Word: fda
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Dates: during 1970-1979
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Complains Allen Fox, an aide to Senator Edward Kennedy's subcommittee on health resources and scientific research: "There is no accountability in decision making. The FDA must be reorganized internally." Dr. Sidney Wolfe, director of the Ralph Nader-affiliated Public Citizen's Health Research Group in Washington, says of the agency's initial decision to ban saccharin altogether: "The FDA wrote up its intention in one hour and 20 minutes. The furor could have been avoided if they thought of public reaction. They blew...
Morale at the FDA is frequently bad these days, and senior positions can be hard to fill. Example: Commissioner Kennedy, a biologist, took over last month, a full three months after the resignation of his predecessor, Dr. Alexander Schmidt. In addition, Schmidt had given five months' notice of his intent to leave. Acknowledges Kennedy, who has developed a crash-course understanding of the FDA's problems: "I am learning that the agency does little that is not controversial...
Consumerist Appeal. One reason is the burgeoning scope of the FDA'S activities. The agency's budget has ballooned from $5 million in 1955 to $279 million this year. Its 7,000 employees, half of them scattered through 17 locations around Washington, are charged with regulating a staggering $200 billion worth of goods yearly. Its powers have grown steadily ever since the agency was founded in 1907 under crusading Pure-Food Advocate Harvey Wiley, chief chemist of the Department of Agriculture. In 1938, after 107 people died from use of a sulfanilamide preparation that was supposed...
...FDA's power expanded even further because of the Delaney clause and the lobbying efforts of the late Senator Estes Kefauver. The Senator, an early appreciator of the political appeal of consumerism, pushed through legislation allowing the FDA to ban drugs unless they could be proved effective as well as safe. Thus the agency became involved in preventing possible products from reaching the market, as well as demanding the withdrawal of hazardous ones. Since 1962 the FDA has kept more than 6,500 prescription drugs off the market because their effectiveness could not be demonstrated. The number of over...
Boosters can sum up the agency's merits in one word: thalidomide. In 1961-62, the stubborn skepticism of FDA Pharmacologist Dr. Frances Kelsey kept that tranquilizer from sale in the U.S.-though it was marketed in Europe and Canada, where its use by pregnant women led to the birth of many deformed babies. Critics, however, can cite another name from the same period: MER29. The FDA approved that anticholesterol drug for use, then rescinded the decision when some people who took it developed cataracts...