{"product_id":"inside-the-fda-isbn-9780471610915","title":"Inside the FDA","description":"\u003cb\u003eThe forces that shape America's most powerful consumer agency\u003c\/b\u003e \u003cp\u003eBecause 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.\u003c\/p\u003e \u003cp\u003eIn 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, \u003ci\u003eInside the FDA\u003c\/i\u003e 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.\u003c\/p\u003e \u003cp\u003e\u003ci\u003eInside the FDA\u003c\/i\u003e 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. \u003ci\u003eInside the FDA\u003c\/i\u003e 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.\u003c\/p\u003e \u003cp\u003eIntroduction v\u003c\/p\u003e \u003cp\u003eChapter 1: Case Study: Chasing Cancer 1\u003c\/p\u003e \u003cp\u003eChapter 2: Beyond Science 23\u003c\/p\u003e \u003cp\u003eChapter 3: The First 100 Years 35\u003c\/p\u003e \u003cp\u003eChapter 4: \"You Don't Know Which Agency Is in Charge\" 65\u003c\/p\u003e \u003cp\u003eChapter 5: Truckloads of Paper 79\u003c\/p\u003e \u003cp\u003eChapter 6: Case Study: The Return of Thalidomide 109\u003c\/p\u003e \u003cp\u003eChapter 7: How Picky Is the FDA? 123\u003c\/p\u003e \u003cp\u003eChapter 8: How Powerful Is Industry? 143\u003c\/p\u003e \u003cp\u003eChapter 9: Case Study: The Death of Monica George 179\u003c\/p\u003e \u003cp\u003eChapter 10: When Consumers Get Angry 191\u003c\/p\u003e \u003cp\u003eChapter 11: A Political Pawn 209\u003c\/p\u003e \u003cp\u003eChapter 12: FDA and DNA 233\u003c\/p\u003e \u003cp\u003eChapter 13: The FDA Meets Madison Avenue 253\u003c\/p\u003e \u003cp\u003eChapter 14: Frivolous Drugs? 273\u003c\/p\u003e \u003cp\u003eChapter 15: The Next 100 Years 285\u003c\/p\u003e \u003cp\u003eAcknowledgments 309\u003c\/p\u003e \u003cp\u003eNotes 311\u003c\/p\u003e \u003cp\u003eBibliography 329\u003c\/p\u003e \u003cp\u003eIndex 333\u003c\/p\u003e \u003cp\u003e\u003cb\u003eFRAN HAWTHORNE\u003c\/b\u003e is Senior Contributing Editor of \u003ci\u003eInstitutional Investor\u003c\/i\u003e and has connections deep within the business and finance communities. Hawthorne has been covering health care and business for more than twenty years for \u003ci\u003eFortune,\u003c\/i\u003e \u003ci\u003eCrain’s New York Business, \u003c\/i\u003eand other publications, and she now writes regularly for such newspapers and magazines as the\u003ci\u003e New York Times, Worth,\u003c\/i\u003e and \u003ci\u003eSelf\u003c\/i\u003e. She is the author of \u003ci\u003eThe Merck Druggernaut,\u003c\/i\u003e which is also published by Wiley.\u003c\/p\u003e  \u003cp\u003e“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.”\u003c\/p\u003e\u003cp\u003e\u003ci\u003e—From the Introduction\u003c\/i\u003e\u003c\/p\u003e\u003cp\u003eBecause 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. \u003c\/p\u003e\u003cp\u003eFrom the price of prescription drugs and the dangers of genetically engineered food, to debates over teenage pregnancy and the role of government itself, \u003ci\u003eInside the FDA\u003c\/i\u003e 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.\u003c\/p\u003e\u003cp\u003eIn 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, \u003ci\u003eInside the FDA\u003c\/i\u003e digs deep to reveal the truth about an agency that affects our daily lives more than any other single entity in the world.\u003c\/p\u003e\u003cp\u003e\u003cb\u003eInside you’ll discover: \u003c\/b\u003e\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003eHow the FDA will face its first case of embryonic stem-cell research\u003c\/li\u003e\n\u003cli\u003eWhy the FDA goes so easy on foods that are genetically engineered\u003c\/li\u003e\n\u003cli\u003eHow dangerous drugs like Vioxx get past the FDA’s safety measures\u003c\/li\u003e\n\u003cli\u003eWhen 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\u003c\/li\u003e\n\u003cli\u003eWhy the FDA let drug ads on TV\u003c\/li\u003e\n\u003cli\u003eWhat it’s like to launch a biotech firm and try to move a brand-new drug through the FDA\u003c\/li\u003e\n\u003cli\u003eWhy the FDA’s role is growing more and more beyond science and into public policy\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003ci\u003eInside the FDA \u003c\/i\u003etakes 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. \u003ci\u003eInside the FDA\u003c\/i\u003e 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.\u003c\/p\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":47989432287461,"sku":"NP9780471610915","price":39.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9780471610915.jpg?v=1761784077","url":"https:\/\/k12savings.com\/es\/products\/inside-the-fda-isbn-9780471610915","provider":"K12savings","version":"1.0","type":"link"}