Although it is cynical I think there exists one reason and one reason alone that companies do not strictly follow the FDA guidelines and do not change their protocols, money. If we continue with Dr. Simon’s analogy of the speeding ticket, yeah it hurts the reputation but people are very quick to forget and there is so much money to be made that companies simply don’t care. If I know that the speeding ticket will be $100 but by speeding I will make $200 but would only make $90 if I didn’t speed then why would I not speed. If I don’t get caught then I’m making $200 and if I do then I make $100. It’s more either way. As much as it would be nice to think that these companies are always acting in good and ethical ways we need to look at the reality that these companies are run by businessmen who want only money and to grow the stock price of the company. They will cut any and all possible corners short of killing patients in order to increase profits. If they know all they will receive is a slap on the wrist then there is no way they are going to be compliant with the regulations. As long as their product aren’t killing people then they won’t care. The only way to make punishments stick is to hit them in the bottom line, so to do that the FDA would have to raise the amount companies have to pay if they receive a Form 438.