I have selfish reasons for my feelings about the FDA.  I'm glad that devices and drugs are tested and approved before being marketed.  I'm unhappy about the process.

Having worked for a major medical device manufacturer, I can say that it's a pain to get things approved by the FDA.  The amount of tests and documentation that we would submit was astronomical: tens of thousands of pages, all of it dry and technical.  We had people on staff whose entire job was to work on FDA submissions.  Then, once everything was ready and submitted, it would take a very long time to get approval.  For example, the supposedly accelerated "real-time" reviews took about six months.  Incredible.

There is one upside for the device companies: thanks to a very recent Supreme Court ruling, devices that have been granted FDA approval have a tremendous amount of shielding from tort claims.

Whereas I definitely find the FDA necessary, I agree with Jeff Keacher that the process is not the most efficient system in the world.  I visited Genentech once that they spoke of how difficult and grueling passing the FDA regulations was.  Products that could drastically change health conditions are not able to get released into the market for nearly a decade because of FDA regulations.  Certainly, there are cases such as in Europe where a underdeveloped drug is released and must be recalled, but in my personal opinion, the FDA goes too far.

FDA is a good system for most of the time in my opinion but when it comes to some cases like treating breast cancer terminal patients, it's like a hope killer when it decided to not approve Avastin.

The whole process of approval takes too long and those particular patients don't have the time to wait.

If you are really interested, do some research on the (unsuccessful) "Wiley Act" of 1906 or the "Food, Drug, and Cosmetics Act" of 1938, which gave the FDA the power oversee safety (and efficacy for drugs) of such products.  One of the most important functions of this act was to put the burden of proof of the safety and efficacy of products on the manufacturer.  Prior to this, the companies could make any claim they wanted with regard to their product--I suppose one would say they had "unrestricted freedom of speech"( to use verbage from a previous post).  The burden of proof was on the consumer, who was likely very sick, if not dead, to prove that they had been harmed by their product.

While the process of conducting trials and gaining approval is a hassle, it is neccessary to protect consumers from suppliers who either knowingly distribute dangerous/ineffective products, or don't do the necessary research to ensure their safety and efficacy.

Without it, unscrupulous "entrepreneurs" would once again take advantage of a system that allows them to turn a quick profit at the expense of public health.

Last edited by Scott.McAlpine (2008-02-24 14:17:05)

I think that there are certainly more barriers to entry than just the FDA that deter small companies from being able to develop life-saving medical devices, medicines, etc. At least with respect to the drug development cycle, even to meet internal quality requirements (assuming that a company were to follow its own standards in the absence of ones provided by the FDA) the time required to test, improve, and retest a drug until it would be considered satisfactory would reflect the a significant amount of the time required for the drug to receive approval. While the FDA perhaps could be operated in a more efficient manner (with the goal being to speed up approval processes, decrease the number of FDA-approved products that are later recalled, etc.), the consumer market would not be left better off were the FDA absent. Thus, despite the FDA's problems (some of which are listed in above posts), they do seem to be making improvements yearly and the public would be well served to see the FDA continue to become more efficient such that delays in releasing drugs, medical devices, etc. to market can decrease going forward.

I see validity in both sides of this argument, and I am not 100% sure which one I am on. However, I just thought I'd point out one more less talked about anti FDA argument that had not shown up in this forum yet. Which is: restricting the drugs that can get into the market limits consumers' choices in what drugs to use. Sure, in principle this is to assure their safety. But what if a consumer is willing to take a certain risk in order to have the opportunity for a certain positive thing a drug might bring? He or she should be allowed to take that risk. While many may think that is a dumb thing to do, at the end of the day people should be allowed to choose what kind of drugs to use and if they make poor choices that is their own fault. Again this isn't to devalue all the other arguments or even my own opinion, just another one I have heard that I thought I'd throw out there.

I think one point that was touched on but should be addressed more in depth is what would happen without an FDA. Just imagine how actually other countries are free-riding on what the FDA is doing to make sure that drugs are safe. As the one starting point for drugs developed for the rest of the world, it is actually more efficient to have a burdensome process in one place. Unfortunately, it does stifle competition at home in the US. Perhaps startups should go overseas first, and then come back?

All great comments and I definitely that Mir's positive support of the gruelling process of FDA besides making the devices safer for the public at large has a number of cascading advantages. I feel that the FDA tends to keep the process of medical device innovation under a check which i think is essential specially when young engineers like myself, full of passion for design enter this industry. Secondly, it also serves to enhance the process of entrepreneurship in countries such as India with minimal med device regualtions in place. FDA regulations provide a sort of a guiding light to communities which are essentially not directly regulated by it but can consider it a benchmark in the absence of other similar local laws.

I agree with Mir Imran that FDA is "essential" and love to hear that he talked about them in such a positive light. As the previous posts suggest, despite the arduous approval process, it's necessary for customers' protection. which certainly increase customers' confidence in products once they're in the market. With such regulations or even the option for some products not to get approved, the customers might still lean towards the approved products. In the worse case, if the consumers are not willing to try new products, this might discourage R&D projects, which is unfortunate.

And in response to Saranwut's quote, I also think that although some R&D projects will be discouraged, it keeps the quality of products higher, as only those who do put in much resources into R&D will go through with the process.  Such an investment most likely means that such a product is pretty valuable.