Free to Choose Medicine-Better Drugs, Sooner, at Lower Cost

Abstract

This paper is a chapter in my forthcoming book, Value Creation Insights, that focuses on systems thinking as an integral part of knowledge building and value creation. The Free To Choose Medicine (FTCM) approach to FDA reform argues that from a societal perspective, the proper goal of the FDA regulatory system should not be safe and effective drugs, which has led to a relentless increase in the costs (time and money) to secure FDA approvals. Rather, the system goal should be better drugs, sooner, at lower cost, which could be achieved via FTCM that would enable informed access to not-yet-fully-approved drugs that have passed initial safety and efficacy trials. The benefits from FTCM are analyzed including comparisons to the FDA's compassionate use, Right To Try signed by Trump in his first term, conditional approval passed by Japan for regenerative medicine drugs, and the Promising Pathway Act that is about to be reintroduced into Congress and would implement FTCM principles for rare and life-threatening diseases.

Keywords: FDA reform, Free To Choose Medicine, systems thinking, Promising Pathway Act

JEL Classification: I11, I18, L51, M21, O35