Reuters began running a story by Ransdell Pierson in the last hour, which (tangentially) claims that Fred Hassan worked for J&J in 2003. That can't be right. By April of 2003, he was under a ridiculously-lucrative contract, and working full-time at Schering-Plough. Prior to that, he was selling Pharmacia to Pfizer. Must be a typo.
In any event, his actual quote is. . . well, ironic -- given what happened on his watch at Schering-Plough, after the ENHANCE clank (and attendant disclosure delays), when he was then given an FDA "no way", on Cordaptive® that Spring, and an "unapprovable" letter from FDA -- on Bridion® (sugammadex) that Summer (2008).
. . . .J&J's consumer unit problems could spill over into its other, more profitable, businesses if the FDA begins to scrutinize those divisions as well, one industry expert said.
"If regulators start to distrust management, then they start being strict with everything, and checking and inspecting everything," said former Schering-Plough Chief Executive Fred Hassan. J&J [sic] hired Hassan in 2003 to clean up a quality control disaster [ID:nN03224575]. . . .
[Ed. Note: I think you mean Schering there, tiger.]
Indeed, as I wrote at the time Bridion clanked: ". . .it seems [concerns about] deficient data sets out of Schering-Plough are an emerging theme -- first from two Congressional Committee Chairs, now FDA. . . ." It ultimately got so bad that by July 2008 Mr. Hassan was quoted in The Wall Street Journal as saying he no longer had "any idea" what it would take to get a drug approved at FDA.
What goes 'round -- really goes 'round, eh Freddo?
4 comments:
So we've got, problems with Enhance, Cordaptive, and Bridion all in the spring / summer 2008 time frame.
We also had Fred go ballistic on the front page of the WSJ on June 30, 2008.
http://shearlingsplowed.blogspot.com/2008/06/it-is-usually-unwise-to-complain-about.html
Now we've got Fred's comments here about spill over, distrusting management, and checking and inspecting everything.
Well I remember the following post about the FDA reviewer saying SP tried to hide toxicities and indicated that studies were specifically designed to hide them.
http://shearlingsplowed.blogspot.com/2009/07/fda-reviewer-on-asenapine-schering.html
By the way guess the original PDUFA due date? That's right the FDA docs say it was June 30, 2008.
But we didn't hear anything out of FDA until the following January, and 3 weeks later Fred sold SP to Merck.
Do you think if someone starts to mistrust Fred that they may start to take a closer look not only at other drug's he's worked on but also B&L.
Salmon
Poor Fred. So miss understood. He's really the 'turnaround' guy, earning trust everyday!
Cue violins.
Reuters finally corrected the error.
Namaste
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