Thoughts concerning generic issues
Posted 05-10-19 at 03:26 AM by wonderboy
Invariably for every positive review of a generic, you will find a negative review.
The problems outlined
When the generic firm decides to produce a product and submit a ANDAto the FDA, The bioequivalency testing is conducted by the firm, with very little oversight by the FDA.
A. POOR EXTERNAL VALIDITY:
When generic companies conduct tests concerning bioequivalency, they may only have less than 10 to 15 individuals, and within the population,
there may not be anyone older than 60.
This is a example of poor external validity
B. Generic firm results not made available to public
Why not.....????
C. Poor FDA oversight regarding the generic firm’s testing
Remember when you were in middle school,
and the teacher said:
“You can just grade your own test”
That is very much what it is like with respect to FDA oversight with regard to Bioequivalency
D. Inspection by the FDA of the plants in Third World countries
Yes… Most generics are made there, and God knows what the quality is like
E. + or -25% Bioequivalency (Hatch-Waxman act 1984)
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The problems outlined
When the generic firm decides to produce a product and submit a ANDAto the FDA, The bioequivalency testing is conducted by the firm, with very little oversight by the FDA.
A. POOR EXTERNAL VALIDITY:
When generic companies conduct tests concerning bioequivalency, they may only have less than 10 to 15 individuals, and within the population,
there may not be anyone older than 60.
This is a example of poor external validity
B. Generic firm results not made available to public
Why not.....????
C. Poor FDA oversight regarding the generic firm’s testing
Remember when you were in middle school,
and the teacher said:
“You can just grade your own test”
That is very much what it is like with respect to FDA oversight with regard to Bioequivalency
D. Inspection by the FDA of the plants in Third World countries
Yes… Most generics are made there, and God knows what the quality is like
E. + or -25% Bioequivalency (Hatch-Waxman act 1984)
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