/publications/issue/2006/2006-03/2006-03-5291

REPORT SUGGESTS MORE TALKS FOR FDA AND DRUGMAKERS

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A new government report advises that new medicines could reach the US marketplace faster if FDA officials consulted with more drug manufacturers before the final phase of human testing and made sure that the manufacturers were dealing with potential difficulties.

An analysis of 77 drug applications submitted to the FDA from 2002 to 2004 found that 52% of manufacturers that consulted with the agency at that time were granted approval following an initial review. On the other hand, only 29% of companies that had meetings after the initial review received approval for their products during the original cycle.

The report, compiled by the consulting firm Booz Allen Hamilton at the FDA's request, indicated that drugs that do not win FDA approval after the original review of about 6 to 10 months may face multiple evaluations before reaching the market.

The report's findings showed that applications that do not make it through the first cycle often had limitations in 1 or 2 areas. Companies might have been able to resolve the problems if FDA officials had expressed clear concerns early. The FDA also should compile a checklist of issues and follow up with companies to see whether the problems are being handled. "Early and open communication with the sponsors will allow sponsors to address/ resolve issues in a timely manner, potentially within the first review cycle," the report stated.