Re: FDA Writes Own Rules, Doesn't Follow Them

[Guest guest]

Hi,

In (late) response to the article stating how the FDA doesn't even

follow its own rules, I want to point out one more example of how

pathetic the FDA safeguards really are.

I worked for 3 years in the biopharmaceutical industry, supervising and

defeloping quality control assays. In this capacity I learned about

Good Laboratory Practices and Good Manufacturing Practices, which all

drug manufacturers are required to follow.

During the same time my wife worked for a Red Cross blood processing

facility. She came home with lots of stories about how they ignore

standard GLP and GMP. One story was of how one supervisor, trying to

same a couple of bucks, changed brands of sterile saline solution.

Without any prior testing, it was introduced into the automated ABO

testing machine when the other batch ran out. This caused the testing

to fail. Every single unit - thousands by the time it was corrected -

had to be hand tested for blood type.

GMP requires that whenever any change is made in reagents (such as

saline), the new reagent is put into quarantine until it is

demonstrated to work correctly. This demonstration requires several

parallel tests on the same samples, using both types of reagent, done

by QC personnel. Only after it is shown and documented to perform

properly is the reagent released to the working lab.

Other omissions included written Standard Operating Procedures in some

cases - that means that the testing process can change without any

record being made of the change. That type of change can lead to bad

test results, and with no record of when the change was made there is

no way of telling how far back the bad results can run, and with the

product being blood and blood fractions, such errors can be life-

threatening.

During the time that my wife worked there, the FDA announced that it

would start holding the Red Cross to the same standards as other drug

manufacturers, which would include GMP and GLP. The head of the Red

Cross at the time - Dole - announced essentially that if the

FDA tried to hold them to the GMP standards, the Red Cross would simply

stop its blood collection and blood product production. The FDA backed

down.

To this date, the Red Cross does not test its blood in a manner that

guarantees the safety and accuracy of their results. And the FDA will

not even try to change it.

If you need a blood transfusion, try NOT to use Red Cross. Here in Colo

we have Bonfils; in New York City there is the New York Blood Center.

I'm sure there are others I don't know about. And there is also the

best shot, getting a relative to donate directly to you. Again, try NOT

to use the Red Cross for this collection and testing.

Jerry

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> FDA Writes Own Rules, Doesn't Follow Them

> January 15, 2009. By Gordon Gibb