Originally published February 19 2006
New FDA guidelines will allow human testing of drugs to start sooner
by Mike Adams, the Health Ranger, NaturalNews Editor
To compensate for the high failure rate of new drugs, which take a long time to hit the market, the FDA has approved new guidelines that will allow drug manufacturers to introduce small doses of experimental drugs to study participants earlier in the testing process, a move that will allow drug companies to get their products to market sooner, but will endanger many test subjects, according to the measure's critics.
Concerned that too few new drugs are reaching the market and that too much time is spent testing those that ultimately fail to win approval, the Food and Drug Administration on Thursday announced rules for human testing intended to make effective drugs available to the public sooner --- and possibly cheaper.
Under new guidelines, investigators will be allowed to give minute doses of experimental drugs to people earlier in the development process to see if the results are promising enough to warrant going forward with costly, full-scale clinical testing.
Researchers and industry welcomed the FDA action.
But some agency critics said they were concerned it could increase hazards for volunteers in clinical trials or facilitate the approval of drugs before their risks are fully understood.
High failure rate The new system is designed to deal with a problem that not only has slowed getting potentially helpful medicines into patients' hands but also has added billions of dollars in potentially avoidable expenses to the cost of prescription drugs.
Before a new drug can be put on the market, scientists must prove that it is both effective and safe; of the thousands of compounds that researchers test, only a handful ever make it to the pharmacy shelf.
Over the past few years, FDA officials and others have noticed a disturbing pattern: Not only have fewer drugs made it through the required screening, but many of those that ultimately proved unfit for the market were eliminated only near the end of the long development and testing process; they fail to win approval after months or years and after hundreds of thousands --- or sometimes millions --- of dollars have been spent.
Fewer approvals The FDA's new system is designed to help scientists identify sooner the drugs that will turn out to be unmarketable.
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