No one can toss around off-label marketing claims but the FDA. At least that's the upshot of a San Francisco federal court's decision to throw out a lawsuit against Amgen alleging improper promotion of two of its drugs.
Seven health plans had sued the drugmaker, alleging that the company had pushed off-label uses of its anemia meds Epogen and Aranesp. The two meds are approved to treat anemia in patients with kidney disease and cancer patients taking chemotherapy.
But the court was unsympathetic. In dismissing the case, the court said that it amounted to an improper attempt to privately enforce the Food, Drug and Cosmetics Act. Make your case to government regulators, the court said. Dismissed!
- read the Dow Jones story [1]
- check out the article [2] from Injury Board
Related Articles:
FDA flubs off-label enforcement [3]
Pro/Con on FDA off-label proposal [4]
Too much off-label regulation? [5]
Rep decries off-label marketing "loophole" [6]
Links:
[1] http://money.cnn.com/news/newsfeeds/articles/djf500/200812221554DOWJONESDJONLINE000476_FORTUNE5.htm
[2] http://www.injuryboard.com/national-news/amgen-anemia-drug-lawsuit-dismissed.aspx?googleid=253844
[3] http://www.fiercepharma.com/story/fda-flubs-label-enforcement/2008-07-29
[4] http://www.fiercepharma.com/story/procon-on-fda-off-label-proposal/2008-04-28
[5] http://www.fiercepharma.com/story/too-much-label-regulation/2007-12-18
[6] http://www.fiercepharma.com/story/rep-decries-label-marketing-loophole/2007-12-03?utm_medium=rss&utm_source=healthcare_pharma