Is the FDA just a money game?
Do those corporations/entities with more resources have a better chance for approval, despite whether or not there are other drugs, etc. that really do deserve FDA approval but aren't getting it?
- Zen CatLv 51 decade agoFavorite Answer
Yes. The traits you described are quite common as corruption grows in bureaucracies.
It is commonly believed the main turning point with the FDA occurred during the process of aspartame's approval.
Despite being moderately corrupt and vulnerable to lobbying, the FDA refused to approve aspartame because the evidence against it was too damning (most of the lab rates developed brain tumors and died etc), even in doctored industry trials.
The owner of the company that developed it was Donald Rumsfeld (a prominent neo conservative). When Ronald Regan (and thus the neoconservatives) came into power, the FDA continued their previous policy of holding some semibalance of integrity by refusing to approve aspartame despite industry pressure. Regan decided to fire the director of the FDA and replace him with an industry person who immediately gave a top down order to approve aspartame.
Ever since then it has been common place for people in the FDA upon leaving to immediately get work in the private sector they are supposed to be policing (and receiving lucrative jobs if they performed well for industry interests while in the FDA) and many FDA bureaucrats to have formally been industry executives.
This entire problem is termed the revolving door, and thusfar no one in the government really wants to tackle it. Until it's dealt with, or there is some form of regulation to force the FDA to behave well, it's highly unlikely to change.
Because this situation exists, every single claim you made is true.
The large pharamacutical companies can have whatever drugs they want approved regardless of what side effects are attached to the drugs (sometimes they even completely bypass the entire approval process), which leads to drug complications being one of the leading causes of death in the United States.
Conversely, the FDA allocates most of it's resources to policing natural/non corporate items (which while infinitely less harmless than drugs and food additives, threaten the profits of industry and hence are targeted).
The FDA was originally approved for very good reasons, but at this point in time I personally believe it does more harm than good, and I've read far to many case studies detailing it's corruption, uselessness in protecting consumers and actual damage it causes to the country.
- Anonymous1 decade ago
Hi, good question, prepare for some arguments though!
The FDA is run by the government. It is not a business intended to create profit.
The aim of the FDA is to keep people safe and the industry fair. Every drug that applies for approval to be sold must pass the SAME tests of efficacy and safety.
I think Gary Y gave a great answer. Hope that helps :)
- Anonymous1 decade ago
No, of course it's not "just a money game". Those are weasel words typically used by quacks and scam artists to foster a distrust of the FDA thus supporting whatever flim flam is they are selling. It is also the position of those who have been suckered by these hucksters, and of course conspiracy theorists.
In fact when you see that being used to promote a product, your quackery red flag should pop up, or your baloney detector should go off.
It is a massive job to "regulate and supervise the safety of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics." http://en.wikipedia.org/wiki/Fda
The New Drug Application is a very rigorous process. But it is the process one must follow to a new drug approved. Safety, risks and efficacy must be assessed.
The FDA is not perfect but they do a lot of good work. For example, just recently they have warned against the use of Zicam, and are taking action against the manufacturers, after 130 consumers reported a loss of smell after using it. Zinc can damage nerves in the nose needed for smell. http://news.yahoo.com/s/ap/20090616/ap_on_bi_ge/us...
So no. Clearly there is a lack of evidence to support that the FDA is "just a money game". I don't think all of the working doctors, scientists, chemists, statisticians etc, who work there would be very impressed with that assertion.
And I have no connections to Big Pharma.
- mama woofLv 71 decade ago
Absolutely it is. Just look at the scandal of Aspartame in the Reagan era to see how the FDA and $ interact to prosper certain people. It has little to do with health and everything to do with cash.