FDA ON TRACK FOR RECORD YEAR IN NDA APPROVALS

October saw the highest number of drug approvals of any month in 2006, which could become a record year for drug approvals, according to research by Friedman, Billings, Ramsey (FBR).

So far in 2006, the FDA has approved 83 new drug applications (NDAs), on track with results from 2004, the best year for approvals during the Bush administration.

October contributed 15 of the approvals. By comparison, October 2005 had only six approvals, and there were 68 approvals total at this point last year.

The pickup in approvals supports the view that 2007 will see a significant increase in drug launches, FBR said. It added that the FDA seemed to be handling applications that had piled up after safety controversies surrounded Cox-2 inhibitors in late 2004.

Average drug approval numbers are significantly lower under the current administration than under the previous one, according to FBR. The Bush administration averages 82 approvals a year, as opposed to 92 a year under the Clinton administration. Having a permanent agency commissioner in place could help increase the number of approved NDAs by calming the "endemic risk aversion of the bureaucrats in the FDA," FBR said.