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

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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.

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<p>“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.”</p><p><i>—From the Introduction</i></p><p>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. </p><p>From the price of prescription drugs and the dangers of genetically engineered food, to debates over teenage pregnancy and the role of government itself, <i>Inside the FDA</i> 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.</p><p>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, <i>Inside the FDA</i> digs deep to reveal the truth about an agency that affects our daily lives more than any other single entity in the world.</p><p><b>Inside you’ll discover: </b></p><ul><li>How the FDA will face its first case of embryonic stem-cell research</li><li>Why the FDA goes so easy on foods that are genetically engineered</li><li>How dangerous drugs like Vioxx get past the FDA’s safety measures</li><li>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</li><li>Why the FDA let drug ads on TV</li><li>What it’s like to launch a biotech firm and try to move a brand-new drug through the FDA</li><li>Why the FDA’s role is growing more and more beyond science and into public policy</li></ul><p><i>Inside the FDA </i>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. <i>Inside the FDA</i> 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.</p>

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"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.