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...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...
...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...
Last year, after making its way through the nation's appeals courts, the argument over FDA regulation of tobacco landed in the Supreme Court. Tuesday's ruling, which was accompanied by Stephen Breyer's scathing dissent, pushes tobacco back into congressional hands. Anti-smoking forces worry that the Court's decision could weaken the tobacco industry's newfound resolve to voluntarily enhance warning labels on cigarettes and step up efforts to keep minors from smoking. But while Tuesday's ruling is certainly a victory for tobacco - sending Philip Morris's stock through the roof - the triumph could be short-lived...
...Monday, tobacco was a drug regulated under federal law. On Tuesday, that all stopped. The labyrinthine legal two-step between the tobacco industry and its foes continued when the Supreme Court ruled 5-4 that the FDA does not have the right to regulate tobacco as a drug. That the high court was in a position to rule on this at all is an indicator of how convoluted the reasoning in this case has become. For 60 years, the FDA followed its self-imposed hands-off policy on tobacco because, it reasoned, cigarette makers never claimed their product provided health...