To America's Health: A Proposal to Reform the Food and Drug Administration (Hoover Institution Press Publication, 482)

A government monopoly over drug regulation is not sacrosanct. This hard-hitting book describes the current regulation of drugs by the FDA and proposes a model for fundamental, yet workable, reform—including an innovative proposal for drug testing and certification review.

A government monopoly over drug regulation is not sacrosanct. In fact, federal oversight-which vitally affects the availability of drugs to patients in need-is in shambles. The regulatory monopoly of the federal Food and Drug Administration has become, literally, overkill and actually threatens public health. Regulatory reform that introduces competition and incentives to get safe, effective drugs to patients can, however, transform the drug development process and reverse the current upward spiral of time and costs. The public will benefit directly by earlier access to greater numbers of less costly drugs and indirectly by greater robustness and productivity in the pharmaceutical industry.

This hard hitting book describes the current regulation of drugs by the FDA and proposes a model for fundamental yet workable reform, including an innovative proposal for drug testing and certification review Medical technology has advanced at a stunning pace in the past half century, enabling drug and biotechnology companies to become major contributors of innovative life--saving and life-enhancing medicines.