REPORT SUGGESTS MORE TALKS FOR FDA AND DRUGMAKERS

Pharmacy Times, Volume 0,0

A new governmentreport advisesthat new medicinescould reachthe US marketplacefaster if FDAofficials consultedwith more drug manufacturers before thefinal phase of human testing and madesure that the manufacturers were dealingwith potential difficulties.

An analysis of 77 drug applications submittedto the FDA from 2002 to 2004 foundthat 52% of manufacturers that consultedwith the agency at that time were grantedapproval following an initial review. On theother hand, only 29% of companies thathad meetings after the initial reviewreceived approval for their products duringthe original cycle.

The report, compiled by the consultingfirm Booz Allen Hamilton at the FDA'srequest, indicated that drugs that do notwin FDA approval after the original reviewof about 6 to 10 months may face multipleevaluations before reaching the market.

The report's findings showed that applicationsthat do not make it through thefirst cycle often had limitations in 1 or 2areas. Companies might have been able toresolve the problems if FDA officials hadexpressed clear concerns early. The FDAalso should compile a checklist of issuesand follow up with companies to seewhether the problems are being handled."Early and open communication with thesponsors will allow sponsors to address/resolve issues in a timely manner, potentiallywithin the first review cycle," thereport stated.