Word: fda
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Dates: during 1980-1989
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Last week the FDA got a chance to play hero when it announced a streamlined procedure that could cut the time it takes to develop and market a new drug from eight to as little as three years. The new rules will affect only medications designed to treat seriously debilitating or life-threatening illnesses such as AIDS, some forms of cancer and Alzheimer's disease. Moreover, the regulations will probably disappoint many people because it will still take years for most drugs to pass through the agency's approval pipeline...
Greater cooperation between the FDA and pharmaceutical companies is the key to the new plan. Before a drug can be approved in the U.S., its manufacturer must guide it through a gauntlet of testing, moving from basic laboratory experiments through animal research to carefully controlled experimentation on people. Under the system in use until now, FDA investigators did not begin evaluating the evidence until the human trials were almost finished. If the research methods or the results did not meet FDA requirements, pharmaceutical companies had to perform more testing, sometimes starting all over again. Now manufacturers...
...FDA move has met with mixed reviews. Critics charge that the announcement amounts to a political ploy by the Reagan Administration to make George Bush look good three weeks before the election. How? Bush chaired the Presidential Task Force on Regulatory Relief this summer, which suggested that the FDA could make the drug-approval process easier and faster. The Pharmaceutical Manufacturers Association, on the other hand, announced its support for the agency's plan, and industry analysts predicted that as many as twelve experimental drugs could be evaluated under the new schedule over the next year...
This is not the first time the FDA has unveiled a streamlined approval process. In 1982 the agency announced several timesaving steps, including a call for better communications between the FDA and manufacturers. Last year, after vociferous protests from people suffering from AIDS, the agency established a fast track for drugs that might help in the fight against the eight-year-old epidemic. So far, however, only one very expensive medication, which can cause severe anemia, has been approved -- Burroughs Wellcome's Zidovudine...
...private seal of purity may become a standard feature in supermarkets because the FDA is considering a policy that would require growers and retailers to take over much of the responsibility for testing their produce. Some grocers believe that higher food prices would result. But many experts contend that more widespread testing would encourage growers to use fewer pesticides -- even if it means that their produce will be slightly less perfect-looking...