title: A dual track system to give more-rapid access to new drugs: applying a systems mindset to the US food and drug administration (FDA).
abstract: A widely applicable lesson learned from systems analysis is that a proposed change should always be studied in terms of value to the customer and not a gain in efficiency of any particular component of the system. A systems mindset reveals invalid assumptions that have caused the FDA to substitute its own needs for the needs of its customers (patients). Further, the key constraint to overall system improvement is the lack of consumer choice and competition due to FDA's monopoly over access to drugs. Therefore, we need legislation to implement a proposed dual track system for access to drugs that have successfully passed Phase I safety trials. On one track, an experimental drug would continue with conventional FDA clinical trials. On a new, free-to-choose track, patients, advised by their doctors, would make informed decisions about immediate access to not-yet-approved drugs. Internet access to a government-operated tradeoff evaluation database would provide patients and doctors with up-to-date information on all drug treatment outcomes for both tracks. Dual tracking is a dynamic process that overcomes the limitations of a static FDA regulatory process that ignores individual risk preferences.
authors.forename: Bartley J
authors.initials: BJ
authors.lastname: Madden
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D017277:Drug Approval / Q000379:methods*; D012926:Social Control, Formal / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration