14 Pages Posted: 19 Sep 2017
Date Written: September 16, 2017
For over a decade, I have been promoting a Free To Choose Medicine (FTCM) initiative in op-eds, journal articles, interviews, and monographs. FTCM would break the FDA’s monopoly on access to new drugs. It would enable patients, advised by their doctors, to make informed decisions about using promising not-yet-approved drugs that have successfully passed FDA Phase I safety trials and one or more Phase II trials. I believe the timing is finally right for bipartisan support of FTCM. For example, there is growing awareness that the FDA is rooted in an excessively expensive (time and money) clinical testing paradigm that results in sky-high drug prices and delayed access to the most innovative new drugs. The new head of the FDA is Dr. Scott Gottlieb who appreciates the benefits of competition and wants to fundamentally improve the FDA. There is huge public support for Right To Try state legislation that would enable patients to circumvent the FDA for life-threatening illnesses. Importantly, FTCM can no longer be pigeonholed as an abstract concept—it is a practical solution to achieving better drugs, sooner, at lower cost, as being demonstrated in Japan. An early booklet about FTCM was translated into Japanese and played a significant role in passage of FTCM legislation in Japan for regenerative medicine drugs—see slides 9, 10, and 11 of this PowerPoint presentation. Also, slide 8 references a Scienceblogs.com post criticizing FTCM and my reply to this criticism.
Keywords: Free To Choose Medicine, FDA reform, competition, consumer choice
JEL Classification: A13, D3, D81, E61, H11, I11, I18, L51
Suggested Citation: Suggested Citation
Madden, Bartley J., Free to Choose Medicine: Powerpoint Presentation (September 16, 2017). Available at SSRN: https://ssrn.com/abstract=3038163