The Problem with the FDA

I've been writing technical documentation for GE Healthcare for a while now and a large part of my daily tasks involve making the FDA happy by filling out form after form.

As you can imagine, the FDA is very concerned about ensuring that people aren't pumped full of too much radiation or too many RF waves when they're put into GE's medical imaging machines. Consequently, they audit us and tell us exactly how to do many things.

The problem is, the FDA is not as good at determining what is the best way to protect patients as GE Healthcare is. As a corporation, GE is the target of many many lawsuits. If, during one of these lawsuits, it can be proven that GE could have done something to protect patients' safety, but chose not to, GE would loose millions and millions of dollars in settlement costs and lost business.

These lawsuits exist even though GE Healthcare already complies with FDA standards. GE Healthcare has found that the FDA's guidelines cannot be relied upon to protect the patient. Why would that be? Well, probably because the government regulators come up with regulations based on political pressure (e.g., OTC morning after pills), popular perception (e.g., child carseats), and pure science (e.g., trans fat). None of these, however, are grounded in the real issue: are people's lives actually improved by having these guidelines.

Companies, like GE, must be concerned about that reality, because telling a jury that "theoretically our precautions should have saved your son...the FDA told us so" just won't cut it. Companies, therefore, must make their own guidelines based on experience to ensure that consumers don't get hurt.

The assumption that corporate America doesn't care about its customers is, the most part, true. But in this post-tobacco settlement America we now live in, corporate America does actually care about its customers' safety and health, because the moment they stop caring, a lawyer will be on them like white on rice with a lawsuit that will devastate their financials and ultimately tick off their stockholders.

Therefore, the claim that "Consumers have no way of knowing without the government," is mistaken exactly because of this reality. Product labeling lists things like ingredients and gives us good advice like -Don't perform arc welding while bathing- exactly because companies want to tell us so we know so we can't say "Hey, I never knew" and sue them.

Obviously, this issue is larger and more complex than I've stated here, and we need government to act as a check to market capitalism otherwise materialist values will always win the day. But, that said, we must acknowledge that the self interests of the companies, i.e., making money, is innately tied up with the well being of their customers. So as long as the government keeps the legal system open to people so they can bring their grievances against negligent companies to court, companies' fear of lawsuits is actually the best protection we have.

In terms of trans fat and cheap food, I totally sympathize with people who want to get that crap out of our food, but I think legislating a change is merely changing the law without changing people's hearts and that's not really good for society. Companies want a system where people take responsibility for their actions.
Companies want a world where

* they make Funyuns,
* they put a label on Funyuns that says "100% transfat", and
* people who want die earlier buy Funyuns.

If the person does die at the age of 57--which, of course they will--that's sad, but, hey, they got to experience the joy of Funyun's yummy goodness in a way that most octogenarians who avoided them never did. That may sound harsh, but it at least in that world scenario people are taking responsibility for their actions and aren't living a life dictated by politicians. That's a world where people are free to choose between good and evil and in so doing, continually shape their will towards God's--or as is more often the case, see that their will is so bent on their own destruction, they need to turn to Christ and cling to the cross. Either way, God's will is done.