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FDA caught between demand for speed and caution

March 22, 2000
Web posted at: 1:09 PM EST (1809 GMT)

By Jessica Reaves

(TIME.com) -- It's been a tough week for the Food and Drug Administration. On Tuesday, the Supreme Court dealt a decisive blow to the agency's authority, ruling the FDA does not have regulatory power over tobacco. And Wednesday, after the diabetes drug Rezulin was linked to 63 deaths and 90 cases of liver failure, the FDA finally convinced pharmaceutical giant Warner-Lambert to pull it from the market. The agency will face inevitable questions: Why would the FDA approve a drug with known toxic side effects? Can consumers trust their safety to the agency's testing standards?

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It's important to know the history of Rezulin before leveling any charges, says TIME medical writer Christine Gorman. "All prescription drugs have risks and benefits, and Rezulin was no different," she says. "Patients with liver problems had to be watched very carefully while taking this drug, but it helped a lot of people with diabetes." And that cost-benefit ratio played into the FDA's timing; the agency did not pull Rezulin until other, less toxic drugs became available.

Unfortunately for the FDA, this week's hardships are not unique. The agency is under enormous pressure from Congress and the public, says Gorman. "The FDA is expected to perform incredibly quickly -- but not so quickly that they arouse suspicion," she says. They are also chronically understaffed and underfunded, she adds. So while the public's first instinct may be to blame the FDA for the apparent weaknesses in its approval process, perhaps the scrutiny would be better directed toward the congressional leaders holding the purse strings -- and the means to more thorough regulation.

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