Word: fda
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Dates: during 1990-1999
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...maybe it should be. Panelist Henry Blackburn, a professor of public health at the University of Minnesota, thinks federal standards aren't stringent enough. "Drugs have to produce evidence of benefit, but food supplements do not," he points out. He is also troubled by the fact that the FDA has no money to do its own studies and thus has to rely almost entirely on research done by the petitioners. cspi's Jacobson too is concerned that responsibility for demonstrating a food's safety is shifting to the wrong hands. He notes, "Judging from the FDA's handling of olestra...
WHETHER OR NOT FDA COMMISSIONER DAVID KESSLER decides to approve olestra, his ruling is sure to be bitterly attacked. That's nothing new for the maverick scientist (and, by training, doctor and lawyer), who in his fifth year as the U.S.'s top health official has achieved a rare combination of public controversy and political longevity. He heads the agency everybody loves to hate, yet he's outlasted most of his predecessors...
...Kessler usually does. The FDA's scope is extraordinary, ranging over $1 trillion worth of products, from breast implants to orange juice. In one 10-day period last month the agency approved a new aids drug, issued new rules on seafood safety, approved the first treatment for Lou Gehrig's disease and banned nighttime laser shows in Las Vegas...
...Kessler's agency is most often criticized not for its actions but for its inaction--for letting the approval process for new medical advances drag out for years and even decades. Virginia Republican Thomas Bliley, the pro-business chairman of the House Commerce Committee, ridicules the FDA's drug-approval procedures as "paralysis by analysis." The Washington Legal Foundation, a vociferously antiregulatory group funded by conservative organizations and companies, has relentlessly attacked the FDA through lawsuits, press releases (sometimes printed on lurid pink and purple paper) and a series of vitriolic print ads. "If a murderer kills...
...delays and cautiousness were FDA hallmarks long before Kessler arrived. His defenders say he has made every effort to speed things up. Even while acknowledging that some approvals still take too long, Kessler points out that the time it takes the agency to okay a new drug is about 19 months, down from 33 months in 1987. In fact, the FDA's responsiveness to aids and certain life-threatening diseases has surprised some early skeptics. Five of the six antiviral drugs used to treat AIDS were first approved in the U.S. The anticancer drug Taxol, the first multiple sclerosis drug...