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FDA Approval of New Drugs

August 04, 1996

In his July 22 commentary, Sidney Wolfe called FDA approval the world's "gold standard." But Wolfe has struck only fool's gold.

Practicing American doctors (who are the real experts in this debate) emphatically disagree with Wolfe. Far from considering FDA an indispensable safety check, they see it as a hindrance in their work to save lives. In a recent poll, 71% of cardiologists said that FDA regulation had compromised their ability to treat their patients, and 65% of cardiologists said the agency is too slow to approve new drugs and devices. The heart specialty is not alone in their recognition of FDA's sluggishness; in another poll 77% of oncologists agreed FDA approval is too slow.

Wolfe's opposition to unapproved uses of approved drugs amounts to an attempt to prevent doctors from adequately treating their patients. Off-label drug use is already widespread (and vitally important) in most fields because of the crippling delays unposed by FDA's drug approval process. In cancer chemotherapy, for example, over 60% of prescriptions are off-label. Indeed, some courts have ruled that it can be malpractice for a doctor not to make off-label prescriptions in some circumstances.


Competitive Enterprise Institute


* Thousands die annually, waiting for FDA approval of drugs in use for years in other countries.

The legislation to apply some common sense to FDA drug approvals is no more than a modest reform, highly desirable, and probably not nearly far enough. But it is a fine first step.


La Puente

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