New Drug Approvals Are Down… Way Down
7 CommentsBy Ed Silverman // October 8th, 2007 // 7:45 am
And can we blame it on Bush? During the first 81 months of the Bush administration, drug approvals have significantly lagged the averages logged under the Clinton administration, Jim Kumpel, an analyst at Friedman Billings Ramsey, writes in an investor note this morning. Under Bush, the FDA has averaged 80.7 new drug application and 20.6 new molecular entity approvals per year. During the Clinton era, there were annual averages of 92.1 NDA and 32.4 NME approvals.
So far, this year is shaping up terribly. New drug approvals by the FDA have plunged from last year, with just 51 NDA approvals through September, down 25 percent year-over year from 68 in 2006 and 13 percent below the 10-year average of 59, Kumpel notes. More importantly, the 10 NME approvals through September represent a 17 percent drop year-over-year and matches a 10-year low, down 40 percent from September 2004 levels. (Click on the chart below to see some numbers).
“The dramatic slowdown in new drug approvals may be magnified by the recent reauthorization of the prescription drug user fee act (PDUFA), which should further safety standards. Companies that depend on new drug approvals - whether large pharmaceutical manufacturers, contract sales organizations, or new drug launch consultants - are clearly feeling the pain in 2007,” Kumpel writes.
If there’s a bright spot, contract research organizations benefit from greater safety demands as average trial size increases, contract duration lengthens, and backlog visibility grows,” he concludes. UPDATE: This report doesn’t refer to approvals for biologics, which can be seen here, and so the total output of the biopharma biz, when taking into account such biotech products, would look differently.
Blue = NDA and Red = NME
Peter Pitts
Um, perhaps approvals are down because the pipeline is dry?
Ed Silverman
Hi Peter,
Yes, that would be a consideration, but for some more than others. There’s also the unexpected hiccup, such as the kind Wyeth has experienced in the form of approvable letters. It appears unlikely there’s just one reason to explain this across the board.
Cheers
ed
Your Cancer: Your Choice » Blog Archive » Slowdown in new drug approvals, especially those fighting cancer
[...] Pharmalot looks at it by administration, noting that under Bush, the FDA averaged 80.7 new drug application and 20.6 new molecular entity approvals per year. During the Clinton era, there were annual averages of 92.1 NDA and 32.4 NME approvals. More notably, so far this year there’s been a 25% decline in NDA approvals from the same period a year ago (Pharmalot) [...]
Michael D. Miller, MD
This is an often misunderstood statistic. What the chart and your discussion shows is that approval of new “drugs” (NDAs) has been flat or declined (depending on the time period examined). However, what you are missing are the approvals of biologics - which are approved as biological licensing applications (BLAs) by the FDA. Unfortunately, because BLA are fundamentally different than NDAs and are approved by CBER (Center for Biologics Evaluation and Research) which only recently was merged with CDER (Center for Drug Evaluation and Research), the data about new BLAs that are similar to NDAs (or NMEs) is not easy to come by. (For good regulatory and scientific reasons CBER didn’t categorize BLAs the same way CDER had categorized NDAs) However, by looking at the new medicines (i.e. both drugs and biologics) that have been approved by the FDA in the last 10 years or so, it is clear that the number of biologics has increased significantly. The addition of this data changes the analysis and conclusions about the output and productivity of the biopharmaceutical industry….. And lastly, although some people argue that it is the biotechnology industry that produces these new “biotech” drugs (i.e. biologics), traditional pharma companies have been producing essentially as many as the newer biotech companies such as Amgen and Genzyme…..
Ed Silverman
Hi Michael Miller,
That’s another good point. While I didn’t intend to suggest the overall output of biopharma was waning, I should’ve specified that biologics are a different animal and took up some of the slack. Thanks for underscoring this issue. And for taking the time to write in.
Regards
ed at Pharmalot
Tony F
Ed,
As mentioned, could it be that the CR letters are constipating the new development pipeline?
In the example of Dendreon and it’s UNexpected CR letter at the beginning of May for its prostate cancer therapy, Provenge, Dendreon has a deep pipeline which has had to be put on “Hold” for the past year or so in order to devote the company’s limited fiscal resources to the Provenge approval.
Neuvonge, for BREAST cancer, and other Dendreon products are delayed–UNnecessarily, imo–due to the FDA and Maha Hussain of Univ of Michigan and Howard Isador Scher of Sloan-Kettering in NYC shennigans anit-Provenge and due to Hussains’s and Scher’s alleged list of UNdisclosed list of Conflict of Interests.
If this is happening to Dendreon and their pipeline of new, innovative therapies, it can be extrapolated to many other biotechs and pharmaceutical companies as well.
I believe a successful CareToLive lawsuit against the FDA and Richard Pazdur of the FDA and Scher–both in their individual capacity in the Provenge saa–will open a crack a LOT wider in the treatment development process… clean out the apparent crooks and get back to looking at new developments on their MERITS and more approvals should be forthcoming.
Thanks for you continuing exposure of these types of debacles!
Hank
Good points made by all. I think I hear echoes of that “Casual Observer” I met the other day.
Also glad to _not_ hear the usual blame game from all sides: it’s the fault of FDA over-caution, greedy trial lawyers, industry relying on me-too drugs, low-hanging fruit all picked, etc. Not to say that there may not be something to be said re: such dimensions. Just good not to hear them as lobbed “talking points.”