February 08, 2006
Report finds more meetings with FDA could mean faster product approval
New medicines could reach the US market faster if more drug makers met with the FDA prior to the final phase of testing to make sure they were addressing potential pitfalls, a report released yesterday said.
According to an analysis of 77 drug applications submitted to the FDA from 2002 to 2004, 52% of drug manufacturers that held meetings with the FDA prior to final phase testing won initial review product approval. The original cycle approval number shrank to 29 % for companies that failed to conduct final phase meetings with the FDA. The study was conducted by consulting firm Booz Allen Hamilton at the FDA’s request.
The FDA, however, would have difficulty conducting additional meetings given its current staff size, a top agency official said.
John Jenkins, director of the FDA’s Office of New Drugs told Reuters that, “any additional workload for meetings is going to have to be supported by additional staffing.”
Jenkins added there was “always room for improvement” in the way the FDA communicates with drug makers but “some of the burden relies on the sponsors to make sure they understand what is being told.”
The report also found:
*Applications that fail during the first cycle often had shortcomings in only one or two areas.
*Smaller companies generally had more trouble gaining FDA approval after the first review.