Word: fda
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Dates: during 2000-2009
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...debate begins in earnest this week, when the FDA conducts hearings on requests by Merck & Co., maker of Mevacor, and Bristol-Myers Squibb Co., manufacturer of Pravachol, to sell lower-dose versions of their cholesterol-lowering products over the counter (OTC). If the FDA approves the switch, it may unleash a flood of similar requests from other drugmakers...
Traditionally, nonprescription drugs have been limited to treating mild and temporary conditions like headaches and heartburn. But the FDA is weighing the possibility of letting stores sell medicines that treat symptomless lifetime conditions like high cholesterol and osteoporosis--as many other Western nations do. The agency could go so far as to make birth-control pills and antibiotics as accessible as aspirin. That's too far for some critics, who express concern about our nonchalant, pill-popping approach to medicines. Does anyone even read a label? they...
...change could rock the $100 billion pharmaceutical industry. In the past, the drug companies decided when to ask to make a switch, a situation that critics say merely reinforced their patent protection and high prices. Now the FDA is considering making more decisions on its own, and the consequences could be enormous, affecting who pays for these drugs and how much, just as these issues are becoming politically explosive. The move could shift some costs that insurers now pay for drugs to consumers--although at least there would be no forms to fill...
Consider Claritin, the world's best-selling allergy drug, which is sold OTC in many nations. It costs about $17 a month in Canada. But in the U.S., Claritin requires a prescription and carries a $62 price tag. That's why Blue Cross of California has asked the FDA to shift Claritin to OTC status. But Schering-Plough, manufacturer of Claritin, sold $2.7 billion worth of the drug last year, 85% of which came from U.S. sales. Rx is O.K. for Schering...
...newest alternative to HRT has won FDA approval, but for a different condition. It's a drug called gabapentin, okayed in 1993 to treat seizures but commonly used for relief from migraines and chronic pain. In a study of five women taking gabapentin, neurologist Thomas Guttuso Jr. of the University of Rochester reported an 87% reduction in hot-flash frequency. But Guttuso admits his study is too small to be more than just an interesting first step. Besides, gabapentin can have unpleasant side effects; patients taking it have complained of feeling sedated...