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

Fran Hawthorne (Author)

Book Description

Publication Date: February 25, 2005

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).

Editorial Reviews

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

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: 6.3 x 1.3 x 9.2 inches
• Shipping Weight: 1.2 pounds (View shipping rates and policies)
• Average Customer Review: 4.4 out of 5 stars  See all reviews (10 customer reviews)
• Amazon Best Sellers Rank: #383,788 in Books (See Top 100 in Books)

More About the Author

Award-winning journalist Fran Hawthorne, the author of "Ethical Chic: The Inside Story of the Companies we Think We Love" (Beacon Press, 2012), has been a writer or editor at Fortune, BusinessWeek, Institutional Investor, and other publications. She is the author of three books on health care and investing, including Inside the FDA and Pension Dumping.

Photographer Copyright Credit Name: Leonard Yakir, 2012.

Most Helpful Customer Reviews

14 of 15 people found the following review helpful

5.0 out of 5 stars Everything you want to know about the FDA. August 28, 2008

By Gaetan Lion TOP 1000 REVIEWER

Format:Hardcover

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 else than its main purpose (off-label use), the FDA has no say on that. We are on our own. Also, supplements are not regulated by the FDA. You buy a supplement from China that has some lead in it. You do so at your own risk. Also, the FDA clinical trials will not catch side effects that occur less than 1% of the time. So, they approve drugs that are perfectly safe for 99% of the population but can turn out to be lethal to 1%. That's what happened with Vioxx. It passed all the rigorous clinical trials. But, when the population at large took it a very small percentage suffered dire cardiovascular implications. So, expect nasty headlines and drug recalls to continue because there is no explicit alternative to their occurrences.

No matter how you look at it, the FDA is under a huge amount of political pressure. Unlike the Federal Reserve they are not an independent branch of government. Their livelihood (Budget) is almost solely dependent on the goodwill of Congress. And, Big Pharma lobbies Congress to death. Thus, the FDA is always under huge pressure to do the right thing by its boss, Congress, who in turn does the right thing by its customer-constituent Big Pharma. Exacerbating those conflicts of interests even more, now a good part of the FDA's budget is financed by fees approved by Congress it earns directly from Big Pharma. This is the exact same conflict of interest that caused the housing and credit crisis. Moody's and S&P gave AAA ratings to mortgage securities that should have been rated BB at best in part because the rating agencies are paid by the security issuers. Fortunately, consumer groups and related liabilities mount a counter pressure to Big Pharma that forces the FDA to maintain its proper balancing act.

The author taught me a bunch of things I did not know about this whole business. Some are downright funny. I always wondered about drug advertising on TV. Remember when we were bombarded by drug TV commercials and the commercial did not even tell you what the drug was for. It just told you to ask your doctor about a specific drug. We probably all thought this was really absurd. Now I know it was at the time the FDA's effort to regulate what pharmaceutical companies could say in TV commercials about drug ads. For the FDA it was a way of saying `No' without having the full power to say no. I don't think the FDA thought Big Pharma would take their word for it and produce commercials without saying what their product was for but they did!

In any case, if you want to know everything there is to know about the FDA I strongly recommend this book.

15 of 17 people found the following review helpful

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

By I Hear Vine Voices VINE™ VOICE

Format:Hardcover

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.

20 of 24 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

Format:Hardcover

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