Consumer groups see need for greater reform

`Why were unsafe drugs being sold in first place?'

April 08, 2005|By Susan Baer | Susan Baer,SUN NATIONAL STAFF

WASHINGTON - In recent years, critics have said the Food and Drug Administration focuses too much energy on approving new drugs and pays too little attention to health risks from medicines once they're on the market - and used by a much larger population.

Two months ago, responding to that criticism on the eve of hearings examining the safety of Bextra, Celebrex, Vioxx and other painkillers, the FDA announced the creation of an oversight board to aggressively monitor drugs once they're on the market and tell the public about emerging health risks.

FDA critics have questioned the independence of such a board. And many said yesterday's announcement that Bextra would be yanked from the market and other painkillers would be sold with tougher warnings underscores the need for a major FDA reform beyond its new oversight board.

"Removal of a dangerous drug from the market is a good thing, but it leads to the larger question - why were these unsafe drugs being sold in the first place?" said Jeannine Kenney, senior policy analyst for Consumers Union.

CU and other consumer groups said they favored a drug safety office with the authority to actively monitor drug safety, require drug companies to conduct post-market safety studies and take action if problems arise.

Sen. Charles E. Grassley has been working on legislation to increase the authority of the agency's drug safety operation and detach it from the FDA's Office of New Drugs.

The Iowa Republican said yesterday that the "confusing saga" surrounding the painkillers pointed to "systemic failures by the FDA and misplaced priorities of the drug industry."

But Grassley said he hoped yesterday's actions, which go further than the recommendations of the FDA's advisory panel, was a "turning point" and reflected a more independent FDA.

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