Dancing the FDA tune

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Monday, May 1, 2006 - Page updated at 12:00 AM

http://seattletimes.nwsource.com/html/editorialsopinion/2002960020_druged01.html

Editorial

Dancing the FDA tune

The Food and Drug Administration needs serious reform

and Congress must stop dancing around the fact.

The FDA's failures over -2 inhibitors were widely

documented. The painkillers Vioxx and Celebrex were

heavily marketed and then found to increase users'

risks of heart attack and stroke. Vioxx was recalled.

A Celebrex trial was halted. Now come congressional

investigators with a damning conclusion to their

critique of the FDA: The agency doesn't have a

reliable process for tracking safety problems

involving drugs already on the market.

The report by the Government Accountability Office

reinforces this page's view that the FDA needs help

balancing its mission of regulator for public health

with its role helping get new drugs to market.

The public has little confidence in the FDA. To

restore the public's trust, the FDA must become a

stronger, more-assertive version of its passive self.

The agency needs a stronger hand in forcing

pharmaceutical companies to conduct safety studies of

drugs already in use by the public. Congress ought to

get behind the efforts of Sen. Grassley,

R-Iowa, who has proposed drug-safety legislation

requiring companies to respond with studies when

safety concerns about existing drugs arise and spread.

The FDA would be given the authority to punish

companies that don't fall in line with heightened

safety requirements.

The pharmaceutical industry doesn't support increased

requirements. But let's not forget the disclosures

that drug giant Merck and federal regulators allowed

Vioxx to remain on the market despite growing evidence

of its dangers.

Congress should support Grassley's sharply focused

reform efforts. The Iowa senator's view of the FDA is

admirably lucid.

The Government Accountability Office has laid to rest

any lingering doubts about the FDA: The agency fails

when it comes to drug safety. Time now to fix the

broken system.

Copyright © 2006 The Seattle Times Company