FDA’s Woodcock: Blame Pharma For Approval Rate
8 CommentsBy Ed Silverman // November 9th, 2007 // 7:48 am
Remember how more and more execs are carping about the agency? They blame the FDA for becoming too conservative in the wake of the Vioxx controversy and, as a result, fewer drugs are gaining approval.
For instance, this is from Fred Hassan, the Schering-Plough ceo: “It just indicates to you that when bureaucrats come under pressure, they tend to choose the path of asking for more data, as opposed to approving the drug.â€
Wyeth’s Bob Essner recently fumed: “If you’re the first company to get approved in a certain area and competitors can’t get on the market, the FDA is now establishing monopolies. And that’s certainly not their mandate.â€
And this is what Dan Vasella at Novartis had to say: “The discussion on what this drug brings over and above what’s on the market is a question that’s being asked. The FDA doesn’t seem to trust the physicians any more.â€
But wait a second fellas. Someone else thinks the slow rate of approvals is your fault. FDA deputy commissioner Janet Woodcock blames pharma. “I know the CEOs think we have become extremely conservative, but the standard for getting a drug approved has not changed,” she tells Fortune. “The number of new drug approvals is directly proportional to the number of applications we receive. It’s because we’re getting fewer submissions.”
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Lisa Van S
Hey Ed,
Cant wait for Dr. Scott Gottlieb over at AEI to chime in. I am sure he’ll have an Oped piece by Monday Morning.
Nathan
I’m still trying to figure out if an “approvable” letter is considered an “approval”. Just judging from press releses, it’s hard for me to believe that 21 out of 23 applications in 2006 were “approved”. I would find it far more likely that 21 out of 23 were “approved or approvable” and 2 were rejected. Note that you can’t see an “approvable” drug… Does anyone have a source of more specific numbers where “approved” and “approvable” are broken down?
Patrick Clinton
Approvable letters are interesting and a pretty hot topic in the industry. If you’d like to read more, come to http://www.pharmexec.com (I’m the editor), and click on the article headline.
Nathan
Patrick,
That’s a great article — I hope you don’t mind, I’m going to pull a few facts from the article for readers at this site to consider:
2001-2004: 35 “approvable” letters were sent (total)
Jan 2006- Oct 2007: 36 “approvable” letters
Average delay to market by recieving an approvable letter: 20 months.
“In 2005, only one of 14 me-too drugs won approval on the first try” (the other 13 recieved “approvable” letters)
Kerry
Call Janet Woodcock and ask her why she did not provide a copy of the letter she received from Fleming and Hussain to the FOIA offic of the FDA as they requested of her. She is violating the law by not providing them and she is violating a court order if she destroyed them.
Also why did she not provide the means of communication of those letters to her as requested.
While you are at it ask her who sent the letters to the Cancer Letter and which person came up with the idea to do so.
Bob
My $.02,
Is if Pharma presented statistics ike Dr. Woodcock has presented we would receive a refusal to file letter. Seriously, what is missing here are a few things:
- Many drugs do not receive first pass approval (10 months). They are submitted in one year and approved in later years.
- All NDA submissions submitted after March are approved the following year
- The number of submissions is not the indicator here. It’s the length and size of the clinical programs required to support the submissions. Programs never use to have tens of thousands patients to support registration.
The list goes on, but FDA certain cannot blame this on big pharma for this one. We have pre-IND meetings and end of phase II meetings where they add studies and time. This is even before we submit. Additional on the chemistry manufacturing and controls side drug approvals are delayed for reasons having nothing to do with safety or efficacy.
johnny blaze
Nathan: The number of approvals in any given year doesn’t correlate to the number of applications for that year–since the approval process often straddles more than one calendar year.
(For instance, an application filed in September could be approved in March of the following year.)
tony stark
Bob: Why are you over-complicating this? The numbers aren’t meant to be seen as a year-over-year comparison. These stats support Woodcock’s claim. The fact is, companies have been submitting fewer applications in the last few years–period.