Word: fda
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Dates: during 1990-1999
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...plight of women like Jennifer and Amy will not improve until there is an overhaul of federal policy on birth control. The NAS report calls on the FDA to streamline its stringent rules for the approval of new contraceptives. The authors also recommend that pharmaceutical companies be given federal protection from liability suits so that they will be encouraged to get back into the contraceptive business. Unless something is done quickly, the situation for U.S. women may be no better in the 21st century than it is today...
Citing "serious deficiencies" in manufacturing quality, training and other areas, the FDA banned further use of the $22,000 mechanism. Symbion said last week that it will continue to sell the devices outside the U.S. American doctors have alternatives, however, since three other firms now make heart- pumping aids...
...example, won Government approval in less than four months, compared with a current average of two years. Says James Todd, senior vice president of the American Medical Association: "It's distorted all the traditional principles for drug approval. Penicillin couldn't get through that fast." While some modification of FDA regulations may have been necessary, many people believe that the changes being made at the FDA to accommodate AIDS activists threaten a system that has protected the public from quack cures, like the apricot pits once touted for cancer sufferers...
...crisis in 1984 when legislators passed the Waxman-Hatch Drug Act, designed to encourage companies to manufacture more non-brand-name versions of prescription drugs. Pharmaceutical firms may sell these so-called generic drugs only after the brand name has lost its patent protection. The 1984 law streamlined the FDA approval process for generic drugs, reducing the time from an average of three years to a few months. Manufacturer sales of the low-cost drugs thereupon leaped from $3.5 billion in 1984 to $7 billion...
...measure proved to be only a partial solution. Last July a bribery scandal rocked the U.S. industry when three FDA reviewers pleaded guilty to accepting bribes from generic-drug companies. The revelations threw doubt on the efficacy of some generics. Meantime, drug prices continued their upward spiral -- primarily because of the fundamental forces that drive the modern pharmaceutical industry...