Word: fda
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Dates: during 1990-1999
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...panel said Rezulin should stay in circulation: the dangers are real, but they're outweighed by the drug's lifesaving potential. But even if the FDA goes along with the decision--which it need not but generally does--the very fact that the meeting took place raised questions about the agency's approval process. Rezulin got its thumbs-up via the so-called fast-track system, which slashes through some of the FDA's red tape in order to get an important medication into patients' hands quickly. Drug companies love it, since it gets profits rolling in sooner...
Critics insist that the fast track cuts back on not just bureaucracy but safety too. The FDA has always insisted that any shortcuts it takes are balanced by the tight monitoring of fast-track drugs once they're in use. But in this case, at least, the monitoring was badly inadequate. The panel learned, for example, that 200,000 patients have taken Rezulin for a year or more--or maybe it's 400,000. No one could say if the risk leveled off after six months or kept growing. No one knew if the 35 deaths represented all those...
...used safely for more than 40 years. They have been subjected to decades of testing, and they have consistently delivered reliable service under the most demanding conditions, such as cardiac surgery, blood transfusions and kidney dialysis. You should have quoted the Food and Drug Administration on this issue. The FDA does not see this as a matter of pressing concern, nor do many other medical authorities whose views were not included in this piece. MARK A. SOFMAN MANAGER OF INDUSTRY AFFAIRS Vinyl Institute Washington...
...lower-cost drugs. Last year the company helped found a lobbying group called the Campaign for Fair Pharmaceutical Competition. The group is currently pushing to eliminate sections of the Waxman-Hatch Act, a landmark 1984 law designed to promote drug competition. One target: a provision that prevents the FDA from reviewing generic-drug applications for 30 months if the patent holder sues...
...FDA rejects new flu-drug inhaler...