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FOOD AND DRUG ADMINISTRATION - page 104 / 263

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DR. TSONG:  Yes.  I just had prepared two slides to address the general issue of quality standard.  Could I show them?

DR. KIBBE:  Fine.

DR. TSONG:  First, I want to get permission from Dr. Olsson because I used your slide and twisted it a little bit to get to my point.

(Laughter.)

DR. TSONG:  First, let's talk about the quality standards.  Suppose I'm a drug manufacturer and I have a supplier to supply the material, and so whenever the shipment comes, I have to take a sample to give a quality score of that.  Suppose the perfect score is 100, and once I receive a product which scores 75, I know I'm going to reject the batch, turn it back.

But the chances are I receive a batch which has a score of 90, which I feel, hey, I could cheat a little bit, so I'll pick up the phone and call the supplier, and say this quality is not really what I expected.  I wanted 100, you gave me 90 percent, and you have to pull your act together to give me better product.

Then if I get a score which is 85, and I

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