Inside the FDA: The Business and Politics Behind the Drugs We Take and the Food We Eat
The forces that shape America's most powerful consumer agency Because of the importance of what it regulates, the FDA comes under tremendous political, industry, and consumer pressure. But the pressure goes far beyond the ordinary lobbying of Washington trade groups. Its mandate-one quarter of the national economy-brings the FDA into the middle of some of the most important and contentious issues of modern society. From "designer" babies and abortion to the price of prescription drugs and the role of government itself, Inside the FDA takes readers on an intriguing journey into the world of today's most powerful consumer agency. In a time when companies continue to accuse the FDA of nitpicking and needlessly delaying needed new drugs, and consumers are convinced that the agency bends to industry pressure by rushing unsafe drugs to market, Inside the FDA digs deep to reveal the truth. Through scores of interviews and real-world stories, Hawthorne also shows how and why the agency makes some of its most controversial decisions as well as how its recent reaction to certain issues-including the revolutionary cancer drug Erbitux, stem cell research, and bioengineering of food-may jeopardize its ability to keep up with future scientific developments. Inside the FDA takes a closer look at the practices, people, and politics of this crucial watchdog in light of the competing pressures and trends of modern society, revealing what the FDA is supposed to do, what it actually does-and fails to do-who it influences, and how it could better fulfill its mandate. The decisions that the FDA makes are literally life and death. Inside the FDA provides a sophisticated account of how this vitally important agency struggles to balance bureaucracy and politics with its overriding mission to promote the country's health. Fran Hawthorne (New York, NY) is a senior contributing editor of Institutional Investor and has connections deep within the business and finance communities. Hawthorne has been covering healthcare and business for more than twenty years for such publications as Fortune, BusinessWeek, and Crain's New York Business. She is the author of The Merck Druggernaut (cloth: 0-471-22878-8; paper: 0-471-67906-2).
Everything you want to know about the FDA.
By Gaetan Lion - August 28, 2008
This is one of the most thorough investigative books I have ever read on such a narrow topic. The author covers the history, and political and regulatory issues of the FDA in far more detail than I expected. Her in depth investigative style reminds me of Sylvia Nasar in A Beautiful Mind: The Life of Mathematical Genius and Nobel Laureate John Nash.
From the author's investigation I derived the FDA does the very best of an impossible situation. This is because its constituents have irreconcilable contradictory objectives. Big Pharma wants fast and efficient drug approvals. Consumers want safe drugs in all circumstances. Congress wants a cheap regulatory process (fiscal efficiency).
I also realize that despite their best efforts the FDA can't keep us safe. This is true for several reasons. The FDA does not control how doctors prescribe drugs. When they prescribe a drug for something... read more
Highly Informative (and Neutral) Look at the FDA
By I Hear Vine Voices - August 8, 2007
Democrats want more Big Pharma regulation and consumer protection. Republicans want to protect Big Pharma's profits. The tobacco and diet supplement industries want to be left the hell alone. And consumers want miracle drugs for free. Somehow, some way, the FDA navigates the minefields of the food and drug industries every day and tries to base its decisions on science. While some authors take cracks at the FDA because of a political agenda, Fran Hawthorne remains neutral and thus provides the most level-headed look at the FDA that's on the shelves. While the reading is pretty dense, this is a book that every concerned citizen needs to read.
The FDA's job may not be able to be justified
By Guy F. Airey "The Chemist" - March 14, 2008
Rarely do any of us get a glimpse so throughout into a governmental body as large as the FDA. Author Fran Hawthorne claims the FDA to have nearly 11,000 doctors, scientists, and others --all there to maintain the safety of the drugs all Americans use and do a good job of it. I think they have been lucky. They (the FDA) has lost its objectivity over the years because of a counter productive lifestyle. They have panels voting on issues or problems with drugs on the markets of which the voting members often have stock in the very company which is being checked. They allow advertising of rx products on TV, a practice only permitted by one other country in the world..and a very bad practice. Money, has replaced their objectivity because they have become big friends to the pharmaceutical companies, especially the larger ones. CDER, one part of the FDA, even though on the outside pretends to play fair, will often intimidate smaller drug (generic companies) for apparently... read more