New drug approvals by the FDA have fallen further behind last year’s levels, with just 59 NDA approvals through October, down 29 percent year-over-year from last year’s 83, and 13 percent below the 10-year average of 68 NDAs, writes Jim Kumpel, an analyst at Friedman Billings Ramsey, in an investor note this morning.

More importantly, the 14 new molecular entity (NME) approvals through October represent an 18 percent drop year-over-year and is 22 percent below the 10-year average of 18 NMEs. That said, the four NME approvals in October represent the high water mark for NMEs in 2007, although that’s still down 20 percent from the prior October, he notes. Biologics approvals have fallen off a cliff in 2007, he adds, with just one year so far this year, compared with four at this time in 2006. (Click on the chart to make it bigger; blue is NDA and red is NME).

The “NDA approval ratio appears to be on track for the lowest level since 1994,” Kumpel writes. “We have reviewed 40 years worth of NDA submission and approval data to put 2007 into perspective. While some pundits have argued that the pipeline of NDAs submitted to the FDA by the pharmaceutical industry has been weak in recent years, the facts dispute such claims.

“Since 1986, only three years have featured NDA submissions above 126, while the rest of the period has stayed remarkably steady in the range of 98 to 125. The number of NDAs approved each year has been much less predictable, resulting in the ratio of NDAs approved to NDAs submitted ranging from 49 percent in 1987 to 109 percent in 1996. The approval ratio has only dropped below 60 percent in two years since 1989. However, with NDA approvals down nearly 30 percent year to date in 2007, the NDA approval ratio could come down from the 76 percent level of 2006 to something less than 60 percent, would represent the lowest level since 1994.”

Intererstingly, FDA deputy commish Janet Woodcock recently blamed the slow rate of approvals on pharma, which insists the problem is because the FDA is more cautious. “I know the CEOs think we have become extremely conservative, but the standard for getting a drug approved has not changed,” she said. “The number of new drug approvals is directly proportional to the number of applications we receive. It’s because we’re getting fewer submissions.” A temperature reading in the form of a Pharmalot poll found many disagree when asked who is to blame.

FDA? 44 votes, or 59 percent;
Pharma? 30 votes, or 41 percent.