Inside the FDA: The Business and Politics Behind the Drugs We Take and the Food We Eat (Hardcover)

~ (Author) "Garo Armen, Russ Herndon, Pramod Srivastava, and Renu Gupta started practicing at nine in the morning on the day after Labor Day, 2003..." (more)
Key Phrases: pharmaceutical officials, clinical hold, drug ads, United States, White House, New York (more...)

Editorial Reviews

Product Description

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).

From the Inside Flap

"Americans count on this agency to make sure that we have a steady stream of wonderful new pills that are potent and perfectly safe at the same time, as well as a supermarket full of goodies we can gobble up without worrying about food poisoning."
—From the Introduction

Because of the importance of what it regulates, the FDA comes under tremendous pressure from powerful food and drug companies, determined consumer groups, and demanding politicians. But the pressure goes far beyond the ordinary lobbying of Washington trade groups. Its mandate—over 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 the price of prescription drugs and the dangers of genetically engineered food, to debates over teenage pregnancy and the role of government itself, Inside the FDA takes you on an intriguing journey into the world of today's most powerful consumer agency. Through scores of interviews with FDA employees and professionals familiar with the FDA, as well as real-world stories, healthcare and business expert Fran Hawthorne shows you how and why this agency makes some of its most controversial decisions. She discusses why the FDA fails to catch the dangers of drugs like Vioxx before they hit the market, and goes behind the story of Martha Stewart and the revolutionary cancer drug Erbitux to show how the FDA's handling of that drug may jeopardize its ability to keep up with future scientific developments.

In a time when companies continue to accuse the FDA of nitpicking and needless paperwork, while consumers complain that the agency bows to industry pressure by prematurely approving risky products, Inside the FDA digs deep to reveal the truth about an agency that affects our daily lives more than any other single entity in the world.

Inside you'll discover:

• How the FDA will face its first case of embryonic stem-cell research
• Why the FDA goes so easy on foods that are genetically engineered
• How dangerous drugs like Vioxx get past the FDA's safety measures
• When off-label prescribing—taking a drug that has been approved only for Condition A and prescribing it for Condition B—is dangerous, and when it may be lifesaving
• Why the FDA let drug ads on TV
• What it's like to launch a biotech firm and try to move a brand-new drug through the FDA
• Why the FDA's role is growing more and more beyond science and into public policy

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 influences it, 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.

See all Editorial Reviews

Product Details

• Hardcover: 338 pages
• Publisher: Wiley; 1 edition (February 25, 2005)
• Language: English
• ISBN-10: 0471610917
• ISBN-13: 978-0471610915
• Product Dimensions: 9.3 x 6.3 x 1.3 inches
• Shipping Weight: 1.2 pounds (View shipping rates and policies)
• Average Customer Review: 4.6 out of 5 stars  See all reviews (8 customer reviews)
• Amazon.com Sales Rank: #186,128 in Books (See Bestsellers in Books)

Customer Reviews

Most Helpful Customer Reviews

17 of 18 people found the following review helpful:

5.0 out of 5 stars The FDA's job may not be able to be justified, March 14, 2008

By	Guy F. Airey "The Chemist" (San Antonio, TX USA) - See all my reviews

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 little or no reason at all. However, the author does miss one point. If current US law permits the FDA to grant additional time for patent bending and corruption (which it does), do not blame the agency for that. The FDA seems to have gotten too large for its own good. I have asked them why phenylalanine is placed in certain Rx products, and cannot get an answer. The best thing to do with the FDA, if you read this book, is quite obvious. Get rid of the current system. But so many government agencies (like the NTSB and EPA) are operated the same way. There needs to be more public oversight and accountabilitiy, which the author does a great job in exposing. Overall, I would rate this a good book because it exposes this giant agency for exactly what it is: an excercise in extreme loss of objectivity and greed. guyairey

8 of 8 people found the following review helpful:

4.0 out of 5 stars Highly Informative (and Neutral) Look at the FDA, August 8, 2007

By	Andrew Shaffer "www.PrintisUndead.com" (Davenport, Iowa) - See all my reviews (REAL NAME)

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.

13 of 16 people found the following review helpful:

5.0 out of 5 stars Fascinating, Informative Look at Food & Drug Administration, May 27, 2005

By	Kip Piper "Medicare & Medicaid Consultant" (www.KipPiper.com) - See all my reviews

"Inside the FDA" is a thoughtful, balanced, and well-researched look inside the controversial and troubled Food and Drug Administration. Author Fran Hawthorne is an experienced business journalist and her skills are evident here.

Digging into the FDA's complex and conflicting world, the book provides an informative picture of FDA's bureaucratic, political, and scientific drivers. Ms. Hawthorne does an excellent job of laying out what the FDA is suppose to do, what is really does, and where and why it fails.

It makes for a great read.