US FDA Testing Quicker Drug Development Systems

December 16, 2003

By Richwine

WASHINGTON (Reuters) Dec 15 - U.S. regulators are testing ways to help speed

drug development, such as allowing companies to submit applications in

pieces to get early feedback, Food and Drug Administration Commissioner Mark

McClellan said on Friday.

The pilot programs are part of McClellan's broad effort to reduce the time

and cost it takes to bring new medicines to the market, a key concern for

pharmaceutical companies.

With so-called rolling submissions, companies can send the FDA parts of

their applications as they complete them. The goal is to enable agency

reviewers to identify deficiencies early, or let companies know they are on

the right track.

" We're going to see if that makes a difference in avoiding repeat (review)

cycles, " which delay a drug's entry to the market by months or years,

McClellan told Reuters in an interview.

The process is being tested for " priority " applications for drugs or biotech

treatments that show promise for treating serious conditions with no current

therapies, McClellan said.

In another effort to encourage early consultations, the FDA will have

" extensive " contact with companies even before they begin human testing of a

medicine's safety and effectiveness.

Agency reviewers have drawn criticism in some cases for failing to

communicate clearly with drug companies about their applications. Or if they

did, it was often late in the process, after costly tests were completed.

Regulators also are trying to provide companies with more information in

advance about how to develop products in specific areas in which science is

moving rapidly, McClellan said.

" We are committed to reducing the total time to review of new products ...

we're not going to be able to meet those goals though unless we can provide

some very clear guidance, and unless we get some higher quality

applications, " he said.

" The best way to do that is, No. 1, share our expertise and, No. 2, hold a

lot of public discussions on what seems to be working and what doesn't in

the development process, " McClellan said.

The agency hopes to release progress reports next year on various efforts to

improve the drug development and review process, he added.

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