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FDA aims to improve drug safety, approval times

http://www.reutershealth.com/archive/2003/01/30/eline/links/20030130elin018.html

2003-01-30 10:00:14 -0400
By Doug Macron
Reuters Health
New York

Following the recent appointment of a new US Food and Drug Administration (FDA) commissioner, the agency is in the process of a sweeping overhaul that will speed product approvals, limit drug-linked adverse events, and cut the number of drug recalls, according to deputy commissioner Dr. Lester Crawford.

Speaking at the US Bancorp Piper Jaffray Healthcare conference here on Wednesday, Crawford--who was acting FDA commissioner during the roughly 2 years it took the Bush administration to fill the position full-time with Dr. Mark McClellan--noted that a number of issues clearly needed to be overcome.

Among these is the concern over adverse events once a drug has reached the market, which has made reviewers reticent to give a quick nod to investigational products.

"It's hard work being an FDA reviewer," Crawford, formerly a reviewer himself, said. A mistake can "haunt you for life," he added.

In recent years, the FDA has been forced to pull a number of high-profile drugs from the shelves after it had already given them clearance, notably Wyeth's "fen-phen" weight loss combination and the diabetes treatment troglitazone.

Between the years 1997 and 2000, the rate of post-market recalls surged to more than 5%, but Crawford said that this number is expected to fall to less than 1% over the next 2 years, given the decision to place a greater focus on FDA's post-market surveillance programs.

Under the latest incarnation of the Prescription Drug User Fee Act (PDUFA)--legislation that allows the FDA to collect fees from drug developers in exchange for meeting agreed-upon drug review schedules--the agency will begin spending a portion of the fees, $71 million to be exact, to improve its existing surveillance programs.

The FDA also hopes to reduce the number of drug-associated adverse events by reorganizing its current good manufacturing practice (cGMP) program, which Crawford said has not changed in 25 years.

The cGMP changes involve a focus on aspects of the manufacturing process that pose the greatest risk, a move Crawford expects will make the most of the FDA's limited ability to conduct inspections.

This system, he said, will be coordinated with those in the FDA who conducted the review of the particular drug being manufactured so as to focus the greatest amount of expertise on a particular inspection process.

The FDA is also having to deal with the increasing number and complexity of drugs to be reviewed, which puts a greater demand on the agency's limited resources and slows the review process.

Crawford said that the higher fees called for in the new PDUFA, as well as increased government funding to the FDA, should help this problem.
 

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