(Usual disclosure: I do some work for pharma companies. Lilly is not and never has been a client.)