{"product_id":"inside-the-fda-isbn-9781119086758","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 \u003cb\u003eFRAN HAWTHORNE\u003c\/b\u003e 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 \u003ci\u003eFortune\u003c\/i\u003e, \u003ci\u003eCrain's New York Business\u003c\/i\u003e, and other publications, and she now writes regularly for such newspapers and magazines as the \u003ci\u003eNew York Times\u003c\/i\u003e, \u003ci\u003eWorth\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.   \u003cp\u003e\u003cb\u003ePraise for INSIDE THE FDA\u003c\/b\u003e  \u003c\/p\u003e\u003cp\u003e\"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. \u003ci\u003eInside the FDA\u003c\/i\u003e 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.\"\u003cbr\u003e \u003cb\u003e—Elizabeth MacBride\u003c\/b\u003e Health-care writer and former managing editor of \u003ci\u003eCrain's New York Business\u003c\/i\u003e  \u003c\/p\u003e\u003cp\u003e\"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.\"\u003cbr\u003e \u003cb\u003e—Clem Morgello\u003c\/b\u003e Former senior editor and columnist at \u003ci\u003eNewsweek\u003c\/i\u003e, and former senior editor at \u003ci\u003eDun's Review\u003c\/i\u003e  \u003c\/p\u003e\u003cp\u003e\u003cb\u003ePraise for THE MERCK DRUGGERNAUT\u003c\/b\u003e  \u003c\/p\u003e\u003cp\u003e\"[Hawthorne] understands and communicates the incredible complexity of discovering new drugs and introducing them to the market.\"\u003cbr\u003e \u003cb\u003e—\u003ci\u003eThe New York Times\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":47989432484069,"sku":"NP9781119086758","price":40.0,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9781119086758.jpg?v=1761784079","url":"https:\/\/k12savings.com\/es\/products\/inside-the-fda-isbn-9781119086758","provider":"K12savings","version":"1.0","type":"link"}