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

—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.

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).

"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

Introduction.

Chapter One: Case Study - Chasing Cancer.

Chapter Two: Beyond Science.

Chapter Three: The First 100 Years.

Chapter Four: “You Don’t Know Which Agency Is in Charge”.

Chapter Five: Truckloads of Paper.

Chapter Six: Case Study – The Return of Thalidomide.

Chapter Seven: How Picky Is the FDA?

Chapter Eight: How Powerful Is Industry?

Chapter Nine: Case Study — The Death of Monica George.

Chapter Ten: When Consumers Get Angry.

Chapter Eleven: A Political Pawn.

Chapter Twelve: FDA and DNA.

Chapter Thirteen: The FDA Meets Madison Avenue. 

Chapter Fourteen: Frivolous Drugs?

Chapter Fifteen: The Next 100 Years.

Endnotes.