To America's Health: A Proposal to Reform the Food and Drug Administration

By Henry I. Miller

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.

• Format: Paperback
• Language: English
• ISBN: 0817999027
• ISBN13: 9780817999025
• Release Date: August 2000
• Publisher: Hoover Institution Press
• Length: 112 Pages
• Weight: 0.45 lbs.
• Dimensions: 0.4" x 6.0" x 9.0"

Customer Reviews

Excellent Look At How Regulations Can Cost Lives

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 dru