Right Question, Wrong Answer: A Response to Professor Epstein and the “Permititis” Challenge

In this Response to Professor Epstein’s Against Permititis: Why Voluntary Organizations Should Regulate the Use of Cancer Drugs, Professor Hall argues that while he agrees with Professor Epstein’s assessment of the problems with the FDA drug approval process, he disagrees with his proposed solution. Professor Hall argues that Professor Epstein’s solution—to reduce the FDA to an advisory/information role after Phase I testing—devalues the mission of the FDA and has already been rejected by the body politic. Instead, Professor Hall contends that the solution to problems with the FDA drug approval process is to work to improve and optimize the system, not to eliminate it.

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De Novo

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