In politics, many different rules and regulations create problems for consumers. Regulations that cause people to die - or contribute to their deaths - should bear the highest possible level of scrutiny. In this book, medical doctor and former Food and Drug Administration official Henry Miller addresses problems with the way the FDA reviews and approves new medicines. His analysis is extremely important because, when the government delays the introduction of critical medical innovations, people can die.

The key point in Miller's argument is that imposing excessive regulatory costs on American pharmaceutical firms forces them to experience corporate mergers, reduced competition, and higher prices. In the long run, this leads companies to focus on shorter-term, lower-risk research and development intended for larger patient populations. Thus, smaller groups of patients in need of new medical innovations that require long-term study at higher per-capita costs suffer the most from delays in approving new products.

Miller addresses the myth that there must be a tradeoff between promoting more efficient drug research and improving drug safety. Efficiency and safety can both be improved simultaneously by introducing competition where regulatory oversight has become excessive and changing the FDA's role in the process. Rather than evaluating data itself, it should allow other organizations to evaluate clinical testing and focus on monitoring their efforts instead.

A key problem that many drug manufacturers face is that regulations are not static. When new rules are enacted, regulators generally adopt narrow interpretations of them, but broaden those interpretations as time goes on. Because of this, regulators must be viewed as a special interest group - expanding their turf by skirting congressional oversight and gradually inflating burdens for manufacturers underneath the radar screen.

These problems lead many companies to alter their research priorities. Instead of focusing solely on prospective benefits for consumers when choosing which products to develop, firms must account for potential regulatory costs as well. The high costs of getting drugs approved reduces the diversity of products being prepared - leading many companies to devote more energy to dealing with the regulatory apparatus. Innovation suffers as a result.

The biggest problem with the FDA's current system, though, is its lack of accountability to the public. Consumers cannot participate in its product-review process and cannot obtain judicial review of its decisions. In addition, seldom is information about delayed or rejected drugs and medical devices made available to the media. Thus, the nature of the evaluation process itself reduces consumers' freedom of choice and individual autonomy. It leads many frustrated consumers to travel abroad to obtain safe drugs and services not available here in the U.S.

Fortunately, Miller offers a solution to the problem: allow independent, non-profit drug certifying bodies - instead of the FDA - to review test results from companies. Then allow the FDA to monitor the technical, scientific, and managerial expertise of these bodies to ensure they perform proper reviews. This would be similar to OSHA's accreditation process for testing laboratories. It would also introduce much needed competition, innovation, and efficiency into the oversight process and help alleviate many of the perverse incentives regulators face when interpreting new standards.

Overall, America's drug review procedure is in need of reform. Excessive regulations that lead to increased suffering or death among consumers should be repealed. In addition, when the regulatory process itself delays new technologies or innovations that can reduce suffering or death among the public, the procedure itself should be closely examined. Miller's book sheds new light on a frequently-ignored cost of overregulation: how preventing the adoption of new products or services that save lives can be just as costly as overlooking those that cost lives. His arguments should be given careful consideration by anyone who is concerned about the state of health care in the United States.