A recent ScienceBlogs article, “Right To Choose Medicine: The free-market fundamentalist assault on the FDA continues,” is highly critical of the Free To Choose Medicine (FTCM) proposal and my thinking about FDA regulation in particular. The main conclusion is that I must not know anything about science or FDA clinical testing to propose a competitive alternative to the FDA process.
The sensible starting point is to focus on the goal of the drugs-to-patients system. All should be able to agree that the appropriate goal is better drugs, sooner, at lower cost. The FDA is failing to achieve this goal because it has an antiquated system that assumes that you and your doctor are not smart enough to access relevant data and make informed decisions about the use of not-yet-approved drugs, decisions attuned to your unique health conditions and preferences.
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