Praise for Should the FDA Reject Itself?

The Food and Drug Administration has been front and center during the Covid pandemic. We have heard how it has cut short its usual procedures to speed introduction of promising therapies. But why are its usual procedures so long? Why shouldn’t any promising life-saving therapy qualify for an Emergency Use Authorization? Such questions need to be aired out, and that is what Should the FDA Reject Itself? does.

Sam Peltzman, Ralph & Dorothy Keller Distinguished Service Professor of Economics Emeritus, University of Chicago Booth School of Business

Many assume that, because the FDA was instituted with good intentions and a scientific focus, it successfully discharges its duties and protects Americans from unsafe and ineffective drugs. This book dispels that notion. Hooper sees the many ways that the FDA doesn’t work as intended and, in fact, can’t do what we ask of it. If the FDA isn’t fulfilling its intended purpose, what is it doing? Getting in the way and preventing access to safe, effective, and economical drugs. As with other government programs and agencies, to assess the FDA we must consider the actual benefits and costs, including unintended consequences. This book makes the case that the FDA’s actions have, on net, killed and sickened Americans.

Jeffrey Miron, Senior Lecturer and Director of Undergraduate Studies in the Department of Economics at Harvard University

This hard-hitting book highlights some challenging aspects of the FDA’s regulatory efforts that those of us in the industry have known or suspected for years. Bottom line: things aren’t always what they seem. Whether you earn your livelihood in the pharmaceutical industry, are a doctor, a patient, someone caring for a patient, or just an interested observer, you’ll never look at the drug approval process and the drug industry the same way again after reading this book.

Dan Spiegelman, board member for multiple life science companies; former Executive Vice President & CFO, BioMarin Pharmaceutical

Hooper is the dedicated, capable, humane student of the FDA, fascinated with the workings in detail but ever mindful of the big picture.  With patience and clarity he has written the best book ever written on the FDA.

Daniel Klein, Professor of Economics and JIN Chair at the Mercatus Center, George Mason University

My long-time friend and co-author Charley Hooper makes a strong case for ending the FDA’s monopoly power over drugs. But Should the FDA Reject Itself? does so much more. Hooper gives a fascinating history of vaccine developer Maurice Hilleman, who did much to improve our life expectancies. And he notes that a man whom the FDA calls a criminal is called that because he saved babies’ lives without the FDA’s permission. You will probably learn something important on every page.

David R. Henderson, Research Fellow, Hoover Institution, Stanford University; editor of The Concise Encyclopedia of Economics; and formerly the senior economist for health policy with the President’s Council of Economic Advisers

The FDA’s mistakes and delays during the COVID pandemic alerted the public to the fact that the FDA can be dangerous. Charles Hooper’s breezily written but deadly serious, Should the FDA Reject Itself?, tells us that the problems are old and deep. It’s time to ask whether the FDA is safe and effective. 

Alex Tabarrok, Bartley J. Madden Chair in Economics at the Mercatus Center at George Mason University