"Extraordinary for its depth, documentation, and originality. In terms of analyzing the current system of drug regulation, making the case for reform, and proposing a remedy, this volume simply dwarfs everything else available on the subject. Most important of all, it really does move us along the path 'To America's Health!'" - Michael H. Mellon, M.D., Associate Clinical Professor, Pediatrics, University of California, San Diego, School of Medicine, La Jolla, CA
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.