Word: fda
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Dates: during 1980-1989
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Deodorant soap, pacemakers, food-color additives, blood banks, coffee, tongue depressors, eyeglass screws, tampons and cancer drugs -- all come under the scrutiny of the Food and Drug Administration. The FDA certifies the purity and safety of one-quarter of all U.S. consumer products, in addition to regulating the $400 billion food, pharmaceutical and medical-devices industries. But throughout the 1980s the FDA has been traumatized by budget and staff reductions, fusses over testing of drugs to combat AIDS, second- guessing over poisoned Chilean grapes, corrupt employees and controversies over the nutritional claims adorning food packages...
...result, the agency has a bad case of bureaucratic burnout. Approval of new drugs requires mountains of corporate filings, and delays in processing applications now run well over two years. That has led to more scandal: this summer investigators discovered that a few generic-drug developers had bribed underpaid FDA employees to speed up the agency's responses to the paperwork for their products. Three FDA reviewers have already pleaded guilty, and more prosecutions are expected. "This past year has been one of the most difficult in FDA's history," said Commissioner Frank Young last week...
Last week Sullivan went further by announcing the creation of a blue-ribbon commission to get the FDA back on course. "The President and I are committed to strengthening the FDA," Sullivan declared. In the Senate, meantime, Massachusetts liberal Edward Kennedy has joined with Utah conservative Orrin Hatch in a bipartisan effort to beef up the FDA's anemic annual budget by setting a floor level of $500 million, vs. the current total of $492 million. Their proposal would also provide the FDA with a single facility -- currently, it is spread across 22 buildings in Washington, from converted chicken coops...
...Ellen Cooper, a Federal Drug Administration (FDA) official, said that while "no one argues against the principle of individual autonomy," her organization must consider certain ethical and scientific realities before it can make experimental drugs widely available...
Cooper said that when the FDA reviews applications by drug companies to test and develop new drugs, the government organization tolerates more risk with AIDS drugs than for other newly-developed medications...