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Inside the FDA: The Business and Politics Behind the Drugs We Take and the Food We Eat Hardcover – February 25, 2005

4.3 out of 5 stars 12 customer reviews

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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


"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


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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: 1.6 pounds (View shipping rates and policies)
  • Average Customer Review: 4.3 out of 5 stars  See all reviews (12 customer reviews)
  • Amazon Best Sellers Rank: #355,273 in Books (See Top 100 in Books)

Customer Reviews

Top Customer Reviews

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.
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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
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Format: Hardcover
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.
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Format: Hardcover
Far better and more balanced than any book to date on the subject. The book does an amazing job explaining the external forces tugging in all directions at the FDA without those shrill calls for "reform" made by so-called public interests like CSPI or misguided lawmakers like Hinchey out of NY.

The only thing missing from the analysis are the internal forces. FDA attitudes are very much related to the belief system of the staff and the culture fostered by the institution.

If you've ever been on the receiving end of an FDA action, you know the prevailing culture inside the FDA views the entire industry as the police view criminals. The FDA often seems to doubt every iota of data, question every motive and act as if the administrative procedures which insure fairness are somehow boundaries on a power they believe should be limitless. Many parts of the FDA are an "end-justifies-the-means" culture. Staff who don't toe the line and approach industry with all out animosity and suspicion are often suspect themselves of being deficient in intellect and/or integrity.

The book does a bang up job analyzing external forces. If Ms. Hawthorne actually could have gotten inside the front lines at FDA, she would have had all the facts she needed for a superb analysis.
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