Word: fda
(lookup in dictionary)
(lookup stats)
Dates: during 1990-1999
Sort By: most recent first
(reverse)
...crucial elements missing from this image. One of them is that Mrs. Dole's heroic restructuring campaign was largely forced on her by the U.S. Food and Drug Administration after its inspectors found the Red Cross to possess dangerously little control over its blood operations. Another is that the FDA became so fed up with the lack of progress in the first two years of her administration that the agency went to federal court to compel the Red Cross to clean up its act. In this juxtaposition of spin and reality lies an example of the image-burnishing skills that...
...people go in ahead of me and look at what the challenges were going to be." Indeed, she encountered a deeply troubled organization--far more troubled, according to a source close to Mrs. Dole, than she appreciated. Since the mid 1980s, in response to the onslaught of AIDS, the FDA had begun to toughen its inspection of blood banks. In the process, its field inspectors found widespread and potentially dangerous problems with the way the Red Cross tracked blood donors and tested blood for infectious agents. In 1988, under FDA pressure, the Red Cross agreed to assert tighter control...
Despite glowing reports from the Red Cross press office, however, the problems cited by the FDA persisted. In fact the agency's concerns intensified, peaking when an inspection of the Red Cross's national headquarters found that officials still had little control over their nationwide operation. Says James Simmons, director of the FDA's biologics compliance office: "There simply was not a lot of evidence of changes or improvements." Two years into Mrs. Dole's presidency, the FDA, still frustrated, went to court to force the Red Cross to act. The result was a May 1993 consent decree setting...
Resolutely positive, Mrs. Dole says the FDA sought the consent decree merely as a yardstick to measure improvement. She was so prepared for this conversation with TIME that she read aloud remarks by Health and Human Services Secretary Donna Shalala and FDA commissioner David Kessler praising her management. The consent decree, she says, "literally was a ratification, it was a ratification of what we were doing...
...Even though six years ago the FDA warned physicians that certain drug combinations can cause life-threatening side-effects, the antihistamine SELDANE is still prescribed for 1 in 50 patients along with such antibiotics as erythromycin and clarithromycin and antifungals like ketoconazole...