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I'll give you an example of how medical device companies and often drug companies get around FDA regulation. A device or a drug may be approved for a specific purpose but then the drug company will send it's representatives into the doctor's office and promote what's called an off-label use so simply meaning that the FDA approves a drug or device for a specific purpose and it's labeled for that. This is what the drug is for, shall be used int his way. But the doctor making his or her own independent decision may find that a drug or device can be used safely and efficiently and effectively for another condition. That the drug or device is not labeled for. What's not permitted yet what often happens is that the drug company or the medical device company has a secret agenda and so they get approval from the FDA for a drug or device for one purpose and then they send out their representatives to doctor's offices across the nation and promote an off-label use of the drug or device. They promote it for something that was never approved, in fact, never even suggested to the FDA was an appropriate use. When this off-label type of promotion occurs, it's a violation of law and I'm sure many people have seen some of the significant finds levied against drug companies for off-label usage. Hundreds of millions of dollars. The fact that the drug companies can pay these fines and consider them nothing more than a cost of doing business should give all of us concern about being guinea pigs in this system.

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