Breaking the Fda Monopoly

3 Pages Posted: 25 Jul 2004


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

Suggested Citation

Madden, Bartley J., Breaking the Fda Monopoly. Available at SSRN:

Bartley J. Madden (Contact Author)

Bartley J. Madden Foundation ( email )

PO Box 110699
Naples, FL 34108
United States

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