Over the past century, American consumers have benefited from thousands of new pharmaceuticals and medical devices to help them combat disease, alleviate the symptoms of illness and infirmity, and improve their well-being. However, the public often demands that such treatments meet a near-perfect level of safety at bargain basement prices. In turn, Congress and the federal Food and Drug Administration (FDA) have steadily raised the regulatory hurdles that medical product manufacturers must clear before they can market a new treatment.
A strong dose of over-caution when the FDA approves new drugs and devices may sound like a virtue, but for patients in need of new treatments, regulatory over-caution can be deadly. Patients can be injured if the FDA approves a treatment that is later found to be unsafe, but they are also harmed when needed