Breaking the Fda Monopoly

Abstract

I propose to end the FDA monopoly on market access to drugs and medical devices. I believe a "second track" could be opened for consumers to access those products - a track that would allow informed consumers to purchase drugs that have undergone only the first phase of the three-phase FDA drug-approval process. By opening this second track, patients would have access to potential miracle drugs after those drugs have passed their Phase I safety tests, while the FDA could continue the Phases II and III tests that examine the drug's efficiency.

Keywords: FDA, Food and Drug Administration, health, medicine, drug-approval, prescription drugs, health care, health care market, clinical trials

JEL Classification: O38, I11, I18