NDA median approval time is shortened by 7% to 15.4 months in 1996.

FDA 1996 MEDIAN NDA APPROVAL TIME OF 15.4 MONTHS IS 7% FASTER than the 1995 median time of 16.5 months, according to an analysis of 1996 review data released by FDA on Jan. 14. FDA approved 131 NDAs in 1996, a 60% increase over 1995's 82 NDAs. With eight biological approvals bringing the total number of new products approved to 139, FDA approved 63% more drugs and biologicals in 1996 than in 1995, when 85 new products were approved.

Fifty-three of the drugs approved by FDA were new molecular entities, a number 89% higher than the 28 NMEs approved in 1995 ("The Pink Sheet" Jan. 6, p. 19). For NMEs, the median approval time was 14.3 months -- 10% faster than the 1995 figure of 15.9 months. Average time to approval for the 53 NMEs was 20.5 months, slightly better than the 1995 average of 19 months.

At a Jan. 15 PhRMA press briefing, Bristol-Myers Squibb CEO and Pharmaceutical Research & Manufacturers of America Chairman Charles Heimbold asserted that "while approval times from NDA filings are improving, overall drug development times (beginning with Phase I trials) actually have increased." Heimbold cited figures from Tufts University's Center for Drug Development showing that average clinical development time for drugs approved in 1994-95 was 7.2 years, compared to 5.5 years for drugs approved from 1990-93 ("The Pink Sheet" May 29, 1995, p. 6).

"While our companies are making internal improvements to speed drug development and improve productivity of the process, we continue to need the support and cooperation of government to make a meaningful impact," Heimbold maintained. For example, FDA and industry might shorten development time by "promptly" arranging any necessary meetings, Heimbold said. "Extraneous meetings should be eliminated," he continued, and "written protocols on aspects of the development process should be created by FDA."