By Dave B.
So, I rarely talk about this, but I hate the U.S. Food and Drug Administration (FDA). And I don’t use the term "hate" lightly. I think it is easily the worst federal agency in the United States. Part of its mission statement reads: “The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.” (It’s full mission statement can be found here.) On most of these measures it fails. Here are three (out of many, many) examples of why I despise the FDA and want to see it abolished and replaced with an effective agency:
1. Food Security
I’ve got one word for you: Chipotle. Is that not enough? Ok. Real milk in almond milk. E. coli and salmonella in everything. The list goes on. You see, the fact is that outbreaks of contaminated food happen all of the time. I’m not saying that we don’t need an agency to regulate and monitor food safety. I’m saying that the FDA spends billions of dollars a year trying to do so and it’s unclear if they’ve prevented a single instance of food contamination. In fairness, maybe they prevent contamination all the time, but from looking at their website, they have a section on “Recalls, Market Withdrawals, and Safety Alerts” (meaning that all of these products made it to market) and no section on food contamination prevented. Billions of dollars to be glorified journalists, reporting on and warning about dangerous food that they allowed to make it to the public. Think about it.
2. Medical Devices
Now I’ve got three words for you: The Bleeding Edge (you can read my review of it here. Everyone should watch that documentary). Basically, the medical device regulatory regime is a joke and most devices aren’t tested on humans at all. Those that are, are often inadequately tested. The stated purpose of this is “to speed innovations that make medical products more effective, safer, and more affordable”. Maybe that’s true. But when FDA personnel go to work for the industries that they used to regulate, it sounds like regulatory capture of a federal agency by the medical device industry to me.
3. Experimental Treatments
My issue with the FDA on experimental treatments is a bit different than it is with the first two items I mentioned. Instead of regulatory capture or incompetence being the problem, I think that the FDA is far too cautious about allowing terminally ill patients to try experimental treatments. If someone is informed about the inherent risks of trying an experimental drug or procedure, and is willing to accept those risks because they will die anyway, why the hell should the FDA forbid it? I won’t speak for everyone, but I know that if I were terminally ill and there was even a chance that I could survive, I would be willing to take the risk and I would be pissed about a government agency telling me that I am forbidden to do so.
I could go on (and on and on) with other issues that I have with the FDA, but I think you see my point. My main beef with the FDA isn’t that a regulatory agency that covers food, drug, and device safety exists. It’s that I think that with a $5 billion dollar budget, it should be more effective and discerning in the execution of its duties. And because I believe that the rot at the FDA is too wide and deep for reform of the organization to be effective, I think it needs to be replaced. This isn’t a popular opinion. A lot of people just fundamentally disagree with my perspective and I respect that. And since I’m always open to changing my mind and acquiring new data, if anyone would like to share their perspective on why they disagree (or agree) with me on this topic, I would love to hear it!