I work in the pharmaceutical industry and often times I hear about how we have a very rigid framework and how, at least on the production side, innovation is very limited. I’m guessing the same is true for the aerospace industry, the dairy industry or well, anything where the government has a say in what ends up in the consumer’s hands.
However, regulations are simply the limits of what you can do. Those guidelines are really the framework of any possible innovation. Indeed, in the quality department, we went from testing endotoxins in rabbits to finding a way to use horseshoe crab serum without even killing them. In the production department, our machines get insanely efficient while being safer than ever, both for the consumer and the operator.
Obviously, bad regulations might stifle innovation. A document saying that you must use a particular technique without giving an overarching rationale will have companies simply and stupidly applying the law. For example, the early interpretation of the 21 CFR Part 11 regulation, which aimed to put the basis of paperless systems within the pharmaceutical industry probably scared quite a few people out of using computers in their business with the FDA, at least for a while. However, when you know the reason, you will try to find better ways to achieve that goal. This is how we went from testing for contamination using century old Pasteur’s techniques to having the rapid microbiology machines.
Another thing that I feel a lot of people in the industry do not understand is that the FDA is on their side (interestingly enough, people outside the industry understand this and maybe take this fact to the other extreme). The first goal of any agency is to ensure the safety of the general public. The second goal of the agency is to insure the survival and the growth of the industry for which it was created. This means that, up to a point, agency will welcome any innovation that the companies make that result in both of their goals being met.
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