Word: fda
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...Congress is breaking down the barrier. The House last week unanimously passed a bill, almost identical to one already adopted by the Senate, that will speed up approvals of generic drugs by the Food and Drug Administration (FDA). In the past, companies wishing to sell generic versions of drugs marketed after 1962 had to submit detailed scientific studies to demonstrate the pills' safety and effectiveness, even though they were merely copies of medicines already being sold. Under the new law, firms need only show that their generic pills are the chemical equivalents of brand-name drugs and deliver...
That trend should produce dramatic savings for consumers−potentially $1 billion over the next twelve years, according to the FDA. Generic drugs already on the market usually cost much less than their brand-name counterparts. At one Dallas pharmacy last week, customers had to pay $8.79 for 20 tablets of Lomotil, an antidiarrhea pill made by G.D. Searle. But the same amount of medication was available under its generic name, diphenoxylate, for only $3.29. In one New York City drugstore, a medicine for high blood pressure made by Ciba-Geigy called Apresoline cost $15 per 100 tablets; its generic...
There are drawbacks to such an enterprise, of course. The agency could, for example, prevent many technological advances from ever entering the market. Under similar circumstances, the Food and Drug Administration (FDA)'s tight regulation of the drug industry has unquestionably reduced the number of new drugs that hit the market. Until 1974 the FDA had approved, only seven percent of the drugs it tested for marketing, crippling many potentially beneficial advances...
...benefits that accrue from having tight regulation over potentially dangerous technology or drugs far out-weigh the costs--simply by saving lives. The FDA's ban on pressurized aerosol mist in the 1960s significantly reduced the number of asthma deaths in the United States. A high tech regulatory agency would unquestionably produce similar benefits...
...drug works by interfering with the virus' reproductive process. When used as an ointment, however, it merely relieves the discomfort of an initial attack. The FDA is expected to approve the more potent oral form within a few months...