Word: fda
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Dates: during 1990-1999
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...Bush Administration might even be persuaded to go along with this extra regulatory step. For several years now, it has been pressuring the FDA to streamline its approval process. Agency officials have been reluctant, and the recent scandals have proved them right. But streamlining approval may make more sense if postapproval surveillance is beefed...
Brave words from a bureaucrat with limited power. Although the FDA is entrusted with guaranteeing the safety of all medical drugs and devices in the U.S., it is poorly armed for the job. For example, unlike almost every other federal agency, the FDA lacks the legal clout to subpoena a company's internal records if a problem is suspected. Congress woke up to the problem last fall, at Kessler's prodding, and introduced a bill that would have enabled the ( agency to seize corporate documents. The threat of a presidential veto halted the measure, though the new revelations about Halcion...
...drugs scandals of the '90s are prompting other calls for heightened regulation. One proposal, currently making its way through Congress, would give the FDA commissioner emergency powers to pull any drug from the market. At present, about all he can do is jawbone a recalcitrant company into withdrawing a dangerous product. "It's easier for the Consumer Products Safety Division to recall a toaster than for the commissioner of the FDA to recall a dangerous drug," grouses a Capitol Hill staff member. Even so, the measure is strenuously opposed by both the Pharmaceutical Manufacturers Association and the White House, which...
Would-be reformers are also pushing the FDA to adopt a more strenuous review of drugs after they have been approved for marketing. Such postapproval monitoring is already being tried in Canada, Britain and Sweden, where officials can tap into data from a national health-care system. The reasoning behind the push is quite straightforward. Clinical trials typically include a few thousand people and can therefore pick up only the most obvious and prevalent side effects. Once a drug enters the market, hundreds of thousands or even millions of people start using it, often for sustained periods of time -- when...
Currently the FDA relies on spontaneous reporting of postmarketing problems by physicians who prescribe the drugs or manufacturers who may receive complaints from doctors. It is a seriously flawed system, says Joe Graedon, author of several consumer-oriented books about prescription drugs. First, says Graedon, if a patient has a problem -- say an upset stomach or itching skin -- he or she may not make the connection to a drug or medical device. Second, even if the patient does make the link, the doctor may dismiss it. Third, a physician simply may not take the time to report a suspicious problem...