The FDA Replaces Head Of Generic Drugs Office
8 CommentsBy Ed Silverman // March 8th, 2010 // 8:48 am
The move comes just after FDA commish Margaret Hamburg complained out loud about a backlog of generic drug approvals. And so the agency has moved Gary Buehler, who directs the Office of Generic Drugs, to the Office of Pharmaceutical Science. And OPS director Keith Webber will run the OGD until a permanent OGD head is found, The Pink Sheet writes.
In a speech last month to the Generic Pharmaceutical Association annual meeting, Hamburg noted that the “unprecedented spike” in applications exceeded the agency’s review abilities. The backlog went from 891 in fiscal year 2005 to 1,912 in fiscal year 2010, according to OGD data presented at the meeting. Hamburg hopes negotiating user fees with generic drug makers will solve the problem (back story).
Whether removing Buehler, who ran OGD since 2000, will make a significant difference is unclear. The rate at which applications are submitted to the agency will continue apace, regardless, and the approval gears could even slow down for awhile thanks to the two-step transition.
Rich
The FDA needs to hop to it! People need generics and fast, hire people for crying out loud and save lives. I know that a drug I need for blood pressure is actually still under a patent. Basically for me to use it, I have to spend like $60.00 a month, but if there was a generic then I Would pay $4.00 for the drug.
ex-FDAer
Amazing. Janet Woodcock denied providing Buehler with resources and he apparently gets canned because of this.
That’s not to say that he doesn’t deserve to be canned. I personally observed Beuhler threatening a medical reviewer in the Hallway because the medical officer appropriately opposed the approval of the generics. The branded products were multiphasic release products with an immediate and a delayed release component timed to provide effects at 2 different times of the day. Beuhler was inappropriately going to approve drugs that only had a single immediate release component so the absorption clearly didn’t match the original product. He threatened the medical officer stating that if he didn’t approve generics he would have Waxman on his tail. It was simply amazing to me that he was more afraid of oversight of actions that he could have justified than of killing or maiming patients which for this product was primarily children.
JaT
Not having access to The Pink Sheet, I went searching for other reference material, and what I found appears to have nothing to do with regulation or approvals, but rather, Buehler’s perceived ability to bring the “generic drug user fee program” into play.
Gee, just as long as they have their priorities in order.
JaT
Wednesday, March 03 2010
“Gary Buehler, who has led generic drug reviews for a decade, is moving up to the Office of Pharmaceutical Science, with a brief that includes negotiating a user fee deal for generic drugs.”
Doesn’t sound like he’s being fired to me.
http://therpmreport.com/Free/firsttake.aspx
JaT
Sorry, I just reiterated what Ed has already said. I skimmed. Remove that post if you want to, Ed.
M. Black
“generic drug user fee” ?!?!?!?
Why don’t you take a dart, and shoot it straight into
my eye? Come on, I’ll give you three darts. Three…
M. Black
pharmavet
I’m rethinking the idea of a user fee for generic drugs. Remember that this was the division involved with a massive bribery scandal not that many years ago. Are we entirely sure that they’ve cleaned up their act?
pharmstudy
Janet Woodcock, is under investigation for alleged conflict of interest by Ethics. Gary Buehler is a wonderful person who opened so many doors for our generic drugs program. Margaret Hamburg needs to realize that by hiring more people they will be able to keep on top of there generics backlog, therefor the backlog will no longer exist because of haveing more manpower to process to work that needs to be done. By removing Gary Buehler it will make no difference.