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

by Fran Hawthorne

Book Overview

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...

• Format: Hardcover
• Language: English
• ISBN: 0471610917
• ISBN13: 9780471610915
• Release Date: February 2005
• Publisher: Wiley
• Length: 338 Pages
• Weight: 1.20 lbs.
• Dimensions: 1.3" x 6.3" x 9.1"

Customer Reviews

Everything you want to know about the FDA.

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. No matter how you look at it, the FDA is under a huge amount of political pressure. Unlike the Federal Reserve they are not an independent branch of government. Their livelihood (Budget) is almost solely dependent on the goodwill of Congress. And, Big Pharma lobbies Congress to death. Thus, the FDA is always under huge pressure to do the right thing by its boss, Congress, who in turn does the right thing by its customer-constituent Big Pharma. Exacerbating those conflicts of interests even more, now a good part of the FDA's budget is financed by fees approved by Congress it earns directly from Big Pharma. This is the exact same conflict of interest that caused the housing and credit crisis. Moody's and S & P gave AAA ratings to mortgage securities that should have been rated BB at best in part because the rating agencies are paid by the security issuers. Fortunately, consumer groups and related liabilities mount a counter pressure to Big Pharma that forces the FDA to maintain its proper balancing act. The author taught me a bunch of things I did not know about this whole business. Some are downright funny. I always wondered about drug advertising on TV. Remember when we were bombarded by drug TV commercials and the commercial did not even tell you what the drug was for. It just told you to ask your doctor

The FDA's job may not be able to be justified

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

Interesting look at an important regulatory body

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.

Fascinating, Informative Look at Food & Drug Administration

"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.

Amazing book, although it misses one key insight

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.