Recently the FDA has become more cautious about approving drugs. In the last few months the agency has rejected a number of experimental drugs or delayed their approval and required extra testing and data.
This change seemed to come after the FDA was criticised for letting risky drugs slip through the cracks and making their way onto the market. The painkiller Vioxx was recalled and there has been a constant debate about whether the diabetes drug Avandia should be pulled because of an increased risk of heart attack.
Chris Milne, associate director of the Tufts Center for the Study of Drug Development, said Friday the FDA has systematically implemented more controls for scrutinizing drugs, particularly for heart and liver side effects. While he thinks the trend on approvals is not yet clear, he said the FDA now is requiring experimental drugs similar to ones already on sale to be more effective and safer than their predecessors.
Some analysts feel that the FDA is being more careful because the agency realizes that patients are using the drugs for off-label purposes, which increases their chances of being harmed by side effects.
The agency has approved only 61 percent of drug applications through mid-August, which is down from 73 percent from the same time last year.
Some patients feel that the agency’s excess caution is keeping important drugs off the market, and that these rejections and delays will increase drug costs and time to develop new medications. But the FDA has said that for drugs where benefits don’t strongly outweigh risks, the agency will err on the side of caution.
For more information on this subject, please refer to our section on Defective and Dangerous Products.
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