Science on FDA Liberalization: A Response to the Status Quo Process for Medical Treatments
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A 2019 article in Science sounds an alarm against moves toward liberalization of drug approval. The authors Douglas Sipp and Margaret Sleeboom-Faulkner deprecate at length the reform proposal of my Free To Choose Medicine, which served as a model for Japan’s legislation authorizing conditional approval for medical treatments focused on regenerative medicine (e.g., stem cells). Sipp and Sleeboom-Faulkner are, I think, wrong in supposing that Japan’s conditional approval will hurt patients by enabling them to gain early access to regenerative medicine treatments. Their article is about 2,900 words in length and appears in an influential journal, so it merits a response. Sipp and Sleeboom-Faulkner suggest that the conventional randomized control trial approach is beyond criticism. However, I argue that reform has the potential to bring large net benefits to humankind. This article—a draft of which was rejected at Science—provides a counterpoint to their opposition to the liberalization.