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).

Product Details

• Amazon Sales Rank: #395897 in Books
• Published on: 2005-02-25
• Original language: English
• Number of items: 1
• Binding: Hardcover
• 338 pages

Features

• ISBN13: 9780471610915
• Condition: NEW
• Notes: Brand New from Publisher. No Remainder Mark.
• Click here to view our Condition Guide and Shipping Prices

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.

From the Back Cover
Praise For INSIDE THE FDA

"A clear-eyed, thoughtful look at an agency that regulates a quarter of the U.S. economy and, more than any other, has the safety of the American public in its hands. Inside the FDA makes plain how powerful and controversial the Food and Drug Administration has become. People seeking to understand the government's role in health care and the biotech revolution would be wise to read Ms. Hawthorne's book."
—Elizabeth MacBride Health-care writer and former managing editor of Crain's New York Business

"Controversy lives on the FDA's doorstep, and it knocks loudly— as it did recently with Vioxx—when a drug it approves is involved in consumer deaths. Fran Hawthorne has written a vivid and compelling account of the pressures from politicians, industry, and consumers; the scientific uncertainties; the risk-reward compromises; and the constantly changing legal landscape that influences the agency's life-and-death decisions. Since these pressures are not likely to diminish, it is all but inevitable that another Vioxx will slip past the scientists of this powerful, public-spirited but imperfect institution."
—Clem Morgello Former senior editor and columnist at Newsweek, and former senior editor at Dun's Review

Praise for The Merck Druggernaut

"[Hawthorne] understands and communicates the incredible complexity of discovering new drugs and introducing them to the market."
—The New York Times

About the Author
FRAN HAWTHORNE is Senior Contributing Editor of Institutional Investor and has connections deep within the business and finance communities. Hawthorne has been covering health care and business for more than twenty years for Fortune, Crain's New York Business, and other publications, and she now writes regularly for such newspapers and magazines as the New York Times, Worth, and Self. She is the author of The Merck Druggernaut, which is also published by Wiley.

Customer Reviews

The FDA's job may not be able to be justified
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

Highly Informative (and Neutral) Look at the FDA
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.

Interesting look at an important regulatory body
For those who have ever wondered how the FDA makes decisions and how those decisions effect companies this is a great starting point. Hawthorne takes an objective stance towards the FDA and shows their faults along with the positives. She tracks several instances of FDA oversight and gives their results. I think the part that tracks the companies progress through the FDA's is the most instructive. One of my fields of study was health and pharmaceutical economics and this was a great way to start learning about the FDA.