Policy Documents

A Clinical Trial for the FDA's Clinical Trial Process

Bartley J. Madden –
November 6, 2005

The FDA is responsibile for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation.  The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate,, science-based information they need to use medicines and foods to improve their health.

We argue that FDA control over drugs and devices has large and often overlooked costs that almost certainly exceed the benefits.  We believe that the FDA regulation of the medical industry has suppressed and delayed new drugs and devices, and has increased costs, with a net result of more morbidity and mortality.  A large body of academic research has investigated the FDA and with unusual consensus has reached the same conclusion.