صيدلانية سعودية
مشرفة قسم الصيدلة
Inside the FDA: The Business and Politics Behind the Drugs We Take and the Food We Eat
by Fran Hawthorne
by Fran Hawthorne
Publisher: Wiley
Number Of Pages: 338
Publication Date: 2005-02-25
ISBN-10 / ASIN: 0471610917
ISBN-13 / EAN: 9780471610915
Binding: Hardcover
Number Of Pages: 338
Publication Date: 2005-02-25
ISBN-10 / ASIN: 0471610917
ISBN-13 / EAN: 9780471610915
Binding: Hardcover
Book Description:
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 [FONT=arial,helvetica,clean,sans-serif][FONT=arial,helvetica,clean,sans-serif]prescription [/FONT][/FONT][FONT=arial,helvetica,clean,sans-serif][FONT=arial,helvetica,clean,sans-serif]drugs[/FONT][/FONT] and the role of government itself, Inside the FDA takes readers on an intriguing [FONT=arial,helvetica,clean,sans-serif][FONT=arial,helvetica,clean,sans-serif]journey[/FONT][/FONT] 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 [FONT=arial,helvetica,clean,sans-serif][FONT=arial,helvetica,clean,sans-serif]real-world[/FONT][/FONT] 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 [FONT=arial,helvetica,clean,sans-serif][FONT=arial,helvetica,clean,sans-serif]closer [/FONT][/FONT]
[FONT=arial,helvetica,clean,sans-serif][FONT=arial,helvetica,clean,sans-serif]look[/FONT][/FONT] 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 [FONT=arial,helvetica,clean,sans-serif][FONT=arial,helvetica,clean,sans-serif]New [/FONT][/FONT][FONT=arial,helvetica,clean,sans-serif][FONT=arial,helvetica,clean,sans-serif]York[/FONT][/FONT] Business. She is the author of The Merck Druggernaut (cloth: 0-471-22878-8; paper: 0-471-67906-2).
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 [FONT=arial,helvetica,clean,sans-serif][FONT=arial,helvetica,clean,sans-serif]prescription [/FONT][/FONT][FONT=arial,helvetica,clean,sans-serif][FONT=arial,helvetica,clean,sans-serif]drugs[/FONT][/FONT] and the role of government itself, Inside the FDA takes readers on an intriguing [FONT=arial,helvetica,clean,sans-serif][FONT=arial,helvetica,clean,sans-serif]journey[/FONT][/FONT] 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 [FONT=arial,helvetica,clean,sans-serif][FONT=arial,helvetica,clean,sans-serif]real-world[/FONT][/FONT] 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 [FONT=arial,helvetica,clean,sans-serif][FONT=arial,helvetica,clean,sans-serif]closer [/FONT][/FONT]
[FONT=arial,helvetica,clean,sans-serif][FONT=arial,helvetica,clean,sans-serif]look[/FONT][/FONT] 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 [FONT=arial,helvetica,clean,sans-serif][FONT=arial,helvetica,clean,sans-serif]New [/FONT][/FONT][FONT=arial,helvetica,clean,sans-serif][FONT=arial,helvetica,clean,sans-serif]York[/FONT][/FONT] Business. She is the author of The Merck Druggernaut (cloth: 0-471-22878-8; paper: 0-471-67906-2).
Summary: The FDA's job may not be able to be justified
Rating: 5
Rating: 5
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 [FONT=arial,helvetica,clean,sans-serif][FONT=arial,helvetica,clean,sans-serif]stock[/FONT][/FONT] in the very company which is being checked. They allow advertising of rx products on
[FONT=arial,helvetica,clean,sans-serif][FONT=arial,helvetica,clean,sans-serif]TV[/FONT][/FONT],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
[FONT=arial,helvetica,clean,sans-serif][FONT=arial,helvetica,clean,sans-serif]TV[/FONT][/FONT],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
Summary: Highly Informative (and Neutral) Look at the FDA
Rating: 4
Rating: 4
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.
Summary: If you want to know about an administration that controls a third of our economy, this is the first step.
Rating: 3
Rating: 3
If you know nothing of the FDA, than this will blow your mind. By the time you are through half the book you will be considered an expert on the subject by all your friends.
Not one of the more exciting reads, but extremely informative. Not just about what you might think it is about, but much much more. This book will give a clearer view of where we all live.
Summary: Interesting look at an important regulatory body
Rating: 5
Rating: 5
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.
Summary: Fascinating, Informative Look at Food & Drug Administration
Rating: 5
Rating: 5
"Inside the FDA" is a thoughtful, balanced, and well-researched look inside the controversial and troubled Food and Drug Administration. Author Fran Hawthorne is an experienced business journalist and her skills are evident here.
Digging into the FDA's complex and conflicting world, the book provides an informative picture of FDA's bureaucratic, political, and scientific drivers. Ms. Hawthorne does an excellent job of laying out what the FDA is suppose to do, what is really does, and where and why it fails.
It makes for a great read.
