Nothing makes me decide someone is an unserious thinker than the line “There are too many regulations” when discussing drug development and manufacturing. Okay, which one? Point to me the regulation you want to get rid of? Because frankly they all exist mostly as reactions to the crap some corporation got up to.
I am going to be honest. I don’t trust corporations to do the right thing. Otherwise we wouldn’t have problems like we see in OTC and consumer goods. Just look at this recent article on cancer causing shampoos, sunscreens and tampons. And that is the tip of the iceberg if you ask me. Don’t even get me started on the risks in generics coming from China and India. Or the mess that is the supplement industry.
So definitely put me in the category of regulations are a good thing. Are some poorly written? Sure. Are there some that need updating? Definitely. But as a whole 21CFR chapter 1 is a pretty decent set of regulations (don’t ask me about the other chapters, I rarely use them). The European Eudralex, pretty straightforward (okay I would get rid of QPs and RPs and all the rest but that is a cultural thing).
I personally think we don’t go far enough. I want to write the regulation that requires every c-suite in every pharma, med device, OTC, consumer goods, supplement and food company to do an intense reading of the Jungle and then quarterly restorative justice sessions with victims of badly executed decision making. I want to see a regulation makes executives and board members truly accountable. I want to stop reading horror stories and seeing recalls.
Investigations of a Dog 