Would The FDA Reject Itself‪?‬

This book explores the pharmaceutical industry, the U.S. Food and Drug Administration, and the practice of medicine, with an eye toward questioning the assumptions that many people hold.

Like many readers, I grew up believing that government agencies protect us in the same ways that our parents protected us when we were young; they understand the world well, know us well, and put our interests before their own. But later, I began to question that view: why would a huge government agency manned by people who are complete strangers to me care so much about my well-being? Even if those people do care, do they have the right information to make good decisions about my health and welfare? Do they know anything about me? What if my childhood assumptions were wrong?

One day, I started to reconsider the topic of drug regulation with fresh eyes. That thinking led slowly, but directly, to this book. Instead of simply holding the common view that the current form of regulation is optimal, I started from first principles and questioned the common view. The more I thought about the issue, the more I saw both the benefits and the costs of drug regulation. As I continued to think more keenly, the less I saw the benefits and the more I saw the costs. The result of those years of thinking: this book.

This book explores the issues from first principles. What does drug safety mean? What does drug efficacy mean? Is the FDA scientific? Why do pharmaceutical and biotechnology companies develop new drugs? What could stop them? What could help them? What is the FDA’s role in this? How do patients and their physicians make therapy decisions? Do they share goals with the FDA? What health risks do American face? Why and how do bad drugs enter the market? How did the FDA come about? Would Americans be better off with the current FDA, a revised FDA, or no FDA at all? What laws could be changed to improve the situation?

It's true that I’m an industry insider. But don’t for a minute think that I’m an industry shill. This book doesn’t repeat industry perspectives; it challenges them.