‘Value’ - the third hurdle to drug acceptance

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Having received approval for a drug, companies now need to assess the additional information requirements that exist in the current environment of cost consciousness. Previously, US companies were only concerned with supplying adequate data on efficacy and tolerability to the FDA, but now there is a demand for cost-effectiveness information that can denote the value of a drug to managed care players. Speakers at the FDA-sponsored meeting ‘Comparing Treatments: Safety, Effectiveness and Cost Effectiveness’ [ Bethesda, US; March 1995 ] discussed these new information requirements, and presented the latest US guidelines on how to conduct relevant studies.