Published Online: Thursday, February 1, 2007

The FDA?s proposed regulatory changes will expand the availability of experimental drugs. The change also will clarify the circumstances and the costs for which a manufacturer can charge for an investigational drug.

Under the proposed rule, broader access for experimental drugs would be available to individual patients, small patient groups, and larger populations under a treatment plan when there is no satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.

The most significant proposals would (1) modernize applicable regulations to include all circumstances under which access to experimental drugs is permitted; (2) make experimental drugs more widely available in appropriate situations by creating criteria that link the level of evidence needed to support the use of an experimental drug to the seriousness of the disease and the number of patients likely to be treated with the drugs; and (3) revise the current regulation regarding manufacturers? recoupment of costs of an experimental drug.

The latter rule will clarify the charges that are permissible in a clinical trial only to facilitate development of drugs that promise major advantages over existing therapies. The change also will make clear that allowing for treatment the use of an experimental drug is intended to assist and encourage access to drugs that might not be available for treatment use unless a manufacturer is able to recover its costs.

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