Word: fda
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Dates: during 2000-2009
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When the Food and Drug Administration (FDA) issued a warning to consumers on Thursday about E. coli contamination in bagged spinach, it didn't come as a surprise to Michael Doyle. So far, about 100 people have fallen ill and one death has been connected to the dangerous E. coli 0157:H7 bacterial infection, and the director of food safety at the University of Georgia says that outbreaks like this one will only continue if produce manufacturers don't change their practices...
...Cost of a fully implantable artificial heart approved last week by the FDA for use in up to 4,000 people with severe congestive heart failure...
...Both sides of the debate were quick to decry the FDA's ruling as political. "Clearly in this case corners were cut," says Family Research Council health policy analyst Moira Gaul, claiming the FDA overlooked what her group calls a lack of safety evidence. Backers of Plan B, on the other hand, were angered by the FDA's age restrictions on the drug: patients under 18 must still have a prescription to get the drug, even though the FDA's own scientific advisers never recommended such a policy. "They have been playing politics with this issue for 40 months," says...
...Plan B is a synthetic form of progesterone, a hormone commonly used in birth-control pills, and it works by by preventing ovulation, preventing fertilization of the egg, or stopping a fertilized egg from lodging in the uterus. The FDA first approved Plan B, now owned by Delaware's Barr Pharmaceuticals Inc., for use with a prescription in 1999, but the controversy erupted in 2003. That's when FDA officials rejected the recommendation of their scientific advisers and refused to grant Plan B approval for over-the-counter use. The acting director of the Center for Drug Evaluation and Research...
...fact, the FDA considered exactly the same studies when it approved the drug Thursday as it did when it denied the drug over-the-counter sales in 2003. The difference? When Barr resubmitted the application for over-the-counter approval, it limited its request to those patients 16 and older. (A Barr spokeswoman tells TIME it was hard to recruit many girls aged 15 and younger for the kind of studies the FDA wanted, since young teens make up such a small segment of the population needing emergency contraception.) The decision to limit over-the-counter sales to women...