MOST NEW ACTIVE DRUG INGREDIENTS APPROVED AFTER JUST ONE REVIEW, REPORT SAYS

The FDA in the past 18 months has approved most new active drug ingredients after only one review, but those under standard review require a second go-around far more often than those under priority review, according to a report by Barnett International on U.S. drug approval trends.

A new molecular entity (NME) is an active substance that has never before been approved for marketing in any form in the U.S. NMEs are given priority review if they appear to provide a significant improvement compared with products already on the market, and given standard review if they appear to have therapeutic qualities similar to drugs already on the market.

Of the 27 NMEs approved between 2005 and mid-2006, 17 were approved in the first review cycle, while seven took two review cycles and three required a third cycle. But of the 18 under priority review, all but four were approved in the first go-around, while only three of the nine under standard review were cleared after the first cycle.

It is taking longer on average for the FDA to complete its first review of an application to market an NME -- 7.6 months last year compared with 8.4 months this year -- but less time for priority reviews and more time for standard reviews.

It is also taking longer for drugmakers who want to market an NME to submit a response when the FDA deems an application approvable or not approvable. For NMEs approved in 2005, drugmakers on average took 11.5 months to respond, compared with the 7.6 months it took for the FDA to complete the review.