Comments on: ZymoGenetics, King Pharma Brawl Over Drugs to Control Surgical Bleeding

By: Sarah Lake

Sarah Lake — Fri, 04 Dec 2009 18:36:42 +0000

Interesting, just 2 deaths in 14 years (or 14 million cases, according your acticle) -not much evidence…

By: Luke Timmerman

Luke Timmerman — Tue, 10 Nov 2009 20:01:52 +0000

JK—this story does include a reference to the FDA’s warning to ZymoGenetics about its marketing practices in April 2008, but that’s nothing new. The more interesting question is whether ZymoGenetics has crossed the line in its marketing again in the view of the FDA, and I don’t know the answer to that. Certainly, the company stepped up its attacks on King with the citizen petition in August, and it will be interesting to see how the FDA views this new tougher communication to doctors. If you have any evidence of them, or King, or anyone else making claims to physicians that are flat wrong or misleading, I’d like to look into that as a follow up. –Luke

By: JK

JK — Tue, 10 Nov 2009 14:32:33 +0000

I am an unbiased observer to this case but as a person familiar with FDA activities I must say that this is a very poorly researched article. While the article is correct when it quotes Mr. Miller as saying that “The FDA is the arbiter of proper marketing materials for approved drugs,” the article (and Mr. Miller) fail to mention that in April of 2008 the FDA’s division that reviews marketing materials actually sent an untitled letter to Zymogenetics claiming that some of its promotional materials were misleading and therefore in violation of FDA rules on product promotion (http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/Enforcement/UntitledLetters/ucm093490.htm). These materials specifically related to Zymogenetic’s claims vis-a-vis King’s product and were mentioned in King’s lawsuit. While it is unclear if Zymogenetics is still making similar claims and unclear whether they patched things up successfully with the FDA, the letter is clearly relevent to the case. The letter also calls into question the second half of Mr. Miller’s quote “As long as Zymo is using approved materials, and they are, this suit goes nowhere.” I agree that if Zymogenetics is using appropriate materials they are safe, but the FDA reviews (rather than approves) individual advertising peices and it is not clear that the FDA agrees with Zymogenetics’ marketing activities.