Pharmacy Times
Volume 0

The FDA?s proposed regulatory changes will expand theavailability of experimental drugs. The change also will clarifythe circumstances and the costs for which a manufacturercan charge for an investigational drug.

Under the proposed rule, broader access for experimentaldrugs would be available to individual patients, smallpatient groups, and larger populations under a treatmentplan when there is no satisfactory alternative therapy todiagnose, monitor, or treat the disease or condition.

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

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

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