Safety concerns seem to be having an effect. During the first two months of this year, the FDA approved 9 new drug applications and just one new molecular entity, compared with 16 NDAs and four NMEs a year earlier.

“This is an inauspicious start for the agency following the late 2006 Senate approval of Dr. Andrew von Eschenbach as permanent commissioner,” writes Jim Kumpel of Friedman Billings & Ramsey in an investor note this morning.

On the other hand, there were 8.75 NDAs and 0.75 NMEs approved during the first two months of the year, on average, between 2002 and 2005. “Overall, we believe the aggressive criticism of the FDA by the Institute of Medicine has forced the agency to defend and promote its efforts to ensure drug safety, resulting in a more exacting clinical trial and review process,” he adds.

And what of the rest of the year? Kumpel is optimistic, given a recent upswing in filings, but is also sobered by a Democratic Congress that is pushing safety reform. Who stands to win? He suggests contract research organizations, which will have many more clinical trials to run.

[tags]Approvals, Contract Research Organizations, FDA[/tags]