Word: fda
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Dates: during 1980-1989
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With its meager funds, the FDA is responsible for monitoring 63,000 food firms, 14,000 drug companies, 13,000 medical-device manufacturers and 1,700 cosmetics houses. During the Reagan Administration, cutbacks at the FDA were seen by many probusiness advocates as one important means of unshackling industry. But now, with the number of staffers at the agency down to 7,500 from a 1980 high of 8,100, even business lobbyists are not so sure. "The problems at the FDA stem directly from the deregulatory process," says John Cady, president of the National Food Processors Association. "They just...
...shortfall is worsening. Among other things, Congress reacted to the Reagan cutbacks by passing 23 public health bills during the '80s, many of them efforts to shore up the FDA's powers. The action significantly expanded the FDA's workload. Yet Congress never moved to restore a single lost staff position or add employees to meet the increased responsibilities. The advent of an entirely new industry, biotechnology, demanded an FDA response to more than 950 genetically engineered products during the 1980s...
Popular pressures have also played a role. As AIDS has spread, protesters have charged that the agency has been keeping lifesaving drugs out of the hands of victims. In fact, the FDA spent $5 million more than the $46 million Congress provided to seek a cure for the disease. With health-conscious Americans including less red meat in their diets, the FDA's thin line of inspectors has been forced to monitor increasing amounts of seafood, imported fruits and vegetables, and chicken and eggs. A number of spectacular food- tampering cases, like last March's poisoned Chilean grape case (only...
Decaying labs and desperately low salaries have made hiring another FDA travail. Some important drug-review posts have an annual turnover rate of 20%. At least one former FDA official believes many new employees use their stint at the agency to bolster resumes that are then quickly circulated to industry...
With so many intractable problems facing the FDA, Sullivan's blue-ribbon panel is unlikely to be enough to stop the agency's decay. Says Democratic Congressman John Dingell, chairman of the House Energy and Commerce Committee: "It was an attempt to look like they were doing something, but they aren't and they won't." In an effort to find some creative financing for the FDA, the White House has disclosed that it is considering charging user fees to companies that seek FDA approval for products. The size of the proposed service charges has ranged from an official White...