Patient/Doctor Choice Will End FDA Monopoly

Published June 20, 2007

Dear Editor:

Scott Gottlieb justifiably yearns for a return to patient/doctor control of medical treatment. His June 19 article, “Uncle Sam, M.D.,” points out the fundamental problem with FDA. Its one-size-fits-all regulatory monopoly ignores the plain fact that people have a wide range of health conditions and preferences for risk taking.

There is a common-sense solution to uprooting FDA’s monopoly and making a U turn on the road that has led us to Uncle Sam, M.D. It is called Dual Tracking.

In Dual Tracking, experimental drugs would be put on two tracks. One track is the status quo: FDA clinical testing where patients can easily wait for a decade of testing before gaining access to approved drugs. The other, new, free-to-choose track enables patients and their doctors, after Phase I safety trials are successfully completed, to make informed decisions about the use of not-yet-FDA-approved drugs.

Getting back to patient/doctor control via a Dual Track system is explained in a recent Heartland Institute booklet I authored, “More Choices, Better Health–Free to Choose Experimental Drugs” (available at no charge on my Web site:

Bart Madden ([email protected]) is an independent researcher in Naperville, Illinois and a policy advisor for The Heartland Institute.